Transparency

FDA Debuts OpenFDA Database

FDA Debuts OpenFDA Database
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On June 2, 2014, the Office of Informatics and Technology Innovation (OITI) within the Food and Drug Administration (FDA) announced the launch of OpenFDA, a searchable, online public health database containing drug adverse event information compiled between October 2004 and June 2013.  The FDA press release reports that OpenFDA employs a search-based Application Program Interface […]

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The FDA as Researcher: Empirical Research on the Impact of Potential Policy Reforms

The FDA as Researcher: Empirical Research on the Impact of Potential Policy Reforms
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In addition to being one of the primary federal agencies responsible for regulating health-related research, the FDA also sometimes undertakes research in its own right, including studies designed to assess the merits of potential policy reforms.   For example, in recent years, the FDA has conducted studies on subjects such as how consumers use and understand […]

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Potential Effects of Clinical Trial Data Sharing on Biopharmaceutical Innovation

Potential Effects of Clinical Trial Data Sharing on Biopharmaceutical Innovation
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We are very pleased to welcome Dana Darst, a Master of Science in Jurisprudence candidate in Health Law and Intellectual Property Law here at Seton Hall, to the blog today. In recent years, biopharmaceutical research and development organizations have established partnerships with academic institutions and start-up biotechnology companies to drive external innovation, complementary to their own […]

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War on Disclosure: Recent Fronts in Health Care

Filed in Transparency by on June 5, 2012 2 Comments
War on Disclosure: Recent Fronts in Health Care
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Corporations are at war with disclosure in many important fields.  Two notable fronts have recently opened in health care: 1) Fracking processes have become highly controversial because secret chemicals may end up compromising water supplies.  Pennsylvania has now limited doctors’ ability to speak about their concerns: Under a new law, doctors in Pennsylvania can access information about […]

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Physician Payment Sunshine Act Proposed Regulations Out

Filed in Bioethics, Drugs & Devices, Transparency by on January 3, 2012 1 Comment
Physician Payment Sunshine Act Proposed Regulations Out
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CMS has published proposed rules for its implementation of the Physician Payment Sunshine Act (SUNSHINE ACT or Act), which was enacted by Congress as part of the 2010 Patient Protection and Affordable Care Act.  In short, the SUNSHINE ACT requires life science companies to report annually to CMS their conferral of anything of value, whether […]

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