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CMS addresses reporting rules for CME events

USA - November 6 2014 In July 2014, the Centers for Medicare and Medicaid Services (CMS) published proposed amendments to its rules implementing the Sunshine Act. Among...

Christine N. Bradshaw, Ingrid A. Pelzer.

FDA issues draft guidance to help companies distinguish between a voluntary medical device recall and a product enhancement

USA - May 23 2013 On February 22, 2013, the Food and Drug Administration (FDA) issued a draft guidance entitled "Distinguishing Medical Device Recalls from Product...

Stephen C. Matthews.

Second Circuit: truthful off-label promotion of prescription drugs is protected by the First Amendment

USA - December 5 2012 On December 3, 2012, the United States Court of Appeals for the Second Circuit ruled that a pharmaceutical sales representative could not be convicted for truthful off-label promotional statements made to physicians about a drug that had been approved by the FDA for other uses....