Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...

FDA’s recent draft guidance, Regulatory Considerations for Prescription Drug Use Related Software, proposes a regulatory framework for software disseminated by a drug sponsor that supplements or ...

The Food and Drug Administration is scrutinizing the common practice of giving coronavirus and flu shots together, signaling a reversal of years of federal guidance and a broader crackdown on ...

WASHINGTON (AP) — The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Donald Trump’s administration is causing alarm across the ...

The FDA Friday issued a draft guidance to clarify what establishments and types of food are covered by the menu labeling rule, how to determine calorie counts, and how and where calorie counts should ...

FDA continues to construct its regulatory program for cosmetic products, albeit at a slower pace than the congressional timelines provided in the Modernization of Cosmetics Regulation Act of 2022 ...

With states like California, Illinois, and New York questioning the safety of certain food additives and some other chemicals used in food, the public is wondering if a food is safe to eat if it ...

Please provide your email address to receive an email when new articles are posted on . Physicians had difficulty distinguishing GPT-4 responses from FDA responses about obesity medications. The ...

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...