News FDA could hike user fees for ex-US drug programmes FDA mulls reduced fees for programmes with US-based phase 1 trials, and higher fees for those tested overseas, to incentivise US R&D.
News Tracy Beth Hoeg will be fifth CDER head this year Tracy Beth Høeg, who has very little regulatory experience, is making the switch from CBER to replace FDA veteran Richard Pazdur.
News FDA takes steps to limit non-human primate testing New draft guidance from the FDA says single-target antibodies will no longer need six-month toxicity testing in animals like macaques.
News Pazdur to leave FDA, shortly after taking CDER job Long-serving FDA figure Richard Pazdur has filed papers to retire, shortly after being appointed to lead CDER, according to reports.
News FDA doubles down on its push into AI The FDA has revealed the latest element in its adoption of AI, an agentic AI platform that agency staffers can use to streamline complex tasks.
News Is FDA about to restrict vaccination even further? Vinay Prasad, head of CBER, is reported to be planning to tighten regulations on vaccines after concluding that COVID-19 shots caused 10 child deaths.
News FDA points to liver injury with Amgen's Tavneos The FDA has raised the pressure on Amgen to withdraw vasculitis drug Tavneos from the market with a report linking serious side effects to the drug.
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