Journal of Developing Drugs
Open Access

A regulatory update on the US generic drug review and approval process following the implementation of 2012 generic drug user fee law

International Conference and Expo on Generic Drug Market & Contract Manufacturing

November 07-09, 2016 Barcelona, Spain

Duu Gong Wu

PPD Regulatory Consulting, USA

Posters & Accepted Abstracts: J Develop Drugs

Abstract :

It has been three years since the implementation of Generic Drug User Fee Amendment in US. Significant changes associated with a complete Over Half of generic drug review and approval process has since been implemented. Meanwhile, FDA has published many guidance documents to deal with filing and review procedures, organization of ANDA submission, and scientific requirements such as those for stability and impurities. At the same time, the formation of Office of Pharmaceutical Quality (OPQ) combined the quality reviews of new drugs, biotechnology products and generic drugs (Life Cycle Products) under a single organization and incorporated the manufacturing sciences and product surveillance into the review system. These changes under the concept of risk-based CMC reviews and GMP inspections and life cycle management present certain challenges to a generic drug company which plans to enter US generic market. The presentation will detail the changes implemented in the last three years and discuss their implications and common issues regarding how to prepare a good ANDA application.