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Medical Devices

Comments on Increasing Home Medical Tech Use

Five stakeholders respond to FDA docket questions about expanding home medical technology use.

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FDA Renews 5-Year M-CERSI Agreement

FDA approves a five-year $50 million contract renewal with the University of Maryland Center of Excellence in Regulatory Science and Innovation.

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Human Drugs

Aion Bio Temperature Monitor Cleared

FDA clears an Aion Biosystems 510 (k) for its iTempShield device and software system for continuous measurement of body temperature.

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Biologics

Abeona Plans BLA for Cell Therapy

Abeona Therapeutics plans to file a BLA for EB-101, a cell therapy for patients with recessive dystrophic epidermolysis bullosa, after a pre-BLA meeti...

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Medical Devices

Breakthrough Designation for Quest Diagnostic

FDA grants Quest Diagnostics a breakthrough device designation for its AAVrh74 ELISA assay for identifying Duchenne muscular dystrophy patients eligib...

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Human Drugs

RAISE Program Explained

Reagan-Udall Foundation director of research Carla Rodriguez explains the RAISE program that is helping to collect, curate, and integrate race and eth...

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Human Drugs

CGMP Violations at K.C. Pharmaceuticals

FDA warns Pomona, CA-based K.C. Pharmaceuticals about CGMP violations in its production of finished drugs.

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Human Drugs

Gadal Laboratories CGMP Violations

FDA warns Miami, FL-based Gadal Laboratories about CGMP violations in its production of finished drugs.

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Medical Devices

Tesla BioHealing Illegally Marketing Devices

FDA warns Milford, DE-based Tesla BioHealing about illegally marketing adulterated and misbranded medical devices.

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Human Drugs

Janssen Seeks Full Approval for Balversa

Janssen Pharmaceutical files a supplemental NDA that is seeking to convert Balversas (erdafitinib) 2019 accelerated approval to full approval for trea...