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FDA Approves Clozapine REMS Changes

[ Price : $8.95]

FDA posts upcoming changes to the clozapine REMS (risk evaluation and mitigation strategy).

Patient Engagement and Regenerative Medicine Summary

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FDA releases the transcript from a 5/6 CBER virtual workshop on patient engagement and regenerative medicine.

Volpara Health 510(k) for Updated Breast Assessment

[ Price : $8.95]

FDA clears a Volpara Health 510(k) for the latest version of its key science algorithm, Volpara Imaging Software (VIS 3.2), a brea...

Genentech BLA for Faricimab for Eye Disorders

[ Price : $8.95]

FDA accepts for a priority review a Genentech BLA for faricimab for treating wet, or neovascular, age-related macular degeneration...

Many Reports of Medical Device Deaths Misclassified: Study

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Researchers say many reporters to the FDA MAUDE medical device database misclassify deaths in other categories.

ICH Drug Continuous Mfg. Guidance Open for Comment

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The International Council for Harmonization says its Q13 guidance on drug continuous manufacturing is available for public comment...

FY 2022 Generic Drug User Fee Rates

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Federal Register notice: FDA announces the generic drug user fee rates for fiscal year FY 2022.

Debarment Order Against Justin Ash

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Federal Register notice: FDA issues a five-year debarment order against Justin Ash due to his felony conviction for illegal import...

Developing Rabies Monoclonal Antibody Cocktail Guidance

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FDA issues a draft guidance to help sponsors develop anti-rabies virus monoclonal antibody cocktails.

FDA Clears 2 Medtronic AccuRhythm AI Algorithms

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FDA clears two Medtronic AccuRhythm artificial intelligence algorithms for use with the LINQ II insertable cardiac monitor.