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Weiner Moves to Foreign Inspections Office

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FDA Office of Combination Products associate director for policy John Weiner moves to Office of Global Operations director, where ...

Boston Scientific Recalls PolarSheath Steerable

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Boston Scientific recalls the PolarSheath Steerable Sheath 12F after the company identified a tooling error in manufacturing which...

Magnetic Stimulation for Adolescent Depression Cleared

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FDA clears a Neuronetics 510(k) for its NeuroStar Advanced Therapy for use as an adjunct for treating major depressive disorder in...

FDA Approves Medtronic Evolut FX+

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FDA approves the latest version of Medtronics Evolut FX+ system to treat symptomatic severe aortic stenosis.

2 REMS Assessment MAPPs

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CDER publishes two MAPPs on elements of REMS assessments.

FDA Fails to Follow Science in Electroshock Case: Attorneys

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Two attorneys who represented the Canton, MA-based Judge Rotenberg Center in its court case against FDAs efforts to ban the use of...

BIO Suggestions for CGT Potency Guidance

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The Biotechnology Innovation Organization suggests ways FDA can improve a draft guidance on potency assurance for cellular and gen...

Catalent Indiana FDA-483

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FDA releases the form FDA-483 with six observations from an inspection at the Catalent Indiana drug manufacturing facility.

Merck BLA for Winrevair Approved

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FDA approves a Merck BLA for Winrevair (sotatercept-csrk) for injection for treating adults with pulmonary arterial hypertension.

Proposed Ban on Certain e-Stimulation Devices

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Federal Register proposed rule: FDA proposes to ban electrical stimulation devices intended for self-injurious behavior or aggress...