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Woodside Acquisitions Covid Test Recall is Class 1

[ Price : $8.95]

FDA says a Woodside Acquisitions recall of some 51,000 unapproved Covid-19 antigen tests is Class 1.

FDA Clears CTL Amedica Pedicle Screw Navigator

[ Price : $8.95]

FDA clears a CTL Amedica 510(k) to market the CTL Amedica Navigation Instrument System for use in pedicle screw preparation and pl...

FDA Denies Part of Contraceptive Study Group Petition

[ Price : $8.95]

FDA denies a portion of a 2019 petition asking for a Boxed Warning on breast cancer risk for combined hormonal contraceptives.

AI Has Usefulness for Pharmacovigilance: Report

[ Price : $8.95]

CDER Office of Surveillance and Epidemiology executives discuss the potential use of artificial intelligence in pharmacovigilance ...

Oryx Dental Imaging Integrator Cleared

[ Price : $8.95]

FDA clears an Oryx Dental 510(k) for its imaging product, Oryx Imaging that allows health professionals to acquire, view, annotate...

FDA Clears CTL Amedica Pedicle Screw Navigator

[ Price : $8.95]

FDA clears a CTL Amedica 510(k) to market the CTL Amedica Navigation Instrument System for use in pedicle screw preparation and pl...

Label Safety Considerations Guidance

[ Price : $8.95]

FDA publishes a guidance with principles and recommendations to ensure that critical elements of a products container label and ca...

House Commerce Committee Moves User Fee Bill to Floor Vote

[ Price : $8.95]

The House Energy and Commerce Committee unanimously votes (55 to 0) to advance the Food and Drug Amendments of 2022, bipartisan le...

Science Board to Discuss Cannabinoids, Animal Studies

[ Price : $8.95]

FDA schedules its Science Board to the Food and Drug Administration Advisory Committee to consider challenges in evaluating the sa...

DoJ Sues Prometheus Over Device Use

[ Price : $8.95]

The Justice Department sues The Prometheus Group and its owner for allegedly recommending that single-use medical devices be used ...