FDA Gives OK To Miss Some Drug Approval Deadlines

Law360, New York (March 11, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration is allowing reviewers to miss some deadlines for approving new drug applications by up to two months in an effort to cope with staffing shortfalls and a growing backlog of work.

“There is no policy change. This is an internal staff decision to deal with the workload,” Sandy Walsh, an FDA spokeswoman, said on Wednesday.

The decision to push back deadlines is being taken on a case-by-case basis, Walsh added. She would not comment on whether the agency has already...
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