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Ensuring Drug Product Integrity: Key Considerations from FDA’s Draft Guidance on 21 CFR 211.110

07 Jan, 2025

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The FDA has issued a draft guidance document titled Considerations for Complying With 21 CFR 211.110 to enhance batch uniformity and ensure drug product integrity. This guidance is particularly relevant for manufacturers navigating current good manufacturing practice (CGMP) regulations. It emphasizes the importance of in-process controls, advanced manufacturing technologies, and scientifically grounded monitoring systems to maintain product quality throughout the manufacturing lifecycle.

The Importance of 21 CFR 211.110

The guidance highlights the FDA’s expectations for drug product manufacturing under 21 CFR 211.110. This regulation mandates manufacturers to design processes that consistently meet predetermined quality standards. It applies to both human and animal drug products, including biologicals, but not to active pharmaceutical ingredients (APIs).

Key requirements under this regulation include:

Establishing written procedures for in-process sampling and testing.
Monitoring critical quality attributes to maintain a “state of control” during production.
Ensuring batch uniformity through scientifically validated control strategies.

Advanced Manufacturing and Process Models

The guidance underscores the potential of advanced manufacturing technologies, such as continuous manufacturing and 3D printing, to improve efficiency, robustness, and drug availability. Advanced manufacturing integrates innovative approaches like real-time quality monitoring and process analytical technology (PAT) to enhance product reliability.

Process models play a pivotal role in these advancements by predicting in-process material attributes and drug quality. However, the FDA stresses that models must incorporate robust monitoring systems to ensure continued validity during routine manufacturing.

In-Process Sampling and Testing

The timing and location of in-process sampling.
The methods used, which can include innovative technologies like at-line, on-line, or in-line testing.

By adopting a risk-based, scientifically sound approach, manufacturers can ensure that drug products meet quality standards while reducing unnecessary interventions. The FDA also recognizes the importance of adaptive strategies that cater to both batch and continuous manufacturing processes.[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”4″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Challenges and FDA’s Stance on Process Models

While process models offer significant advantages, the FDA notes limitations in relying solely on them. Current models cannot always detect unplanned disturbances or deviations from assumptions, potentially compromising product quality. To address this, the guidance recommends pairing process models with in-process testing or monitoring to maintain quality and regulatory compliance.

FDA’s Commitment to Innovation

The FDA supports the industry’s transition to advanced manufacturing through initiatives like the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME). The agency encourages early engagement with its Emerging Technology and Advanced Technologies Teams to explore alternative control strategies. These collaborations aim to foster innovation while upholding rigorous quality standards.

Conclusion

The draft guidance on 21 CFR 211.110 offers a forward-looking framework for manufacturers to enhance product quality and embrace advanced manufacturing techniques. By aligning with the FDA’s recommendations, companies can ensure compliance, improve efficiency, and contribute to the availability of high-quality medicines.

The FDA invites public comments to refine this critical guidance, ensuring it effectively addresses industry needs and challenges.

Download the FDA draft guidance document – “Considerations for Complying With 21 CFR 211.110”.

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Starting your journey towards meeting with the FDA regulatory requirements? Let Celegence assist you. Reach out to us today to explore the possibilities of partnering with Celegence’s regulatory team. For more information reach out to us at info@celegence.com, contact us online or learn more about our service offering on our services page.

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Streamlining Post-Authorization Changes: Key Updates to the EU Pharmaceutical Variation Guidelines

20 Jun, 2024

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margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Streamlining Post-Authorization Changes: Key Updates to the EU Pharmaceutical Variation Guidelines

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]As part of the 2020 Pharmaceutical Strategy for Europe, the Commission is reviewing the current rules governing the procedures for post-authorization changes to the terms of a marketing authorization for medicines products for human use, with the purpose to make the lifecycle management of medicines more efficient and future-proof.

In this context, the Commission has now proposed amendments to the variation classification guideline. Read the guidelines here.[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Overview of the Main Changes[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

New/Revised Tools: Super grouping of Type IA variations and annual updates of Type IA variations are among the new tools proposed. There will also be mandatory use of work-sharing to streamline processes.
Flexibility for Human Vaccines in Public Health Emergencies: The extension of flexibility to human vaccines addresses public health emergencies in the Union, ensuring rapid response capabilities.
Integration of Previous Article 5 Recommendations: Previous Article 5 recommendations for unforeseen variations have been integrated into the new framework.

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Revised Variation Framework for Biological Active Substances and Finished Products[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

Strengthening Knowledge and Documentation Requirements for Active Substances: The framework for changes to active substances, including ASMFs and CEPs, has been updated to emphasize that the Marketing Authorization Holder (MAH) has adequate knowledge of the quality of the active substance. This includes strengthening the conditions and documentation requirements in line with the responsibilities of the MAH and finished product manufacturer.

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Changes to Variations Affecting Medical Devices[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

New Scopes for Integral, Co-Packaged, and Product Information Referenced Devices: New scopes have been proposed to cover integral, co-packaged, and product information referenced devices, taking into account the new requirements of the Medical Devices Regulation and the Guideline on quality documentation for medicinal products when used with a medical device. This focuses on risk-based classification based on impact and risk rather than the type of device.
Simplification of Plasma Master File Variations: Plasma Master File variations have been reviewed and simplified, making it easier to manage changes.
Added and Deleted Changes in the Variation Framework: Some changes have been added or deleted, such as the deletion of changes currently being made through the XEVMPD database. Provisions have also been added to make it possible to explore additional options and further optimize lifecycle management.

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Next Steps and Stakeholder Engagement[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

Open for Review Until August 23rd, 2024: The proposed amendments are open for review until August 23rd, 2024. Stakeholders are encouraged to provide feedback.
Anticipated Second Revision Post-EU Reform: A second revision to the variation framework is foreseen once the EU reform is completed.

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Celegence Can Help[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

Need help in understanding how the proposed changes are going to impact your way of working? Please reach out to Celegence. Our Regulatory Intelligence department can help you. Or do you need support in planning for and submitting your variations? Our Regulatory Affairs Strategy and Publishing & Submission colleagues are ready to help.

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Celegence, led by Sonia Veluchamy provides cutting-edge consulting services and technology-driven solutions that are tailored to the evolving operational and strategic needs of manufacturers. Our suite of pharmaceutical services allows you to focus on core activities while we work as an extended part of your regulatory team to ensure compliance and efficiency. Besides the services we provide, our advanced cloud-based dossier management solution, Dossplorer™ eliminates manual steps in the exchange of regulatory dossiers and allows you to share, view, and review eCTD, NeeS, and other dossier formats from any region and access them in any location!

Contact us at info@celegence.com to discuss any EU pharmaceutical regulatory concerns you might have and learn how our team of regulatory affairs consultants can help ensure successful regulatory outcomes for your product.

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An Assessment of the EU Parliament Amendments to the Commission Proposal of the EU Pharma Package

15 May, 2024

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AN ASSESMENT OF THE EU PARLIAMENT AMENDMENTS TO THE COMMISSION PROPOSAL OF THE EU PHARMA PACKAGE

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The European Parliament recently published its amendments to the draft text on the Commission’s proposal for updating the EU pharmaceutical legislation. This blog covers the significant updates, including regulatory data protection, managing supply shortages, environmental impact assessments, and transparency enhancements. The amendments also address accelerated approvals, platform technology master files, and electronic product information. As the Council of the European Union prepares to finalize its position, these changes will influence pharmaceutical regulation for years to come.

Key changes that are introduced after the first reading include the following:

Significant changes related to regulatory data protection, both related to conditions and duration (see Figure ‘Regulatory Data Protection (RDP) Period’ below).
Additional details and requirements related to the management of supply shortages.
Further increased focus on environmental impact in the benefit-risk assessment of medicinal products (in addition to the assessment of quality, safety, and efficacy).
Expansion of the environmental risk assessment to also include the environmental impact of manufacturing, besides the impact of usage and disposal.
Further increased focus on transparency: an increasing amount of information to be made publicly available (e.g. redacted PSUR, RMP, ERA, info on experts involved in scientific advice, and separation of those involved in pre-submission activities and the actual dossier review).
Additional details on penalties in cases of non-compliance with the legislation.
Additional details on the involvement of (ad-hoc) working parties will be established to ensure that expertise will remain despite the discontinuation of the specialized committees (PDCO, COMP, and CAT).
Introduction of the possibility for accelerated approval for variations (in addition to initial MAAs).
Introduction of the use of platform technology master files, which will also be applicable to cell and gene therapy.
Additional details on the use of electronic product information and paper leaflets.
Additional details on non-routine hospital exemptions for ATMPs.

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Next Steps

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It is now up to the council, consisting of all 27 EU member states, to reach a consolidated council position on the pharma package. Once the Council has adopted its position, trilogue negotiations between the Commission, the Council and the European Parliament can begin. During that trilogue they can decide on adoption of the package or agree on a second reading.

The file will be followed up by the new Parliament after the European elections on 6-9 June 2024.

Assuming that trilogue will not take place until 2026 and accounting for a transition period of 18 months after the entry intro force, it is generally not expected the new legislation will go into effect until 2028. However, given the long development timeline of pharmaceutical products, the proposal (especially RDP related provisions) might impact products currently in the development pipeline.

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Need pharmaceutical regulatory support?

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FDA Guidance: Navigating Annual Reportable Labeling Changes for Nonprescription Drug Products

08 Apr, 2024

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margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2024/04/FDA-Guidance-on-Annual-Reportable-Labeling-Changes-for-Nonprescription-Drug-Products-Pharmaceutical-Regulatory-Update-Celegence-cover.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” flex_grow=”0″ top_margin=”30px” bottom_margin=”” width=”” height=”20″ alignment=”center” border_size=”” weight=”” amount=”” sep_color=”” hue=”” saturation=”” lightness=”” alpha=”” icon=”” icon_size=”” icon_color=”” icon_circle=”” icon_circle_color=”” /][fusion_title title_type=”text” marquee_direction=”left” 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Navigating Annual Reportable Labeling Changes for Nonprescription Drug Products: FDA Guidance Explained

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Introduction

In the realm of nonprescription drug products, even minor labeling changes require careful consideration and documentation to ensure regulatory compliance and consumer safety. The Food and Drug Administration (FDA) has released comprehensive guidance to assist applicants of approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) in navigating the process of documenting such changes in annual reports. Let’s delve into the key aspects outlined in this guidance. The guidance is aimed at applicants of approved NDAs and ANDAs, helping ensure that consumers have timely access to the most current labeling information for the safe and effective use of nonprescription drug products.

The FDA is accepting comments on the draft guidance until 13 May 2024. Stakeholders are encouraged to review the document and submit their comments by this date. For those who cannot submit comments online, there is an option to mail written comments to the specified docket number: FDA-2023-D-5616. The guidance is currently in draft form and is being distributed for comment purposes only. It contains non-binding recommendations and is not yet implemented.

Understanding the Draft Guidance

The draft guidance, titled “Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products,” provides recommendations for applicants of approved NDAs and ANDAs on documenting minor labeling changes in their next annual report. It aims to clarify what constitutes minor changes and how to document them in accordance with FDA regulations.

Importance of Minor Labeling Changes

Minor errors or updates in labeling may seem inconsequential, but in the highly regulated landscape of nonprescription drug products, even small modifications can have implications for consumer safety and product effectiveness.

These minor changes can be implemented immediately by the applicant without submitting a supplement to the FDA. However, the applicant must document these minor changes, including minor labeling changes, in their next annual report.

The annual report should include a summary of all changes in labeling, including minor changes, made since the last report, listed chronologically by date of implementation, or a statement indicating no changes have been made.

The FDA’s guidance aims to provide clarity on what constitutes minor changes and how to document them appropriately.

Examples of Editorial or Similar Minor Labeling Changes

Editorial: Correcting misspellings, punctuation, or grammar.
Packaging Information: Updating manufacturer, packer, or distributor information. Modifying packaging elements (eg: NDC numbers, UPCs, or graphics).
Artwork: Adjusting design or color schemes of package labels. Relocating logos or graphics while ensuring readability is maintained.

Additional Considerations

Changes to Drugs Fact Label (DFL):
- Typically, alterations to the content within the DFL are not considered minor changes and cannot be documented in an annual report.
- However, specific changes to the DFL, such as color adjustments or relocating the tamper-evident statement, may qualify as minor changes.
Impact of Multiple Minor Changes:
- Implementation of multiple minor changes collectively could potentially affect consumers’ understanding of essential labeling information.
- In such cases, applicants should opt to submit a supplemental application rather than relying solely on an annual report.
- FDA may request a supplemental NDA or ANDA if an applicant includes multiple changes in their annual report, particularly if the alterations significantly alter the appearance of the product packaging.

Engagement and Feedback

The FDA encourages stakeholders to actively engage with the guidance and provide feedback within the specified timeframe. This collaborative approach ensures that the guidance remains relevant and effective in addressing the evolving needs of the industry.

Conclusion

Navigating minor labeling changes for nonprescription drug products requires attention-to- detail and adherence to regulatory guidelines. By following the FDA’s comprehensive guidance, applicants can streamline the documentation process while maintaining compliance and ensuring consumer safety. Stay informed, stay compliant, and contribute to shaping the future of nonprescription drug product regulation.

Download the FDA draft guidance document – “Navigating Annual Reportable Labeling Changes for Nonprescription Drug Products: FDA Guidance” here.

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FDA Updates Recognized Consensus Standards Database with List 61

14 Feb, 2024

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margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ 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FDA Updates Recognized Consensus Standards Database with List 61

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

The U.S. Food and Drug Administration (FDA) has released List 61 which is an update to the Recognized Consensus Standards Database. It includes new standards, updated versions, and revisions to the extent of recognition for existing standards.

Facts About This Update

One significant addition is ANSI/AAMI SW96:2023 Standard for Medical Device Security – Security Risk Management for Device Manufacturers that focuses on medical device security. This key consensus standard addresses cybersecurity concerns and aligns with international safety risk management standards and provides crucial direction for manufacturers in managing cybersecurity risks in device design.

Why Is This Important?

List 61 also contains updates to new versions for two existing standards, and revisions to the extent of recognition for three existing standards under the Accreditation Scheme for Conformity Assessment (ASCA).

The FDA plans to publish the next Federal Register notice in 2024. Meanwhile, manufacturers are encouraged to cite these changes in their submissions while aligning with FDA guidance on voluntary consensus standards.

Reference

Recognized Consensus Standards: Medical Devices

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FDA Issues a Final Rule Amending the Quality System Regulation (QSR)

14 Feb, 2024

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filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2024/02/FDA-Issues-a-Final-Rule-Amending-the-Quality-System-Regulation-QSR-Medical-Devices-Regulatory-Update-Celegence.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” flex_grow=”0″ top_margin=”30px” bottom_margin=”” width=”” height=”20″ alignment=”center” border_size=”” weight=”” amount=”” sep_color=”” hue=”” saturation=”” lightness=”” alpha=”” icon=”” icon_size=”” icon_color=”” icon_circle=”” icon_circle_color=”” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”1″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” 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FDA Issues a Final Rule Amending the Quality System Regulation (QSR)

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The Food and Drug Administration (FDA) has issued a final rule amending the Quality System regulation (QSR). The title of the regulation has also been amended and will now be officially referred to as the Quality Management System Regulation (QMSR). The revision integrates ISO 13485:2016 requirements into the current framework of 21 CFR 820.

Final Rule Amending the Quality System Regulation (QSR)

The new rule modified the current good manufacturing practice (CGMP) requirements for devices within the Quality System (QS) Regulation under 21 CFR 820. This change aims to align more closely with the globally recognized ISO 13485:2016 standard as the FDA deems them significantly similar to the existing requirements providing an equivalent level of assurance in a firm’s quality management system and its ability to consistently produce safe, effective and high-quality medical devices.

FDA’s Revised Quality System Requirements for Medical Devices

The final rule establishes additional requirements within part 820 to clarify expectations and concepts used in ISO 13485. This ensures a seamless integration without creating inconsistencies with other applicable FDA requirements. Conforming edits have been made to part 4 (21 CFR part 4) to clarify Quality Management System (QMS) requirements for combination products. These edits do not impact the CGMP requirements for combination products.

The regulation takes effect two years after being published in the Federal Register. During this period, manufacturers must adhere to the QS regulation. The FDA will enforce the QMSR requirements starting from February 2, 2026.

References

Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions
Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices (CGMP)
Medical Devices; Quality System Regulation Amendments

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EU Clinical Trials to be Transitioned to the New CTIS Portal by January 2025

17 Jan, 2024

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margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ 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display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”1″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” 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All EU Clinical Trials to be Transitioned to the New CTIS Portal by January 2025 – Don’t Wait, Act Now!

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Since January 2022, the new Clinical Trial Regulation (CTR) has been in force, which replaced the Clinical Trial Directive (CTD). With the CTR, also a new online portal for clinical trials, the Clinical Trial Information System (CTIS) is introduced. Sponsors and regulators use this single-entry point for clinical trial data for all submissions and assessments. Currently, we are in the middle of a transition period from the previous EudraCT system to CTIS. Since January 2023, all new clinical trial applications already have to be submitted via CTIS.

For clinical trials approved under the CTD, that will still be ongoing with at least one active site within the EU/EEA after the 30th of January 2025, it is mandatory to be transitioned to CTIS. To prevent the risk that a study must be terminated due to not being transitioned in time, the transition process should be started on time. Thereby taking into account a standard review timeline of 60 days, which may be prolonged by possible requests for information (RFIs) and/or the two-week winter clock stop. Furthermore, a transitional CTA cannot be submitted when there are ongoing assessments (e.g., substantial amendments). Therefore, good planning is key! We offer support in transitioning your clinical trial(s) to CTIS, in case help is required.

Do you have a trial still in EudraCT, of which it is likely that the study will still run by the end of January 2025? Do not hesitate to reach out so we can assist you in harmonizing documents across countries and making sure the right steps are taken to successfully transition your trial on time.

Reach out to us today to explore the possibilities of partnering with Celegence’s regulatory team. For more information reach out to us at info@celegence.com, contact us online or learn more about our service offering on our services page.

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EMA Update on On-site GMP and GDP Inspections Approach for 2024

13 Dec, 2023

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margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ 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EMA Update on On-site GMP and GDP Inspections Approach for 2024

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The latest news on the approach in 2024 by the GMP/GDP Inspectors Working Group is that the validity of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) certificates has been extended until 2024 or until the completion of the next on-site inspection, whichever comes first, unless otherwise stated in the document.

This extension is due to the considerable number of postponed inspections that still need to be carried out following the COVID-19 public health emergency. The GMP/GDP Inspectors Working Group is expected to issue guidelines on the approach for 2024 in the coming months.

This document will likely address the following topics:

Specific arrangements for remote working of Qualified Persons
A clear plan for completing all postponed inspections
Guidance on how to manage the transition to full compliance with GMP and GDP regulations

In the meantime, manufacturers should continue to comply with all applicable GMP and GDP regulations. They should also be prepared to cooperate with inspectors when their inspections are scheduled.

Here are some additional resources that you may find helpful:

Phasing out of extraordinary COVID-19 regulatory flexibilities: https://www.ema.europa.eu/en/news/phasing-out-extraordinary-covid-19-regulatory-flexibilities
European Medicines Agency (EMA): https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice
GMP/GDP Inspectors Working Group: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice/gmp-gdp-inspectors-working-group
European GDP Association (EGPA): COVID-19 and Good Distribution Practice (GDP): https://www.good-distribution-practice-group.org/home.html

Starting your journey towards meeting with the EU pharma regulatory requirements or need support in understanding the impact of the revised EU pharma legislation, please reach out to us. Let Celegence assist you. Reach out to us today to explore the possibilities of partnering with Celegence’s regulatory team. For more information reach out to us at info@celegence.com, contact us online or learn more about our service offering on our services page.

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An Inside Look: The European Commission Publishes the First Union List of Critical Medicines

13 Dec, 2023

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margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ 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An Inside Look: The European Commission Publishes the First Union List of Critical Medicines

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

Shortages of medicinal products are an increasing problem in the EU, therefore, one of the objectives of the new proposed European pharma REFORM is to enhance the security of supply and ensure medicines are available to patients in the EU. The new proposed pharma regulation sets out the specific rules on the security of supply of critical medicines.

But while awaiting the new regulation to become effective, several European actions have are already been set up to prevent shortages in EU on the short-term. Today, the compilation of the Union list of critical medicines has been established, see link to EMA website: https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-and-availability-issues/availability-critical-medicines

Next Steps

Next, the vulnerabilities in the supply chain of these critical medicines will be analysed and measures may be recommended to prevent shortages for these medicines, as its unavailability could cause significant harm to patients and pose substantial challenges to health systems.

The proposed measures, including recommendations for companies to diversify suppliers or increase production within the EU, investment incentives and additional regulatory obligations for companies, will apply to those companies, who market one of the medicines belonging to this Union list of critical medicines.

Recommendations

Hence, it is recommended that each company reviews this list and that priority is given to those critical medicines in the prevention against shortages. In addition, it is important to continuously monitor the ongoing proposed measures and position your company accordingly, to remain compliant with the current legislation and avoid critical setbacks in the future.

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FDA Scheduled Updates for the CDRH Customer Collaboration Portal Including New Features (and Penguins)

13 Dec, 2023

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margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ 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FDA Scheduled Updates for the CDRH Customer Collaboration Portal Including New Features (and Penguins)

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

On December 15, 2023, the FDA will begin the CDRH Portal (Customer Collaboration Portal) deployment in which new features will be added, adjusting the Christmas lights, and sweeping out the hearth.

The Portal deployment will run from 21:00 ET on Friday, December 15^th to 02:00 ET Saturday, December 16^th. While the Portal will be accessible and generally functional during this time, you may experience intermittent disruptions and we recommend you avoid uploading any submissions.

New Features:

De Novo submissions will now be trackable!

After this release is live, the progress tracking functionality will include support for De Novo submissions in addition to the currently supported Pre-Submissions and 510(k) types. If you are the Official Correspondent of an active De Novo, you should see it on your Portal dashboard by Sunday December 17th. If you have questions about who qualifies as the “Official Correspondent” please see the related article in Portal Help > Common questions.

User Fee and Format Hold now supported in progress tracking for original submissions

You asked for it, and now it is here! You now will be able to track a supported submission when it is on user fee and/or format (usually eCopy) hold. Any 510(k)/De Novo original, or Pre-Sub original/supplement will display in the tracking section if it is on user fee hold and/or format hold. Previously submissions only appeared in the tracking section once they had been verified to have a valid format and user fee payment (when applicable).

New “Device Name” and “Company Name” optional columns added to the tracking table

You can now edit the columns that appear in the progress tracking section of the Portal home page, including temporarily adding both “Device Name” and “Company Name” columns. You will not be able to save that customized view, though we hope to add that functionality in a future release.

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margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ 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animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” 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You can now tell which submissions in the tracking section have been shared with you

With the ability to share the progress tracking of a submission in the Portal with other team members (see the Portal help > Common questions section to learn more about that feature) some confusion was caused for folks as it was not clear which submissions were “theirs” (they are the Official Correspondent) and which had been shared with them. All submissions for which the progress tracking has been shared with you will now display an icon indicating their shared status.

[/fusion_text][fusion_imageframe image_id=”17307|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”FDA Regulatory Update – CDRH Portal Deployment – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” magnify_full_img=”” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2023/12/FDA-Regulatory-Update-CDRH-Portal-Deployment-Celegence.jpg[/fusion_imageframe][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

Penguins?

Bjorg the penguin has existed in the Portal since the beginning. However, he has become upset that you all don’t get to see him unless things have departed from an optimal path. So he has snuck into other parts of the CDRH Portal; If you look around in Portal help articles, you may just spot him in one of his poses.

As always, once you log in to the Portal, you can visit Portal Help (the ? icon found in the lower left corner of the Portal) “What’s new?” section to find out what was added in each release and to find answers to the most common questions.

[/fusion_text][fusion_imageframe image_id=”17308|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”FDA Regulatory Update – CDRH Portal Deployment – Help – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” magnify_full_img=”” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2023/12/FDA-Regulatory-Update-CDRH-Portal-Deployment-Help-Celegence.jpg[/fusion_imageframe][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

We hope that you find the CDRH Portal to be useful and user friendly. If you have questions not covered in Portal Help or have feedback on the Portal, please reach out to ccp@fda.hhs.gov.

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