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35:09
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U.S. Food and Drug Administration
FDA Direct, Ep. 9 – Faster Reviews, Food Dye Wins and Protecting American DNA
In this episode of FDA Direct, we cover key updates straight from the top – including Commissioner Makary’s presence at the BIO Conference and the FDA’s continued engagement with industry leaders at the CEO Forum in Boston. Plus, we break down the latest announcements on priority review vouchers to the FDA reviewing new clinical trials ...
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4 months ago
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FDA Direct: Catching Up on Agency Reforms
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The Food and Drug Administration recently announced it would begin asking drug companies to remove so-called “black box” warnings for hormones prescribed to treat symptoms of menopause. The FDA says the warning has dissuaded generations of women from taking advantage of the medication that could help them. The move comes months after public health leaders faced criticism for a different decision. Despite years of scientific research, no study has shown that acetaminophen, the main ingredient in
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