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Cadila Healthcare CGMP Violations

[ Price : $8.95]

FDA warns Indias Cadila Healthcare about CGMP violations in its manufacturing of finished pharmaceuticals.

BD PMA Supplement to Expand HPV Assay

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Becton Dickinson files a PMA supplement for an expanded version of its BD Onclarity HPV Assay.

FDA OKs Hologics 3DQuorum Imaging Technology

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FDA approves a Hologic PMA for its 3DQuorum Imaging Technology for use with the companys Clarity HD high resolution imaging techno...

Panel Urges Risk-based Sterility Assurance for Devices

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Worried about device shortages that could occur from recent closures of facilities that use ethylene oxide to sterilize medical de...

3 IMDRF Clinical Documents Published

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The International Medical Device Regulators Forum issues three final guidances relating to clinical evaluation, clinical evidence,...

FDA Reports New Vascepa Safety Concerns

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FDA medical reviewers ask the Endocrinologic and Metabolic Diseases Advisory Committee to discuss efficacy and safety information ...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes MSM Nutraceuticals, Cadila Healthcare and Swabplus.

Potential Dietary Supplement Statutory Changes

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FDA principal deputy commissioner Lloyd Schiller says the agency is looking at changes to the Dietary Supplement Health and Educat...

FDA Clinical Hold for Solid Biosciences Duchenne Trial

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FDA places a Solid Biosciences Phase 1/2 trial of its SGT-001 Duchenne muscular dystrophy drug on clinical hold.

F2G Gains Breakthrough for Olorofim in Mold Infections

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FDA grants F2G Ltd. a breakthrough therapy designation for olorofim for treating invasive mold infections in patients with limited...