From the Bulletin of Health Policy and Law: FDA Generic Drug User Fee Proposal Aims to Enhance Safety, Access, and Transparency in the Generic Drug Market

http://www.bullhpl.org/resources/Publications/MasanqueRD.pdf

FDA Generic Drug User Fee Proposal Aims to Enhance Safety, Access, and Transparency in the Generic Drug MarketIsabel Masanque

Abstract: The FDA has established three goals in establishing the Generic Drug User Fee Act: (1) improve safety through consistent, high quality standards; (2) enhance access to low-cost generic drugs by expediting the review process and making the drugs available in the market faster; and (3) increase transparency by identifying facilities involved in the manufacture of generic drugs.


Published: 10 January 2013 Cite as: Masanque I. FDA Generic Drug User Fee Proposal Aims to Enhance Safety, Access, and Transparency in the Generic Job Market. Bull Health L Policy. 2012;1(2).