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Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry (from Catapult’s regulatory round-up for september 2023)

The FDA has announced the availability of a final guidance entitled “Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989” which is intended for applicants that are required to report annually on the status of postmarketing studies and clinical trials for human drug and biological products under section 506B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356b) and its implementing regulations at 21 CFR 314.81(b)(2)(vii) and 601.70. This guidance describes the purpose and content of Form FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics

Published on the 29th of september 2023. Read more of the regulatory round-up for september 2023 here.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (20 mai 2024). Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry (from Catapult’s regulatory round-up for september 2023). ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/11osu


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