Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...
Add Yahoo as a preferred source to see more of our stories on Google. FDA commissioner Marty Makary made the announcement during the 2026 CES trade show The US Food and Drug Administration (FDA) is ...
The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...
On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...
In 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a surprising number of enforcement letters to ...
Recently, the U.S. Food and Drug Administration (FDA) issued a guidance document entitled Use of Real-World Evidence to Support ...
In December, the FDA granted breakthrough status for an implantable kidney replacement system for patients with end-stage kidney disease, according to a company press release.The Holly device by ...
M4Q (R2) is a globally harmonized framework for structuring quality information in medicinal product registration ...
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