US FDA to speed up review of certain generic drugs
Wed Oct 18, 2006 9:16 AM ET
WASHINGTON, Oct 18 (Reuters) - Some generic drug applications now will be prioritized to receive faster six-month reviews from U.S. regulators, a top Food and Drug Administration official said on Wednesday.
Applications may undergo the expedited review if they are the first for a generic version of a drug no longer protected by a patent or market exclusivity, or if the medicine would address a public health emergency or nationwide shortage, said Dr. Steven Galson, director for FDA's Center for Drug Evaluation and Research.
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