FDA expects to issue guidance on policies regarding generative AI devices, according to Rick Abramson, the agency’s head of ...
The US Food and Drug Administration (FDA) on Wednesday finalized guidance addressing frequently asked questions related to ...
The US Food and Drug Administration (FDA) on Monday finalized guidance on its approach to making therapeutic equivalence (TE) ...
The FDA has published guidance with information for manufacturers and processors of ready-to-eat produce to help them comply ...
The starting point is federal law. The Tobacco Control Act generally prohibits the marketing of a new tobacco product without ...
On June 25, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of revised draft guidance titled “Demonstrating ...
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.
A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and ...
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 ...
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 ...
The FDA's draft guidance could streamline biosimilar approval by reducing the need for comparative efficacy studies, emphasizing analytical assessments instead. This approach may lower development ...
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