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Medical Devices

DiA Imagings AI Imaging Software Cleared

FDA clears a DiA Imaging Analysis 510(k) for its LVivo IQS, a new artificial intelligence-based vendor-neutral software intended to help users in acqu...

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Medical Devices

Universal Meditech Recalls Covid Tests

Universal Meditech recalls (Class 1) its Skippack Medical Lab Covid-19 Direct Antigen Rapid Tests (Colloidal Gold) because they did not have FDA autho...

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FDA General

Califf Sails Through 1st Covid Oversight Hearing

FDA commissioner Robert Califf easily manages criticisms of the agencys handling of the Covid-19 pandemic during a 2/8 House Energy and Commerce joint...

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Biologics

Cell and Tissue Deviations at Palm Beach Fertility Center

FDA warns the Palm Beach Fertility Center about significant repeat deviations from cellular and tissue regulations.

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Medical Devices

FDA Criminal Probe Nets Device Maker Indictment

An FDA Office of Criminal Investigations probe leads to a Puerto Rico federal grand jury indictment against Magnetic Healer and three individuals char...

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Federal Register

Cell/Gene Therapy Advisory Committee Renewed

Federal Register notice: FDA announces the renewal of its Cellular, Tissue, and Gene Therapies Advisory Committee for an additional two years beyond i...

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FDA General

8 Inspection Takeaways from New FDA Law

Two former FDAers list eight key takeaways from the new FDA Omnibus Reform Act.

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Human Drugs

OCE Slowed New Projects in 2022

Oncology Center of Excellence director Richard Pazdur lists five activities for 2023 that build on steps taken in 2022.

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Human Drugs

Comments on FDA/Patent Office Collaboration

Four stakeholders respond to the patent offices request for comment on its proposed collaboration with FDA.

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Biologics

Kessler Praises Marks on Covid Response Leadership

CBER director Peter Marks gets high grades from former FDA commissioner and Biden administration Covid chief science officer David Kessler on Marks le...