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 SightJune 5, 2019 |
Peter Lurie writes, “The FDA’s approach to disclosing new drug applications is a disservice to public health”
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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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When ‘Right to Try’ Isn’t EnoughMay 31, 2019 |
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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Cancer drugs that speed onto the market based on encouraging preliminary studies often don’t show clear benefits when more careful follow-up trials are done, according to research published Tuesday
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It barred the FDA from considering any clinical trial application “in which a human embryo is intentionally created or modified to include a heritable genetic modification.” Although a different “rider” bars the NIH from funding human germline editing—or the genetic modification of sperm, eggs, or embryos
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The military is constantly using technology to build better ships, warplanes, guns and armor. Shouldn’t it also use drugs to build better soldiers?
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