Decrease RTR, IR, and CR Due to Dissolution Deficiencies (21of28) GDF - Apr. 3-4, 2019

CDER Office of Pharmaceutical Quality Division of Biopharmaceutics’ Om Anand shares how to decrease Refuse to Receive (RTR), Information Request (IR), and Complete Response (CR) regulatory actions due to
dissolution deficiencies, and increase approval during first review cycle from a a biopharmaceutics perspective. He discusses FDA inadequate and adequate dissolution submissions. He covers ANDAs and RTR regulatory actions related to dissolution deficiencies, considerations for selection of dissolution method & criteria/criterion, common dissolution deficiencies, and future directions. A top RTR is due to inadequate dissolution.
Learn about
Learn more at www.fda.gov/dr...
_______________________________
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 www.fda.gov/cd... and www.fda.gov/cd... for news and a repository of training activities.
Email: [e-mail]
Phone: [phone] I [phone]
LinkedIn: / cder-small-business-an...
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.go...