Скачать с ютуб Preparing for GDUFA II User Fees (6/28) Generic Drugs Forum 2017 в хорошем качестве

Preparing for GDUFA II User Fees (6/28) Generic Drugs Forum 2017

Donal Parks, CDER, provides an overview of the user fee structure under GDUFA II. He focuses on how the user fee structure under GDUFA II is different from that under GDUFA I, and details the efforts the FDA is making, in conjunction with regulated industry, to prepare for implementation on October 1, 2017. Parks pays special attention to the new ANDA Program Holder Fee and the Contract Manufacturing Operation fee. _______________________________ 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...   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