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The FDA released draft guidance indicating it may approve certain biosimilars without requiring a comparative efficacy study (CES), traditionally a costly and time-intensive step.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The U.S. Food and Drug Administration (FDA) issued new draft guidance on Sept. 20, 2025, surrounding expedited programs for regenerative medicine therapies for serious conditions. The draft guidance ...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 ...

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 ...

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The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for ...

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

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

The Food and Drug Administration today announced it is accelerating regulatory action on a new class of psychedelic-based therapies, following an April 18 executive order calling to speed up access to ...