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Digital Health Technologies Capture Real-Time Info: Column

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FDA Digital Health Center of Excellence director Rick Abramson outlines an agency white paper on developing and using digitally de...

Medline Convenience Kit Recall is Class 1

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Medline issues a device correction (Class 1 recall) for convenience kits containing B. Brauns bupivacaine hydrochloride components...

Profound Validation Gap in AI Medical Devices: Study

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Academic researchers worldwide say FDA and other regulators must approve artificial intelligence/machine learning-enabled devices ...

FDA OKs Regeneron Therapy for Fibrodysplasia Ossificans Progressiva

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FDA approves Regnerons Pasatru (garetosmab-grts) for reducing new heterotopic ossification (bone formation outside the skeleton) i...

Draft Guidance on Potency Testing for Active Immunotherapy Products

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FDA releases a draft guidance that outlines recommendations for developing potency assays for active immunotherapy products, inclu...

Repeat CGMP Violations at K.C. Pharmaceuticals

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FDA warns Pomona, CA-based K.C. Pharmaceuticals about repeat CGMP violations in the production of over-the-counter drugs.

Keytruda Melanoma Combination Trial Met Endpoints

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Merck and Moderna say a Phase 3 trial of Keytruda and intismeran autogene met key endpoints as an adjuvant melanoma treatment.

Auriga Research CGMP Violations

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FDA warns Indias Auriga Research contract testing laboratory about CGMP violations in its testing of drugs for clients.

Cellular, Gene Therapy Product FAQs

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FDA publishes a guidance with frequently asked questions on the development of cellular and gene therapy products.

FDA Authorizes First Standalone Robotic Device for Blood Draws

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FDA grants Vitestro a de novo authorization for Aletta, the first standalone robotic device designed to draw blood from a patients...