The generic drug submission process is the pathway for manufacturers to gain approval from regulatory authorities to market and sell a generic version of a previously approved branded drug by submitting an Abbreviated New Drug Application (ANDA) to the appropriate regulatory authority, such as the US Food and Drug Administration (FDA).. The ANDA must include data demonstrating the safety, efficacy, and quality of the generic drug.
This course provides a general overview of steps involved in the generics drug products submission in the U.S. and their regulatory framework. The course’s main focus is around the ANDA submission process as well as special considerations regarding generic’s patent certifications.
Learning Points:
- Introduction to Generics
- ANDA Submission Checklist
- Patents and Exclusivity for Generics
- ANDA special considerations
- Question Based Review for CMC Evaluation of ANDAs