The Next Web1d
Will AI revolutionise drug development? Researchers say it depends on how it’s used
A high drug failure rate is more than just a pattern recognition problem. Here's how we can address some of the root causes.
BioSpace3d
What Trump’s Second Term Could Mean for PDUFA’s Future
Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...
JD Supra7d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
pharmaphorum5d
FDA issues first guidance on AI in medicine development
According to the US regulator, the use of AI in drug development and ... engage with it early on in the development process to get feedback on credibility. The FDA action follows the finalisation ...
JD Supra22d
FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know
The Food and Drug Administration (FDA) has recently released two draft ... its architecture and development process, describing in detail datasets and subsets used in training and tuning including ...
Charlotte’s Web Founder Aims For FDA Approval Of Autism Spectrum Disorder Drug
Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a ...
FiercePharma2d
Pfizer's Braftovi combo on track for full approval in win for FDA's Project FrontRunner
Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in ...
Auron Therapeutics Announces FDA Clearance to Initiate Clinical Development of AUTX-703 and Completion of Series B Financing
Preparing to Initiate Clinical Development in Patients with Hematologic Malignancies in the First Quarter of 2025Series B Financing Funds ...
The FDA pulls key DEI initiative for cancer studies from its website
A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...