AGDD 2024 | D2S09 - Guidance for Industry: Content and Format of Composition Statement... скачать в хорошем качестве

AGDD 2024 | D2S09 - Guidance for Industry: Content and Format of Composition Statement...

This presentation described content and format requirements for composition statements of drug products and explained what to include in statements of ingredients in labeling. The session emphasized requirements for consistency in composition information across NDA and ANDA submissions. The discussion provided practical guidance for ensuring accurate and compliant composition documentation throughout the drug approval process. Timestamps 03:44 – What to Include in a Composition Statement? 07:43 – Specifics to Identify Ingredients in Composition Statement 11:52 – Specifics in Statement of Ingredients in Labeling 13:31 – Commonly Observed Issues in Composition Statement and Labeling 15:58 – Consistency in CMC Submissions 20:05 – Summary Speaker: Greg Huang, PhD Senior Chemist Division of Product Quality Assessment IX (DPQA IX) Office of Product Quality Assessment II (OPQA II) Learn more at: https://www.fda.gov/drugs/news-events... ----------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2024 Playlist -    • 2024 CDER Small Business and Industry Assi...   SBIA 2025 Playlist -    • 2025 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367