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Generic Combination Products: Assessment and Regulatory Update (14of16) GDF 2020
Автор: U.S. Food and Drug Administration
Загружено: 2020-05-01
Просмотров: 4416
Описание:
Ashish Rastogi and Steven Hertz from the CDER Office of Pharmaceutical Quality (OPQ) discuss combination product assessments for ANDAs and provide a regulatory update.
Rastogi’s presentation aims to increase transparency in the regulatory process and help applicants understand FDA’s general expectations while preparing quality related sections of ANDA submission for combination products.
Hertz discusses the dynamic global regulatory environment and shares best-practices and lessons learned regarding combination product CGMP and PMSR requirements.
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 and free continuing education credits: https://www.fda.gov/cdersbia
CDER SBIA 2020 Playlist: • 2020 CDER Small Business and Industry Assi...
LinkedIn: / cder-small-business-and-industry-assistance
Training resources: https://www.fda.gov/cderbsbialearn
Twitter: / fda_drug_info
CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...
Email: [email protected]
Phone: (301) 796-6707 I (866) 405-5367
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