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OpenAI and the FDA Are Holding Talks About Using AI In Drug Evaluation
High-ranking OpenAI employees have met with the FDA multiple times in recent weeks to discuss AI and a project called cderGPT ...
American Hospital Association1d
FDA commissioner talks of shortening drug approval process, benefits of AI
Food and Drug Administration Commissioner Marty Makary, M.D., spoke about the need to shorten the length of the drug approval ...
Rare Disease Industry Awaits FDA Chief’s New Drug Pathway Plan
FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...
JD Supra6d
Conditional Approval Proposals for FDA: Current Context and Potential Ramifications
Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...
BusinessWorld on MSN3d
FDA expects speedier drug permit process
THE new Food and Drug Administration (FDA) application procedures are expected to reduce the drug permit process by as much ...
STAT1dOpinion
How to stop the shift of drug discovery from the U.S. to China
U.S. pharmaceutical companies are increasingly licensing new drugs from China. Former FDA Commissioner Scott Gottlieb ...
STAT9d
U.S. health officials inject new uncertainty into approval process for Covid boosters
Confusion over the FDA delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend, with possible ...
Inquirer Business on MSN2d
FDA promises to cut by half approval time for new products
The country’s regulator on food, drugs and cosmetics is looking to speed up its approval process, targeting to cut by half ...
Fierce Biotech7d
UPDATE: FDA misses PDUFA date for Stealth’s ultra-rare disease candidate, delaying approval decision—again
An approval decision for Stealth BioTherapeutics’ investigational treatment for an ultra-rare genetic disease has been ...
Cytokinetics: Strong Buy As FDA's 3-Month Delay Doesn't Derail Aficamten's Approval Outlook
The FDA extended aficamten's review by three months for REMS safety program finalization, causing Cytokinetics' stock to drop ...