The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...
The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts ...
The FDA’s GRAS rule lets companies decide if food additives are safe—without agency oversight. RFK Jr. now aims to close this ...
The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, ...
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...
The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...
Two recent documents—one from the FDA, the other from a commission organized by The Lancet Diabetes & Endocrinology—indicate ...
Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.
Marty Makary, a career surgeon and President Trump’s nominee to run the Food and Drug Administration (FDA), faced senators in ...