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FDA’s recent draft guidance, Regulatory Considerations for Prescription Drug Use Related Software, proposes a regulatory framework for software disseminated by a drug sponsor that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 ...
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 ...
The FDA Friday issued a draft guidance to clarify what establishments and types of food are covered by the menu labeling rule, how to determine calorie counts, and how and where calorie counts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 ...