Скачать с ютуб NDA and BLA Application Review Process (6of15) REdI Annual Conference – May 29-30, 2019 в хорошем качестве

NDA and BLA Application Review Process (6of15) REdI Annual Conference – May 29-30, 2019

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-... _______________________________ 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:   / cder-small-business-and-industry-assistance   Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...