Archive for July, 2014

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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New England Journal of Medicine Reacts to CMS Data Release

The New England Journal of Medicine has two perspective pieces on the recent public data release by the Centers for Medicare and Medicaid Services (CMS). The first provides the reasoning and context from the perspective...

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FDA Releases Guidance on GUDID

The FDA has just released the finalized version of it’s “Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff.” The document outlines the process of submitting data to...

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