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The upper echelons of the US Food and Drug Administration (FDA) received unwanted attention last week. Daniel Schultz, head of the FDA's medical device division, resigned after allegations from employees that products were approved despite the concerns of agency scientists.
And it emerged that California-based Amphastar Pharmaceuticals had in April asked the FDA that Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, be removed from judging drug approvals of a generic blood-thinner because of her interactions with a competing firm, Momenta Pharmaceuticals, based in Cambridge, Massachusetts. Woodcock asked Momenta's co-founder, Ram Sasisekharan, to lead an FDA task force investigating tainted Chinese-made heparin last year, and she and Momenta scientists then co-authored medical journal articles on the topic. The FDA is looking into the complaints.
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