FDA To Strengthen Generic Drug Program...Streamline Generic Drug Approval Process
 

FDA To Strengthen Generic Drug Program Which Will Streamline Generic Drug Approval Process

05 Oct 2007

The US Food and Drug Administration (FDA) will bolster its generic drug program which should raise the number and range of generic drugs available to health care providers and consumers. Generic drugs tend to be cheaper than brand name drugs - fierce competition among generic makers has helped bring prices down, explains the FDA.

The Generic Initiative for Value and Efficiency (GIVE) is aimed at streamlining and modernizing the FDA's generic drug approval business. According to the Agency, during fiscal year 2007, 682 generic drugs were approved, 30% more than during fiscal year 2006.

Gary Buehler, Director, Office of Generic Drugs, FDA, said "To keep pace with the increasing number of generic drug applications, FDA will implement some changes to the generic drug approval process. The GIVE plan outlines ways to maximize the use of our resources so that FDA can review and approve even more high quality generic drugs during the upcoming fiscal year than it did in 2007."

The FDA said it is improve the review order for some specific drug applications. For example, first generic drugs, for which there are no blocking patents or exclusivity protections on the reference listed drug, will be placed in the fast review ("expedited review") category. In other words, drugs for which there are no generic products on the market will reach the market earlier.

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