NDA and BLA Application Review Process (6of15) REdI Annual Conference – May 29-30, 2019
14.9 هزار بار بازدید -
5 سال پیش
-
Lois Almoza from CDER’s Office
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 https://www.fda.gov/drugs/cder-small-...
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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.
Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities.
Email: [email protected]
Phone: (301) 796-6707 I (866) 405-5367
LinkedIn: LinkedIn: cder-small-business-and-industry-assistance
Twitter: Twitter: FDA_Drug_Info
CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...
Learn more at https://www.fda.gov/drugs/cder-small-...
_______________________________
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 https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities.
Email: [email protected]
Phone: (301) 796-6707 I (866) 405-5367
LinkedIn: LinkedIn: cder-small-business-and-industry-assistance
Twitter: Twitter: FDA_Drug_Info
CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...
5 سال پیش
در تاریخ 1399/01/08 منتشر شده
است.
14,951
بـار بازدید شده