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Published on 8 October 2007

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FDA to speed up generic drug review process


The FDA has announced it is to change the way generic drugs are approved in order to address a backlog of more than a thousand applications.

FDA officials outlined a host of changes that they said will streamline how the agency processes applications for cheaper versions of branded drugs.

The organisation said it will start processing applications for generic drugs that have just lost patent protection. Previously, priority was given to applications for drugs that might still be patented for years.

Other changes include reviewing multiple applications for the same product at the same time and urging companies to submit more information using the Internet.

Generic drug submissions to the FDA have more than doubled over the last five years, and the agency approved a record 682 generics in 2007.

However, 1,300 applications are still waiting to be reviewed.

The organisation said it is looking to hire additional staff to help its 215 employees who already review generic applications.

However, whether the FDA has sufficient funds to hire new reviewers will depend on whether Congress approves the agency’s budget request later this year.

Copyright © PA Business 2007


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