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

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.

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

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

Savara faces an FDA setback for Molbreevi, its aPAP treatment. Learn how the company plans to recover and file a new BLA by ...

An estimated 53 drugs would not enter the market in the next 30 years if the NIH is hit with a permanent 10% budget cut and the FDA experiences a nine-month drug review delay due to staffing cuts, the ...

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 ...

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 ...