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FDA Warns 17 Web Sites Illegally Selling Opioids

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FDA warns 17 Web site operators that they are illegally selling unapproved and misbranded opioids.

8 FDA Execs Say Agency is Following the Science

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The eight top FDA career executives write in a USA Today opinion piece that they are committed to following the science within the...

FDA Holds Up Sarepta Gene Therapy Trial

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FDA trepidation with gene therapies continues as it holds up a Sarepta Therapeutics clinical trial by asking for an additional pot...

FDA Approves sNDA for GSKs Trelegy Ellipta

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FDA approves a GlaxoSmithKline a supplemental NDA for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for treating a...

Return Drug Manufacturing to U.S.: Hahn, Shah

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FDA commissioner Stephen Hahn and associate commissioner Anand Shah say its time for investments and incentives to be added to FDA...

Minnetronix Medical MindsEye Expandable Port Cleared

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FDA clears a Minnetronix Medical 510(k) for the MindsEye Expandable Port for neurosurgical procedures.

Corrected Federal Register Notice on Right to Try

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Federal Register notice: FDA corrects a 7/24 notice on Annual Summary Reporting Requirements Under the Right to Try Act.

Covid-19 Guidances Open for Comments

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Federal Register notice: FDA makes available guidance documents related to Covid19 that have been implemented without prior commen...

Court Rejects Some Boehringer Ad Claims

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A Pennsylvania federal court orders Boehringer Ingelheim to stop using several promotional claims for its COPD medications.

Covid Vaccine Hold Should not Slow Development: Fauci

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National Institute of Allergy and Infectious Diseases director Anthony Fauci dismisses any notion that a reported serious adverse ...