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FDA Approves Medtronic Evolut FX+

[ Price : $8.95]

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The Biotechnology Innovation Organization suggests ways FDA can improve a draft guidance on potency assurance for cellular and gen...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

Guidance on Bioequivalence Testing Samples

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Federal Register notice: FDA makes available a guidance entitled Handling and Retention of BA and BE Testing Samples.

CGMP Violations at Deqing Jiarou

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FDA warns Chinas Deqing Jiarou Daily Chemical Co. about CGMP violations in its production of finished drugs.

Multiple Violations in ReNovo Inspection

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FDA warns Bend, OR-based ReNovo that its reprocessed single-use medical devices are adulterated and misbranded and have Quality Sy...