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 ...

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

The U.S. Food and Drug Administration (FDA) issued new draft guidance on Sept. 20, 2025, surrounding expedited programs for regenerative medicine therapies for serious conditions. The draft guidance ...

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The FDA released draft guidance indicating it may approve certain biosimilars without requiring a comparative efficacy study (CES), traditionally a costly and time-intensive step.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 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 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The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for ...

The FDA Process Validation training highlights opportunities in enhancing comprehension of constant process verification aligned with lifecycle concepts. It addresses early R&D phases through ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...