Project Summary
The mission of CRCG is to increase access to safe and effective generic drugs through enhanced infrastructure/communication, education, and research collaboration across industry, academia, and the FDA. This research focuses on identify training and research activities that will promote the understanding of complex drug products, and hence the development of new complex generic drug products. To obtain these insights, the CRCG is conducting a “Research Survey of Scientific Challenges and Opportunities in the Development of Complex Generics”. The main areas of questioning are directed toward scientific/technical, regulatory and business/legal challenges and opportunities in complex generic drug development. This research also aims to understand the product portfolio of companies developing generic drugs and future considerations and opportunities in complex generic drug development.