FDA

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The FDA could make it harder for developers of CAR-T therapies to bring them to market by requiring full randomised controlled trials.

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The FDA is rolling out a pilot programme that could make it easier to bring digital health technologies for chronic diseases to market more quickly.

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FDA mulls reduced fees for programmes with US-based phase 1 trials, and higher fees for those tested overseas, to incentivise US R&D.

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Tracy Beth Høeg, who has very little regulatory experience, is making the switch from CBER to replace FDA veteran Richard Pazdur.

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New draft guidance from the FDA says single-target antibodies will no longer need six-month toxicity testing in animals like macaques.

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Long-serving FDA figure Richard Pazdur has filed papers to retire, shortly after being appointed to lead CDER, according to reports.