In any review of mifepristone, the FDA will now have to grapple with Judge Otake’s conclusion that the 2023 REMS decision for ...

This is an archived article and the information in the article may be outdated. Please look at the time stamp on the story to see when it was last updated. MINERVA, Ohio (WJW) – A local company has ...

Senators cite study showing 22 times higher serious side effects from chemical abortion drugs than FDA labels indicate, ...

The ANSI-ASQ National Accreditation Board (ANAB) recently notified the US Food and Drug Administration that LSQA SA of Montevideo, Uruguay now is accredited as a certification body (CB) by ANAB under ...

According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...

On January 3, 2023, FDA released an updated Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. The updated REMS follows a December 2021 FDA announcement that it would eliminate the ...

WASHINGTON — Drug testing facilities that have invested in oral-fluid-based testing for motor carriers, airlines, railroads and pipeline operators are pushing back on a proposal by the U.S. Department ...

OnePlus is looking for FDA approval for its Sleep Apnea detection feature The OnePlus Watch 3 launched without FDA ...

Three Democratic senators are requesting additional information about the FDA’s Pre-Cert for Software Pilot Program, a streamlined regulatory pathway for digital health technologies that the agency ...

Dr. Harvey Karp nearly announced last summer that the FDA certified that Snoo reduces SIDS. But FDA approval of the $1,700 high-tech crib never came — and month's later is still missing. Experts say ...