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False, Misleading Claims in Sprout Addyi Radio Ad: OPDP

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FDA warns Sprout Pharmaceuticals about a violative radio ad for Addyi, indicated for women with low sexual desire.

CGMP Issues at Kalchem

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FDA warns Kalchem International about new and repeated CGMP violations and deviations in its production of finished drugs and APIs...

Vertex Wins Priority Review Voucher

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Federal Register notice: FDA issues a priority review voucher to Vertex Pharmaceutical for Trikafta (elexacaftor/tezacaftor/ivacaf...

Final Guide on Device Consensus Standards

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Federal Register notice: FDA makes available a final guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards...

Information Collections Approved by OMB

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Federal Register notice: FDA posts a list of information collections that have been approved by OMB under the Paperwork Reduction ...

Drug Labeling Geriatric Information Guidance

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FDA publishes a draft guidance with updated recommendations for including geriatric information in the labeling for prescription h...

CGMP Violations, Deviations at Mayons Pharmaceuticals

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FDA warns Indias Mayons Pharmaceuticals about CGMP issues in its manufacturing of finished drugs and APIs.

FDA, CDC Have Lost Bill Gates Trust

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Bill Gates says he no longer has trust in FDA and CDC as independent regulators because of the way they have responded to Trump ad...

Trust Down for FDA, Drug Companies: Poll

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Axios/Ipsos poll respondents say they have little faith in FDA or the drug industry to be looking out for the publics interests.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Kalchem International, Mayons Pharmaceuticals and Silkprousa.