The Commissioner’s National Priority Vouchers aim to offer accelerated pathways to drugs that meet certain criteria, perhaps ...

Master FDA expectations and best practices. Learn about facility design, personnel qualification, and contamination control, tackling FDA scrutiny and aligning with EU Annex 1 & ICH Q9/Q10 principles.

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

There’s no questioning that AI should have governance and guardrails. As much good as it can bring, it also heightens risk.

Explore the FDA’s 2025 Human Foods Program Guidance Agenda and what it means for US food and beverage businesses. Key ...

A major shift in U.S. food policy could affect your favorite snack's look, taste, and price—and your fingertips might never ...

The FDA has invited public comment on this draft guidance by April 7, 2025 and will be hosting a webinar on February 18, 2025, to discuss just this draft guidance on medical devices.

Additionally, FDA has scheduled a public webinar on the draft guidance on February 18, 2025. 1 FDA, Draft Guidance for Industry & FDA Staff, Artificial Intelligence-Enabled Device Software ...

FDA Commissioner Dr. Marty Makary joins Morning Joe to address the agency’s controversial decision to keep Juul e-cigarettes ...

Adagene Inc. (ADAG) on Tuesday said that it received directions from the U.S. Food and Drug Administration on further ...

The FDA guidance isn’t expected to require manufacturers to measure how well their devices perform in patients with poor perfusion. All this means that the FDA’s efforts could lead to devices ...