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Comments on Increasing Home Medical Tech Use

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

FDA Renews 5-Year M-CERSI Agreement

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

Aion Bio Temperature Monitor Cleared

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

Abeona Plans BLA for Cell Therapy

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

Breakthrough Designation for Quest Diagnostic

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

RAISE Program Explained

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

CGMP Violations at K.C. Pharmaceuticals

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

Gadal Laboratories CGMP Violations

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

Tesla BioHealing Illegally Marketing Devices

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

Janssen Seeks Full Approval for Balversa

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