In an article that reads like informal guidance, U.S. FDA Commissioner Marty Makary and CBER Director Vinay Prasad discussed the criteria for using the agency’s novel plausible mechanism pathway for personalized treatments when a randomized trial isn’t feasible, as well as future uses of the approval path that could expand beyond gene and cell therapies to other biologics and even small molecules.
A team of five members of the U.S. FDA staff published a review of the use of AI in health care and concluded that while hallucinations in AI systems can be minimized, the trade-off is that efforts to minimize hallucinations tend to diminish the AI’s performance.
In reaching within to name 26-year FDA veteran Richard Pazdur as the next CDER director, FDA Commissioner Marty Makary likely chose the best possible person to helm the drug evaluation center at a time marked by uncertainty, morale issues and upheaval, according to several agency watchers.
The U.S. House is expected to vote late Nov. 12 on an amended continuing resolution (CR) to end the historic 43-day partial government shutdown. Already passed by the Senate, the CR would fully reopen the government and fund it through Jan. 30. President Donald Trump has said he will sign the CR, which ensures federal employees furloughed during the shutdown will receive back pay and will not be terminated.
Recent progress in redressing the historical underfunding and neglect of women’s health could be undermined by the backlash against diversity, equity and inclusion (DEI) initiatives, according to executives participating in the FT Global Pharma and Biotech Summit 2025 in London Nov. 11-12.
Australia’s Therapeutic Goods Administration has made a few adjustments to its advertising guidelines for social media promotions, including the requirement that the manufacturer is responsible for anything posted by influencers who are acting on behalf of the manufacturer.
Magstim Co. Ltd. reported that the U.S. FDA cleared its Magstim Rapid magnetic stimulation system for the treatment of chronic pain. The clearance provides a clinically validated therapy that directly targets neural pathways involved in pain processing to deliver a non-invasive, drug-free treatment for chronic pain.
One of the problems of doing business in the EU is that each member nation has its own more or less unique requirements for clinical trial registration, but the Medical Device Coordination Group may have a solution in the form of a pilot program for harmonized clinical trial registration.
Evotec SE has received a $5 million milestone payment from Bristol Myers Squibb Co. (BMS), following the acceptance of an IND application by the FDA in the companies’ strategic protein degradation partnership.
A four-way interagency initiative in South Korea, started in 2020, is working to bolster funding for the local medical device industry and grow homegrown devices for the global market.
RSS
