Looking to clarify its expectations on manufacturer responses following inspections, the FDA earlier this year unveiled, for ...

WASHINGTON -- The US Food and Drug Administration said Wednesday it will be lowering its targets for sodium content in processed, packaged, and prepared foods, but not to levels recommended for ...

The FDA has issued detailed guidance on decentralized clinical trials (DCTs), clarifying operational expectations for remote consent, telehealth, and data integrity, while AI and data science tools ...

The FDA has quietly proposed legislation that would give it more authority to deem drugs misbranded in pharma DTC ads. But ...

The FDA released draft guidance indicating it may approve certain biosimilars without requiring a comparative efficacy study (CES), traditionally a costly and time-intensive step. Instead, advances in ...

The U.S. Food and Drug Administration (FDA) issued new draft guidance on Sept. 20, 2025, surrounding expedited programs for regenerative medicine therapies for serious conditions. The draft guidance ...

MOLINE, Ill. — The Food and Drug Administration (FDA) has narrowed its guidelines on who should receive the updated COVID-19 vaccine. The changes mean fewer people are automatically eligible this year ...

WASHINGTON, D.C., USA — The U.S. Food and Drug Administration on Wednesday released 10 new guidelines for drug manufacturers to follow when using artificial intelligence to develop new treatments. The ...

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.

The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for ...

FDA authorizes an expanded access treatment protocol after the oral RAS(ON) inhibitor doubled survival for metastatic patients in a phase 3 trial.