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  • Feature ArticlesFeature Articles

    Sunshine Act Reporting: Research Payments and Requests for Delayed Publication

    On 8 February 2013, the US Centers for Medicare and Medicaid Services (CMS) issued its final rule on the reporting requirements for certain payments and other transfers of value under the Patient Protection and Affordable Care Act ( PPACA ), commonly referred to as the Physician Payment Sunshine Act ( Sunshine Act ). 1 The types of payments, identifying information and classifications for such payments and transfers are outlined in the final rule and require manufac...
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    Orange Book Listings Lesson: An overly broad use code may lead to legal challenges

    The US court system has been busy recently with issues affecting the pharmaceutical industry, including a number of cases involving the Hatch-Waxman Act. On 17 April 2012, the Supreme Court issued a unanimous decision in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S marking the first Abbreviated New Drug Application (ANDA) case decided by the high court since the passage of the act in 1984. The Supreme Court has a long history of overturning Federal C...