CDRH’s Kimberly Kontson and also CDER’s Quynh Nhu Nguyen offer a summary of human consider clinical items, human elements study at FDA, mix item factors to consider, as well as use design at CDRH.
FDA CDER’s Small Business and also Industry Assistance (SBIA) gives as well as informs aid in recognizing the regulative elements of human medication items & scientific study.
CDER SBIA 2018 Playlist: https://www.youtube.com/playlist?list=PLey4Qe-UxcxZvRWJ6dulyw1P5eQWWztz1
Educating sources: https://www.fda.gov/cderbsbialearn
Phone: (301) 796-6707 I (866) 405-5367
Upcoming training and also cost-free proceeding education and learning credit reports: https://www.fda.gov/cdersbia
CDER small company e-mail upgrade registration: https://updates.fda.gov/subscriptionmanagement