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FDA issues Revised Draft Guidance on disclosures of risk information in consumer-friendly print advertisements and promotional labeling

USA - March 19 2015 The U.S. Food and Drug Administration (FDA) recently released its Revised Draft Guidance entitled “Brief Summary and Adequate Directions for Use:…

CMS finalizes proposal to remove continuing medical education exclusion from Sunshine Act regulations

USA - November 12 2014 On October 31, 2014, the Centers for Medicare & Medicaid Services (CMS) issued its final Medicare physician fee schedule rule for CY 2015 (the Final…

Jason B. Caron, Jiayan Chen, Jennifer S. Geetter, Joan Polacheck

CMS proposes removing CME exclusion from Sunshine Act regulations, citing redundancy with indirect payment exclusion

USA - August 7 2014 In the July 3, 2014, issue of the FederalRegister, The Centers for Medicare & Medicaid Services (CMS) published the proposed calendar year 2015…

Jiayan Chen, Jennifer S. Geetter, Joan Polacheck

Identifying and mitigating liabilities in medical device M&A

USA - May 29 2014 Medical device mergers and acquisition (M&A) transactions are accelerating as greater regulatory clarity develops and review times shorten in the U.S…

Kristian A. Werling, Jake Townsend

FDA updates guidance addressing distribution of scientific and medical publications on unapproved new uses

USA - March 10 2014 On February 28, 2014, the U.S. Food and Drug Administration (FDA) released a draft guidance entitled "Distributing Scientific and Medical…

Michael W. Ryan