Archive for March, 2014

NEJM — New FDA Breakthrough-Drug Category — Implications for Patients

New FDA Breakthrough-Drug Category — Implications for Patients Jonathan J. Darrow, S.J.D., J.D., M.B.A., Jerry Avorn, M.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H. N Engl J Med 2014; 370:1252-1258 March 27, 2014 DOI: 10.1056/NEJMhle1311493 http://www.nejm.org/doi/full/10.1056/NEJMhle1311493?query=TOC...

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openFDA — New opportunity for app developers and others

openFDA is a new initiative in the Food and Drug Administration’s Office of Informatics and Technology Innovation spearheaded by FDA’s Chief Health Informatics Officer. openFDA will offer easy access to FDA public data.  On launch,...

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SCIENCE SHOT Why Is Dark Chocolate Good for You? Ask Your Gut

18 March 2014 3:45 pm Science “Dark chocolate really does a body good, and scientists now have a better idea why. Gut bacteria break down large compounds in its key ingredient, cocoa powder, into...

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NO attorney client privilege for internal investigation by government contractor

United States ex rel. Barko v. Halliburton Co., No. 1:05-CV-1276 A government contractor’s internal investigation reports into alleged misconduct of its employees are not privileged  because the investigations were undertaken to comply with regulatory...

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Humanitarian Device Exemption (HDE): Questions and Answers – Draft Guidance for HDE Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff

DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: March 18, 2014 You should submit comments and suggestions regarding this draft document within 90 days of publication in...

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Sex-Specific Medical Research — Why Women’s Health Can’t Wait

A Report of the Mary Horrigan Connors Center for Women’s Health & Gender Biologyat Brigham and Women’s Hospital ATTACHED BELOW “While this report focuses on women, understanding health differences is valuable to all who...

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Mobile Medical Applications updated FDA page

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery The widespread adoption and use of mobile technologies is opening new and innovative ways to improve health and health care delivery. Mobile applications (apps) can help people manage their own health and wellness,...

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Administrative Procedures for CLIA Categorization – Guidance for Industry and Food and Drug Administration Staff

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070762.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery On February 28, 1992, the Department of Health and Human Services (DHHS) published laboratory standards regulations (57 FR 7002) implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. 263a).  The implementing...

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Good advice

Professor Ralph Nash, one of the most distinguished scholars of government contracting law, provides this list of “Mistakes in Contract Administration.” I didn’t read the contract! I didn’t try to understand the three R’s –...

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Teaching Hospitals and the Physicians Sunshine Act (reporting of payments by drug and device companies to health care providers)

http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Teaching-Hospitals.html Teaching Hospitals Definition For the purposes of Open Payments, “teaching hospitals” are hospitals that received payment for Medicare direct graduate medical education (GME), inpatient prospective payment system (IPPS) indirect medical education (IME), or...

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