CDER’s Maureen Dillon-Parker and Judit Milstein discuss the content and format of an initial IND submission and what to expect during the first 30 days, including processes for clinical holds and best practices.
_______________________________
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: www.fda.gov/cdersbia
CDER SBIA 2018 Playlist: • 2018 CDER Small Busine...
LinkedIn: / cder-small-business-an...
Training resources: www.fda.gov/cderbsbialearn
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.gov/subscriptionm...
Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
14 май 2020
