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Martin Makary

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FDA's response letter salvo sheds light on drug refusal process

The FDA's response letter salvo offers an in-depth view into the high-stakes discussions that decide whether a medicine will ever make it to market.
James Waldron , Fraiser Kansteiner Jul 11, 2025 10:15am
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Biotech leaders urge FDA to not restrict abortion pill access

Jul 2, 2025 2:14pm
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FDA's acting CDER head heads for the exit: report

Jun 23, 2025 1:48pm
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FDA debuts priority review voucher with 2-month timeline goal

Jun 17, 2025 11:59am
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At cell and gene roundtable, officials pledge to slash regulations

Jun 5, 2025 2:50pm
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FDA launces generative AI tool Elsa a month ahead of schedule

Jun 3, 2025 10:40am

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