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.
_______________________________
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: www.fda.gov/cd...
CDER SBIA 2020 Playlist: • 2020 CDER Small Busine...
LinkedIn: / cder-small-business-an...
Training resources: www.fda.gov/cd...
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.go...
Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
6 окт 2024
