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Legal & Regulatory Issues

Medical device companies have received more scrutiny from federal regulators under President Barack Obama's administration than over the past seven years, according to a new study from Emergo Group, a worldwide medical device regulatory compliance firm.

During the recent oral argument before the United States Supreme Court in the so-called "pay-for-delay" case before it, Justice Antonin Scalia suggested that the Hatch-Waxman Act "made a mistake," and he questioned whether the Court should "overturn understood antitrust" laws…

At the Becker's Hospital Review Annual Meeting in Chicago on May 11, Scott Becker, JD, CPA, partner with McGuireWoods in Chicago and publisher of Becker's Hospital Review, discussed the key legal and risk areas facing hospitals. Meggan Michelle Bushee, JD,…

Based on a recent inspection, the FDA is warning providers and hospital supply managers that drugs produced and distributed by The Compounding Shop in St. Petersburg, Fla., may not be sterile, according to the American Society of Anesthesiologists.

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On the tails of a CMS report released Wednesday showing wide variances in price rates among hospitals, HHS announced it has made more grant money available to support states' rate reviews for health insurance and healthcare pricing.

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