Articles

DoD Proposes New Framework for Governmentwide Guidance for Grants and Cooperative Agreements

The Department of Defense has published six notices of proposed rule-making to establish an updated interim implementation of government-wide guidance on administrative requirements, cost principles, and audit requirements for federal awards, in relation to...

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NEJM Article on Expanded Use Issues.

FDA approval of investigational drugs takes time, This can be a problem if alternative treatments for the condition are not available. The FDA therefore developed a system of expanded access to permit patients with...

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OMB Request for Comment on Digital Services Playbook

OMB- Request for Comments on Digital Services Playbook and TechFAR Handbook, 79Fed. Reg. 49542, August 21, 2014.SUMMARY:  OSTP and OMB’s Offices of Federal Procurement Policy (OFPP) andE-Government & Information Technology (E-Gov) are seeking public comment...

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Graduate Medical Education Policies Reviewed

The National Academy of Sciences released a report reviewing the current Graduate Medical Education policies and funding within the United States. The report emphasizes the need for continued guaranteed public funding of GME programs...

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HHS amends FAR Supplement

79 Fed. Reg. 49015, August 19, 2014. SUMMARY: The Department of Health and Human Services (HHS) is issuing a final rule to amend its Federal Acquisition Regulation (FAR) Supplement—the HHS Acquisition Regulation (HHSAR)— to add two...

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When Religious Freedom Clashes with Access to Care

The New England Journal of Medicine has an in depth discussion of the Supreme Court Decision in Burwell v. Hobby Lobby Stores and Conestoga Wood Specialties Corp. v. Burwell. Visit: http://www.nejm.org/doi/full/10.1056/NEJMp1407965?query=TOC to read how the decision can...

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Is Research Funding Protected by Due Process?

A lawsuit brought by the former director of the Virginia Bioinformatics Institute at Virginia Tech against the university seeks to answer that question among many others. The Roanoke Times has a more detailed discussion: http://www.roanoke.com/news/local/blacksburg/virginia-tech-employment-lawsuit-could-set-constitutional-precedent/article_48c426f6-8cc9-58f5-a0be-62701e2ce213.html

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AIB Settlement Resolves False Claims Act Allegations

AIB was accused of falsely marketing genetic tests as free when in fact they were billed to Medicare. Related allegations were also resolved in the settlement. Read the press release here: http://www.justice.gov/usao/paw/news/2014/2014_july/2014_07_22_01.html

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NEJM Reacts to Supreme Court ACA Ruling

The New England Journal of Medicine recently published a detailed synopsis of the opinions and implications of the recent Supreme Court ruling regarding the religious objections to the Affordable Care Act requirement for contraceptives...

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New FDA Informed Consent Guidance

A new document being distributed for comments from the FDA seeks to provide updated information on the FDA regulations and processes surrounding informed consent for institutional review boards (IRBs), clinical investigators, and study sponsors. The document is...

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