Zhihao Peter Qiu, CDER Office of Pharmaceutical Quality, shares regulatory requirements for biological products submitted under Biologics License Applications (BLAs), CDER biotech pre-license and pre-approval inspections, and common deficiencies.
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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.
Upcoming training and free continuing education credits: [ Ссылка ]
CDER SBIA 2020 Playlist: [ Ссылка ]
LinkedIn: [ Ссылка ]
Training resources: [ Ссылка ]
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CDER small business e-mail update subscription: [ Ссылка ]
Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
