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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.

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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.

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New draft guidance from the FDA says single-target antibodies will no longer need six-month toxicity testing in animals like macaques.

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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.

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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.

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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.

FDA could hike user fees for ex-US drug programmes

Tracy Beth Hoeg will be fifth CDER head this year

FDA takes steps to limit non-human primate testing

Pazdur to leave FDA, shortly after taking CDER job

FDA doubles down on its push into AI

Is FDA about to restrict vaccination even further?

NHS staff 'feel unprepared for digital transformation'

How to meet your physicians where they are online

FDA

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