Manufacturing Process and Controls (25/28) Generic Drugs Forum 2017 скачать в хорошем качестве

Manufacturing Process and Controls (25/28) Generic Drugs Forum 2017

Nallaperumal Chidambaram, CDER Office of Pharmaceutical Quality, highlights with case studies, how to avoid common review issues that could potentially turn into a major deficiency/approvability issue. He also shares recommendations for a first cycle approval. _______________________________ 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: CDERSBIA@fda.hhs.gov Phone: (301) 796-6707 I (866) 405-5367