Pre-ANDA Program Overview (2of39) Complex Generics 2018

Lei Zhang from the Office of Generic Drugs provides an overview of the pre-ANDA program to include research, guidance (product-specific guidance), Pre-ANDA Meeting, and controlled correspondence.
_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Phone: [phone] I [phone]