An Inside Look: Formal Meetings Between PDUFA Product Sponsors or Applicants and the FDA On September 22, 2023, the FDA unveiled its draft guidance document, "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products”. Scope and Applicability: This guidance provides recommendations to industry on formal meetings between the FDA
FDA Issues Guidance for Industry on Biosimilar Labeling Stay Informed, Stay Prepared The FDA is charting the course for the future of biosimilars with its recent release. On September 15, 2023, the FDA unveiled its draft guidance document, "Labeling for Biosimilar and Interchangeable Biosimilar Products," along with a Notice of Availability (NOA).
FDA Finalizes Guidelines on Dose Banding for Ready-to-Use Containers The U.S. Food and Drug Administration (FDA) has recently issued a new guideline titled "Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — “Dose Banding” Guidance for Industry” and was recently
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