Рет қаралды 3,084
CDER’s Jonathan Resnick discusses CDER’s NextGen Portal which is designed to allow a sponsor who normally submits in paper to easily transmit an electronic version instead. Resnick discusses the different submission mechanisms (ESG, CDER NextGen Portal, CDER Direct) to submit to CDER, when to use and when not to use CDER NextGen Portal (i.e., eCTD vs non-eCTD, CDER Submission vs CBER Submission), how to register an account on the CDER NextGen Portal.
_______________________________
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/cd...
CDER SBIA 2020 Playlist: • 2020 CDER Small Busine...
LinkedIn: / cder-small-business-an...
Training resources: www.fda.gov/cd...
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.go...
Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367