Overview of FDA's Expanded Access Program (13/14) REdI 2017 скачать в хорошем качестве

Overview of FDA's Expanded Access Program (13/14) REdI 2017

J. Paul Phillips provides an overview of the FDA’s expanded access program with a focus on investigational drug and biological products. The program’s role in providing patients treatment access to these products as well as the regulatory foundation for the program is discussed. The presentation identifies the types of expanded access requests and the criteria that must be met to allow authorization of those requests. ------------------------- 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: https://www.fda.gov/cdersbia CDER SBIA 2017 Playlist:    • 2017 CDER Small Business and Industry Assi...   LinkedIn:   / cder-small-business-and-industry-assistance   Training resources: https://www.fda.gov/cderbsbialearn Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm... Email: [email protected] Phone: (301) 796-6707 I (866) 405-5367