Supposedly, the AI tool will speed up the FDA's drug review process by reducing the time its scientists have to spend doing ...

After a 20% cut to the FDA’s workforce, biotechs and pharmas are bracing for delays. But the impacts won’t be consistent.

FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...

Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified ...

The US Food and Drug Administration (FDA ... The AI tools will be deployed immediately and will expedite the review process by enabling FDA scientists and subject-matter experts to spend less time on ...

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

"C-Path was built on the vision that no single entity can solve the challenges of the drug development process alone," said ... its early days supporting the FDA's Critical Path Initiative ...

Food and Drug Administration Commissioner Marty Makary, M.D., spoke about the need to shorten the length of the drug approval ...

The FDA is looking into how AI could help with final drug approvals and improve internal tasks like checking whether an ...

The meetings appear to be part of a broader effort at the FDA to use this technology to speed up the drug approval process. “Why does it take over 10 years for a new drug to come to market?” ...

Today, we talk about the FDA’s new artificial intelligence ... Speaking of AI, Insitro, the AI drug development company launched by Stanford’s Daphne Koller, has cut 22% of its workforce ...