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Whistleblower Strikes Out in FDA Allegations

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U.S. special counsel Carolyn Lerner says HHS and FDA filed satisfactory reports in response to a whistleblowers allegations that F...

FDA Not a Barrier in Advancing Alzheimers Products: Ostroff

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FDA acting commissioner Stephen M. Ostroff tells an industry conference that the agency isnt a barrier in the lack of good treatme...

Guidance on AERS for Outsourcing Facilities

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Federal Register Notice: FDA releases a final guidance on adverse event reporting for outsourcing facilities.

FDA to Rename Pediatric Cribs

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Federal Register Proposed rule: FDA proposes to rename pediatric hospital beds as pediatric medical cribs and establish special co...

FDA Justifies Decision Not to Contraindicate Corticosteroids

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FDA dismisses a 2014 advisory committee recommendation to add a contraindication or warning focused on cervical transforaminal inj...

FDA Accepts Vertex sNDA for Kalydeco

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FDA accepts a Vertex Pharmaceuticals supplemental NDA for the use of Kalydeco (ivacaftor) in patients eople with cystic fibrosis a...

FDA Denies Part of Phthalates Petition

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FDAs Center for Food Safety and Applied Nutrition denies a portion of a citizen petition seeking a regulation banning use of phtha...

FDA Helps Find Enzyme Controller

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Scientists from FDAs National Center for Toxicological Research and two other entities say they have found a microRNA that control...

FDA Cautions Against Incorrect Allergenic Nomenclature

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CBER cautions six companies about failing to use correct and consistent nomenclature on their licensed non-standardized allergenic...

Califf Took Name Off Articles Critical of FDA

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The Boston Globe reports that FDA commissioner-nominee Robert Califf asked that his name be removed from a series of journal artic...