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FDA Overdue on 2,000 Drug Plant Inspections: AP

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An Associated Press analysis says FDA is overdue on some 2,000 drug company facilities that havent been inspected since before the...

Committee to Consider Iterum Sulopenem NDA

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FDA asks its Antimicrobial Drugs Advisory Committee whether an Iterum NDA for sulopenem etzadroxil/probenecid to treat some uncomp...

Group Seeks Clarity on Use-Related Risk Analyses

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Biosimilars Forum asks FDA for further information and clarification on certain areas of the agencys recent draft guidance entitle...

Drug Nitrosamine Impurity Control Guidance

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FDA publishes a revised guidance on controlling nitrosamine impurities in human drugs.

Baxter Recalls Volara Circuits, Adapter

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Baxter recalls (Class 1) certain Volara Single Patient Use Circuits and Blue Ventilator Adapter Assemblies due to reports that the...

Flagyl Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Pfizers Flagyl (metronidazole) tablets, 250mg and 500mg, were not withdrawn due to sa...

Comments on ICH RWD Studies Guidance

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Two industry associations give line-by-line comments and edits on an International Council for Harmonization draft guidance on the...

Labs Ask Court to Throw Out FDAs LDT Rule

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The American Clinical Laboratory Association and its fellow plaintiffs ask a Texas federal court to grant summary judgment in favo...

SoloVital Illegally Marketing Hyaluronic Acid: FDA

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FDA warns Chula Vista, CA-based SoloVital it is marketing a misbranded and unapproved hyaluronic acid drug product as a dietary su...

California Man Pleads Guilty to Illegal Etizolam Sales

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The Department of Justice says Californian Paul Lamberty pleaded guilty in a Massachusetts federal court to conspiracy to defraud ...