FDA expects to issue guidance on policies regarding generative AI devices, according to Rick Abramson, the agency’s head of ...

On June 24, 2026, the U.S. Food and Drug Administration (FDA) released a draft update to its 2019 draft guidance titled “Demonstrating ...

The US Food and Drug Administration (FDA) on Wednesday finalized guidance addressing frequently asked questions related to ...

Aug 11 (Reuters) - The U.S. Food and Drug Administration on Tuesday finalized guidance for companies that prepare and package fresh fruits and vegetables to reduce the risk of foodborne illness. The ...

On June 25, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of revised draft guidance titled “Demonstrating ...

Center for Biologics Evaluation and Research (CBER) has issued a guidance to assist sponsors in assessing potency assays for ...

The FDA panel is reviewing seven peptides and deciding if they should be added to a list of substances that can be safely produced by compounding pharmacies.

FDA has moved artificial intelligence (AI) in medical devices from an exploratory concept to operational expectations, finalizing a pathway to pre-approved algorithm updates (PCCPs), publishing ...

FDA’s recently unveiled 2025 Human Foods Program guidance agenda offers a detailed view of the agency’s priorities for the year ahead. The document is non-binding, but provides critical insight into ...

The 2026 proposal is seemingly shifting the TRT landscape, moving it further from the “use with caution” territory.

Medical device manufacturers developing digital health products face a recurring question: Will the U.S. Food and Drug Administration (FDA) regulate this product? Many digital health products can ...

The Trump administration is preparing to roll out new dietary guidelines for Americans in early January, a move Food and Drug Administration (FDA) officials say will kick off a broader food policy ...