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Human Drugs

Oramed Shelves Diabetes Drug After Phase 3 Miss

Oramed Pharmaceuticals discontinues clinical development of its Type 2 diabetes drug ORMD-0801 after a Phase 3 clinical trial missed its primary and s...

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Federal Register

Photobiomodulation Device 510(k) Submission Guide

Federal Register notice: FDA releases a draft guidance entitled Photobiomodulation (PBM) Devices Premarket Notification [510(k)] Submissions.

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Human Drugs

Swiss-FDA Mutual Recognition Agreement

FDA signs a good pharmaceutical manufacturing practice mutual recognition agreement with Switzerland and its regulatory agencies.

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Medical Devices

Implementing Cybersecurity Provision in Spending Bill

CDRHs Suzanne Schwartz says FDA is glad it now has the legal authority to require medical device manufacturers to address cybersecurity issues in thei...

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Medical Devices

NCVHS Should Add UDIs to Claims Forms: Article

Researchers call on the National Committee on Vital and Health Statistics to approve a proposal to add medical device unique identifiers to health sys...

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Biologics

Biocon Complete Response Letter on Insulin Biosimilar

FDA issues Biocon Biologics a complete response letter on its BLA for a biosimilar version of insulin aspart, citing additional data being needed and ...

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Biologics

Physicians Seek Panel Review for Full Approval of Alzheimers Drug

Physician advocacy group Doctors for America urges FDA to commit to convening an advisory committee meeting when it is time to consider the full appro...

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Medical Devices

2 Olympus Endoscope Warning Letters

FDA warns two Olympus endoscope and reprocessor manufacturing facilities about Quality System and Medical Device Reporting regulation violations.

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Human Drugs

PhRMA Expresses ICH Q12 Guidance Concerns

Pharmaceutical Research and Manufacturers of America raises some issues with the International Conference on Harmonization Q12 guidance published by F...

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Medical Devices

Guide on 510(k) Submissions for Photobiomodulation Devices

FDA posts a draft guidance entitled Photobiomodulation (PBM) Devices Premarket Notification 510(k) Submissions.