Filing and Refuse to Receive (RTR) (16of28) Generic Drugs Forum - Apr. 3-4, 2019

Varun Vasudeva and Phuong (Aiden) Nguyen from CDER’s Office of Generic Drugs, Division of Filing Review, answer the question, “What went wrong?” They cover the top reasons for RTRs and application deficiencies. Attendees will learn steps they can take to avoid these errors happening at their company.
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...