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Drug Substance Review - ANDA (22/28) Generic Drugs Forum 2017

Автор: U.S. Food and Drug Administration

Загружено: 2020-08-03

Просмотров: 594

Описание: Benjamin Lim, CDER Office of Pharmaceutical Quality, provides an overview of the drug substance review process of the ANDA submission. He also shares recommendations for submitting a substantially complete ANDA.
_______________________________
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 2017 Playlist:    • 2017 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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Drug Substance Review - ANDA (22/28) Generic Drugs Forum 2017

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