NDA and BLA Application Review Process (6of15) REdI Annual Conference - May 29-30, 2019
Вставка
- Опубліковано 10 вер 2024
- Lois Almoza from CDER’s Office of New Drugs discusses the application review process. She covers the timeline for an application, end of review actions and their implications, and best practices to make an application as complete as possible.
Learn more at www.fda.gov/dr...
_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Visit www.fda.gov/cd... and www.fda.gov/cd... for news and a repository of training activities.
Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
LinkedIn: / cder-small-business-an...
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.go...