After a two-year stint running the Food and Drug Administration, Scott Gottlieb has joined the board of directors at Pfizer, giving the world’s largest drug maker crucial insights into the inner workings of the Trump administration as it attempts to contain national angst over the rising cost of medicines

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It’s launching their physicians into uncharted territory. Corner-store cannabidiol “scares the bejesus” out of Dr. Jacqueline French. French, a neurologist, tries to steer her patients away from sprinting to the neighborhood bodega to buy versions of the hemp derivative that’s better known as CBD

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Backers of Maryland’s stem cell ecosystem hope a federal judge’s ruling last week in a Florida case that the Food and Drug Administration can regulate stem cell treatments is the first step toward protecting their legitimacy. With comments from our Debra Mathews

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The agency said two patients received donated stool that had not been screened for drug-resistant germs, leading it to halt clinical trials until researchers prove proper testing procedures are in place

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Hiding in Plain Sight

June 5, 2019

Peter Lurie writes, “The FDA’s approach to disclosing new drug applications is a disservice to public health”

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By voice vote, the full Appropriations Committee of the U.S. House of Representatives today restored language to a 2020 spending bill that bars the FDA from considering requests to approve any clinical trial “in which a human embryo is intentionally created or modified to include a heritable genetic modification.”

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In a decision expected to send a chill through the booming stem cell industry, a federal judge ruled in favor of the Food and Drug Administration on Monday in a lawsuit against a Florida-based stem cell company whose treatments have blinded at least four patients

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Congress wants a single ALS patient to get a therapy never tested in humans. A family in Iowa believes the Food and Drug Administration will decide whether their only surviving daughter lives or dies, and they’ve been on a monthslong crusade to break through its bureaucracy. And they’re succeeding

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