Скачать или смотреть eDRLS 2024 | D1S05-1 - CDER Direct Drug Listing

This presentation demonstrated creating a listing SPL through CDER Direct and enumerated data elements required for drug listing. The session explained timing requirements for initial drug listing to FDA. The discussion provided practical guidance for completing drug listing obligations and understanding regulatory deadlines for submission compliance.

Timestamps

00:26 – “Who”

01:17 – “What”

02:19 – “When”

03:21 – Live Demonstration

20:10 – Summary

20:45 – Drug Listing Do’s and Don’ts

Speaker:

Troy Cu
Technical Information Specialist
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration, and Unapproved Drugs (DLRUD)
Office of Unapproved Drugs & Labeling Compliance (OUDLC)
Center for Drug Evaluation and Research (CDER) | FDA

Learn more at: https://www.fda.gov/drugs/news-events...

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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