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Supreme Court lets stand on Oct. 14 the April 16 D.C. federal appellate court decision denying Barr's petition to force FDA to complete ANDA reviews within 180 days. The latest decision was made without comment. The April decision stated that, although FDA's failure to review ANDAs in 180 days does violate a statutory limit, the court lacks the power to force FDA to process ANDAs within the deadline ("The Pink Sheet" April 22, p. 10)....
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