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

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

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

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.

The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.

We need a dedicated framework that clarifies the rules, requirements and incentives for those building personalized ...

The FDA provides guidance regarding the requirements for informed consent set forth in FDA regulations at 21 CFR §§ 50.20 et seq., including a detailed discussion of the eight basic elements ...

Additionally, FDA has scheduled a public webinar on the draft guidance on February 18, 2025. 1 FDA, Draft Guidance for Industry & FDA Staff, Artificial Intelligence-Enabled Device Software ...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

While the FDA guidance is new, research on the benefits of psychedelics is not. Applied Clinical Trials reports that there are currently 163 Phase I, II, or III studies on clinicaltrials.gov ...