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MDMA Suggests Changes to Cybersecurity Guidance

[ Price : $8.95]

The Medical Device Manufacturers Association requests changes to several aspects of an FDA draft guidance on premarket cybersecuri...

Subcutaneous Opdivo User Fee Date Shortened

[ Price : $8.95]

FDA revises its user fee review action date from 2/28/2025 to 12/29/2024 for a Bristol Myers Squibb BLA for a subcutaneous formula...

AdvaMed Seeks More Efficient Feedback Requests

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The Advanced Medical Technology Association says FDAs new draft guidance on Requests for Feedback and Meetings for Medical Device ...

Ultrasound Devices for Glaucoma Reclassified

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Federal Register notice: FDA issues a final order reclassifying the ultrasound cyclodestructive device, a postamendments Class 3 d...

CVM Policy on Foods with Drug Claims Withdrawn

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Federal Register notice: FDA announces the withdrawal of the Center for Veterinary Medicines Program Policy and Procedures Manual ...

2 Interchangeable Eylea Biosimilars Approved

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FDA approves two BLAs for interchangeable biosimilars to Regenerons Eylea (aflibercept) Biocon Biologics Yesafili (aflibercept-jb...

Meditrina 2nd Gen Hysteroscopy System Cleared

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FDA clears a Meditrina 510(k) for its second generation bipolar radiofrequency Aveta Glo hysteroscopy system.

FDA Discusses Future of Clinical Research

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FDA chief medical officer Hilary Marston discusses the future of clinical research and new initiatives to support clinical trial i...

Hold Removed on Friedreichs Ataxia Therapy

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FDA removes a partial clinical hold on Larimar Therapeutics nomlabofusp (CTI-1601), which is being evaluated for treating patients...