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 ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.

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

JUUL GETS ITS CROWN — The FDA authorized Juul’s applications on Thursday to sell e-cigarettes in the U.S., determining ...

Additionally, FDA has scheduled a public webinar on the draft guidance on February 18, 2025. 1 FDA, Draft Guidance for Industry & FDA Staff, Artificial Intelligence-Enabled Device Software ...

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

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 ...

The Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued on May 2 may give DCTs the shot-in-the-arm they need for broader adoption – not because of the ...

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 ...

The agency's draft guidance is the first update since 2018 for products aimed at the earliest stages of the disease, which the FDA defines as stages 1, 2, and 3. Such guidance — when it is made ...