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Medical Devices

Dental Bone Graft Animal Study Guide

FDA publishes a draft guidance to help with animal studies for dental bone grafting devices submitted with a 510(k).

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Human Drugs

2 REMS Assessment MAPPs

CDER publishes two MAPPs on elements of REMS assessments.

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Medical Devices

FDA Fails to Follow Science in Electroshock Case: Attorneys

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

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Biologics

BIO Suggestions for CGT Potency Guidance

The Biotechnology Innovation Organization suggests ways FDA can improve a draft guidance on potency assurance for cellular and gene therapy products.

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Human Drugs

Catalent Indiana FDA-483

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

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Human Drugs

Merck BLA for Winrevair Approved

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

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Federal Register

Proposed Ban on Certain e-Stimulation Devices

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

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Federal Register

Guidance on Bioequivalence Testing Samples

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

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FDA General

Weiner Moves to Foreign Inspections Office

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

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Medical Devices

Boston Scientific Recalls PolarSheath Steerable

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