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How To Guide Your Client's New Drug Past An FDA Quick Kill

Law360 (March 5, 2018, 4:06 PM EST) -- Celgene Corp. took a hit last week when the company said the U.S. Food and Drug Administration wouldn't even consider its new drug application for its top-pipeline multiple sclerosis drug.

Receiving a so-called refuse to file letter from the FDA is an uncommon but not unheard of hurdle that branded-drug companies can face. The company will have the chance to review their errors and try again, meaning the work wasn't for naught, but the fixes range in severity from needing to provide forgotten data to conducting...
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