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FDA Orders Benzodiazepine Boxed Warning Change

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FDA says it is ordering labeling changes to benzodiazepines to highlight risks of abuse, misuse, addiction, withdrawal symptoms, e...

FDA Accepts Pfizer sNDA for Xalkori Indication

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FDA grants priority review for Pfizers Xalkori sNDA to treat some pediatric lymphoma patients.

Hahn Testifies to Reassure FDA Independence with Covid-19

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FDA commissioner Stephen Hahn testifies on Capitol Hill to reassure lawmakers and the public that a transparent science- and data-...

Prexxartan Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Carmel Biosciences Prexxartan (valsartan) oral solution was not withdrawn due to safe...

Hahn and CDCs Redfield Dismiss Deep State Concerns

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FDA commissioner Stephen Hahn and CDC director Robert Redfield dismiss notions that a deep state operates within their agencies in...

Coupler Enterprises CGMP Inspection Violations

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FDA warns Coupler Enterprises about CGMP violations in its manufacturing of finished drugs.

FDA Amending Medical Product Intended Use Regs

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FDA says it will update regulations to clarify the types of evidence it considers when determining the intended use of a medical p...

Draft Guide on Cannabidiol Bioequivalence

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Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance for Cannabidiol.

Meeting on Sex and Gender Differences with CBD

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Federal Register notice: FDA announces an 11/19 public meeting Webcast entitled CBD and Other Cannabinoids: Sex and Gender Differe...

Safety Alert on Perrigo Albuterol Inhalers

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FDA alerts health care professionals and patients to a recall of all unexpired albuterol sulfate inhalation aerosol manufactured b...