Archive for January, 2014

Federal investigation apparently finds ‘reckless’ falsehoods in NCSU research

http://www.newsobserver.com/2014/01/29/3575043/federal-investigation-apparently.html#storylink=cpy BY JOSEPH NEFF jneff@newsobserver.comJanuary 29, 2014 A federal investigation into research misconduct at N.C. State has apparently found that two chemistry professors and a graduate student falsified research in a groundbreaking 2004 paper...

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SBA Amends Small Business Innovation Research (SBIR) And Small Business Technology Transfer (STTR) Program Policy Directives

http://content.govdelivery.com/accounts/USSBA/bulletins/a1c2bc   WASHINGTON – The U.S. Small Business Administration (SBA) has amended its Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directives in response to public comments and input...

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New IRS Rules Help Small Nonprofits To Reinstate A Revoked Tax-Exempt Status

New streamlined procedures for reinstating the tax-exempt status of organizations that have had their tax-exempt status automatically revoked for failure to file required Annual Returns or notices for three consecutive years. rp-14-11 reinstatment of tax exempt...

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European Union Negotiations Reach Agreement On New Clinical Trials Regulation

Article by Mark Barnes, Eve M. Brunts and Albert F. Cacozza, Jr. Ropes & Gray LLP “The European Union (“EU”) has cleared the way for adoption of a new clinical trials regulation within the EU. On December 20,...

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NEJM Fully Transparent Medical Records

Forty years ago, Shenkin and Warner argued that giving patients their medical records “would lead to more appropriate utilization of physicians and a greater ability of patients to participate in their own care.”1 At that...

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Preliminary Cybersecurity Framework for improving critical infrastructure cybersecurity

Executive Order “Improving Critical Infrastructure Cybersecurity” directed NIST to work with stakeholders to develop a voluntary framework for reducing cyber risks to critical infrastructure. Preliminary Cybersecurity Framework On October 29, 2013, NIST announced a...

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CMS Issues New Guidance on 2-Midnight Rule

AAMC Washington Highlights  CMS Issues New Guidance on 2-Midnight Rule November 8, 2013—The Centers for Medicare and Medicaid Services (CMS) Nov. 1 issued three new documents about the “2-Midnight Rule.” The new documents include additional guidance, ...

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Good article on patenting post Mayo

The future of prenatal molecular diagnostics: impact of the changing patent landscape Tara L Rachinsky Pharmaceutical Patent Analyst January 2014, Vol. 3, No. 1, Pages 1-3 , DOI 10.4155/ppa.13.76 (doi:10.4155/ppa.13.76) http://www.future-science.com/doi/full/10.4155/ppa.13.76

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THE OFFICE FOR CIVIL RIGHTS DID NOT MEET ALL FEDERAL REQUIREMENTS IN ITS OVERSIGHT AND ENFORCEMENT OF THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT SECURITY RULE

OCR did not meet Federal requirements critical to the oversight and enforcement of the Security Rule: Although OCR made available to covered entities guidance that promoted compliance with the Security Rule, it had not...

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Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics

This draft guidance is intended to describe FDA’s current thinking about how manufacturers, packers,  and distributors (firms), that may either be the applicant or acting on behalf of the applicant, of prescription human and...

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