FDA discusses a review perspective for early development IND submissions, with an emphasis on common missteps that can lead to clinical holds for CMC deficiencies and critical documentation for the original IND submission.
Presenters:
Paresma Patel, Ph.D., Acting Branch Chief, Division of New Drug API, CDER
Olen Stephens, Ph.D., Chemist, Division of New Products 1, Office of Pharmaceutical Quality, CDER
Learn more at: www.fda.gov/drugs/news-events...
--------------------
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 - www.fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accoun...
SBIA 2021 Playlist - • 2021 CDER Small Busine...
SBIA LinkedIn: / cder-small-business-an...
SBIA Training Resources - www.fda.gov/cdersbialearn
Twitter - / fda_drug_info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
14 апр 2021