Regulatory Highlights for Biosimilars and Interchangeables (9of15) REdI – May 29-30, 2019 скачать в хорошем качестве

Regulatory Highlights for Biosimilars and Interchangeables (9of15) REdI – May 29-30, 2019

Eva Temkin from CDER’s Office of New Drugs shares an overview of FDA’s perspective on the regulatory considerations applicable to development of biosimilar and interchangeable products under section 351(k) of the Public Health Service Act. She covers FDA’s biosimilars action plan, biological regulatory modernization, and recently-issued guidance including the updated draft guidance on nonproprietary naming of biological products. 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: CDERSBIA@fda.hhs.gov 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...