FDA Aims to Approve Record Number of Generics in Fiscal 2008
The FDA approved or tentatively approved a record 682 generic drugs in fiscal 2007, which was 33 percent more than the previous year, the agency announced.
The agency also unveiled a new umbrella policy to increase the number and variety of generic drugs. The Generic Initiative for Value and Efficiency (GIVE) program will help the agency modernize and streamline the generic drug approval process, the FDA said.
The agency said it plans to hire and train new generic drug reviewers and focus on enhanced use of electronic programs for handling drug submissions and internal documents.
The FDA also is revising the first-come, first-served review order for certain generic drug applications. For example, applications for first generic products for which there are no patent or exclusivity protections on the reference-listed drug will be moved to the front of the line.
The current backlog of generic applications hovers at approximately 1,300 applications, Gary Buehler, director of the FDA’s Office of Generic Drugs, said, but he noted that more than half of the drugs are still protected by patents or exclusivity and can’t be approved yet. The FDA first announced this plan to alter the review order a year ago.
More information on the FDA’s plan is available at www.fda.gov/oc/initiatives/advance/generics.html.
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