News

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 ...
FDA, OpenAI discussing use of AI for drug evaluation
The FDA is looking into how AI could help with final drug approvals and improve internal tasks like checking whether an ...
American Hospital Association4d
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 ...
Trump signs executive order to encourage US drug manufacturing
U.S. President Donald Trump signed an executive order to speed up the approval of drug manufacturing plants in the United ...
Trump Appointed Martin Makary Targets Faster Drug Approvals With FDA Artificial Intelligence Overhaul
FDA will implement a secure generative AI system across all centers by June 30, aiming to streamline internal reviews and ...
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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 ...
JD Supra9d
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 ...
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 ...
New FDA Leadership Could Raise The Bar For Drug Approvals
A former critic of FDA and Pharma will now oversee the regulation of costly and complicated biologics like vaccines, gene therapies, and blood supply.