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Pivotal Clinical Investigations for Medical Devices

Design Considerations for Pivotal Clinical Investigations for Medical Devices – Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff This document is intended to provide guidance to those involved...

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University of Queensland investigates fresh claims of research misconduct by former academics

http://www.abc.net.au/news/2013-11-07/uq-investigates-fresh-claims-of-research-misconduct/5077276 “One of Australia’s leading universities is investigating new concerns of possible academic misconduct by two former academics. The University of Queensland’s Dr Caroline Barwood and Professor Bruce Murdoch published a peer-reviewed paper in...

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Nature – ‘national interest’ requirement on US science agency

Key members of the US House of Representatives are calling for the National Science Foundation (NSF) to justify every grant it awards as being in the “national interest”. The proposal, which is included in...

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AAAS — GRANT ACT introduced

GRANT Act Marked Up in House Committee. Last week the House Oversight and Government Reform Committee approved the Grant Reform and New Transparency (GRANT) Act (HR 3316), which seeks to enhance transparency in the federal...

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AAAS CONGRESSIONAL NEWS

Senate Patent Litigation Bill. On October 30, Senator Orrin Hatch (R-UT) — former chairman of the Senate Judiciary Committee — introduced the Patent Litigation Integrity Act (S. 1612 (PDF)) to reduce the number of predatory litigation cases. The...

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Judges have free hand on courtroom cameras, court says

http://valawyersweekly.com/2013/10/31/judges-have-free-hand-on-courtroom-cameras-court-says/ “A Virginia statute gives trial judges “great discretion” in deciding whether or not to allow cameras in their courtrooms, the Supreme Court of Virginia ruled Thursday. Upholding the ruling by Charlottesville Circuit Judge...

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Preparing for Responsible Sharing of Clinical Trial Data

NEJM Michelle M. Mello, J.D., Ph.D., Jeffrey K. Francer, J.D., M.P.P., Marc Wilenzick, J.D., Patricia Teden, M.B.A., Barbara E. Bierer, M.D., and Mark Barnes, J.D., LL.M. N Engl J Med 2013; 369:1651-1658October 24, 2013DOI:...

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The Randomized Registry Trial — The Next Disruptive Technology in Clinical Research?

Michael S. Lauer, M.D., and Ralph B. D’Agostino, Sr., Ph.D. N Engl J Med 2013; 369:1579-1581October 24, 2013DOI: 10.1056/NEJMp1310102 The registry-based randomized trial may make less expensive, more efficient clinical studies possible. But before...

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Access to Patient-Level Trial Data — A Boon to Drug Developers

Hans-Georg Eichler, M.D., Frank Pétavy, M.Sc., Francesco Pignatti, M.D., and Guido Rasi, M.D. N Engl J Med 2013; 369:1577-1579October 24, 2013DOI: 10.1056/NEJMp1310771 The provision of access to clinical trial results that include patient-level data...

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Virginia Lawyers Weekly Marriage with Late License is Void

In 2002, a couple in Northern Virginia were married, or at least they thought they were married. In 2011, the wife filed for divorce and for the next two years, they battled through the...

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