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Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (from Catapult’s regulatory round-up for september 2023)

The FDA has issued a draft guidance to provide recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants relating to the development and review of drug or biological drug products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research 20 (CBER). This guidance discusses the principles of good meeting management practices as well as the standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings.

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


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (20 mai 2024). Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (from Catapult’s regulatory round-up for september 2023). ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/11osv


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