FDA Submits Final Proposals for PDUFA IV

March 30, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Rockville, MD (Mar. 23)-The US Food and Drug Administration has submitted to Congress its final proposals for reauthorizing the fourth Prescription Drug User Fee Act (PDUFA IV), which will follow the expiration of the current user-fee on September 30, 2007.

Rockville, MD (Mar. 23)-The US Food and Drug Administration (FDA, www.fda.gov) submitted to Congress its final proposals for reauthorizing the fourth Prescription Drug User Fee Act (PDUFA IV), which will follow the expiration of the current user fee on September 30, 2007. The law provides user-fee funds paid by brand drug and biotechnology companies that help support the review of new drugs.

According to an FDA release, annual user fees under PDUFA IV would increase to $392.8 million, an $87.4 million increase over PDUFA III.

The funds would support “key goals,” including enhancing premarket review and creating a modern postmarket drug safety system that follows products across their full life cycle.

“Our proposed recommendations for PDUFA IV aim to strengthen our drug safety system and upgrade resources to enhance FDA’s information technology capability,” said Commissioner of Food and Drugs Andrew C. von Eschenbach, MD.