GENERIC DRUG USER FEE: AN OVERVIEWAbstract
The globalization of generic drug manufacturing, supply and testing, and a growing workload that has far outpaced USFDA’s resources has created new challenges. USFDA & Industry propose generic drug user fee to address the need for globalization of the inspection process, and to speed the timely review of generic product applications. The Generic Drug User Fee (GDUF) proposal is agreed by generic industry & USFDA and is focused on three key aims: safety, access, and transparency. Under the program, USFDA will receive nearly $1.5 billion over five years in supplemental funding through generic industry user fees in order to help the agency expedite access to generic drugs, enhance drug quality and safety and ensure inspection parity of both foreign and domestic manufacturing sites. GDUF also will help accelerate the market entry of additional manufacturers of drugs currently in short supply and improve quality, consistency, and availability within the supply chain, further helping to mitigate drug shortages. The GDUF new legislation is a milestone for the generic giants and a major win for American health care consumers.
Darshit S. Patel*, Abhishek R. Patel and Narendra A. Patel
Astron Research Limited, Ahmedabad, Gujarat, India
22 June, 2012
30 July, 2012
22 August, 2012
01 September, 2012