Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.

The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...

The mHealth Regulatory Coalition (MRC) recently released “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth," which is a 60-page paper that focuses on two fundamental ...

WASHINGTON (AP) — The Trump administration said Tuesday it will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else — raising questions ...

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies ...

Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...

‘The beauty and longevity revolution demands both breakthrough science and the infrastructure to deliver it,’ according to Geltor CEO. ‘PrimaColl is the first ingredient to nail both’ California ...

The FDA has accepted a biologics license application from Inovio for a potential treatment for adults with recurrent respiratory papillomatosis. Although the application was filed under the ...

Oobli secured its third FDA “no questions” letter, acknowledging the company’s assessment that brazzein-54 is Generally Recognized as Safe (GRAS) for use as a sweetener in foods and beverages, and ...

The agency is currently reviewing the study findings ...

Onego Bio, a food ingredient company producing egg protein through precision fermentation, announced today that the U.S. Food and Drug Administration (FDA) has issued a “no questions” letter regarding ...