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

Improving how the FDA disseminates already-public information about approved drugs may be unsexy, but it would be a big step ...

But three of those FDA employees told CNN that Elsa just makes up nonexistent studies, something commonly referred to in AI ...

Tidmarsh, an adjunct professor at Stanford’s medical school, brings decades of industry experience to the table. Serving as ...

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...

Michael Lewis on Heather Stone of the Food and Drug Administration. Heather Stone, a science policy analyst for the Food and Drug Administration's Center for Drug Evaluation and Research, at the ...

The FDA has posted a summary of Novo Nordisk (NVO) site inspections made over several dates in March of this year at the company’s Drug Substance Manufacturing Site in Kalundborg Sjalland 4400 ...

U.S. Food and Drug Administration (FDA) has assigned a target action date of June 23, 2025 December 23, 2024 08:00 AM Eastern Standard Time ...

Just as the U.S. market has adapted to the increase in sales of approved GLP-1 drugs, leading to FDA-declared drug shortages and the availability of compounded versions, the litigation landscape ...

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and unnecessary delays in the regulatory process.

The FDA’s proposed amendments to 21 CFR Parts 600, 610 and 680, published in the Federal Register on June 21, 2011, for review and comment, are focused on expanding the scope of the current ...