Mark Barnes

Mark Barnes

Ropes & Gray LLP

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One Step Away: European Parliament Approves New Clinical Trials Regulation

On April 2, 2014, the European Parliament approved the new clinical trials regulation (the “Regulation”) for the European Union (“EU”), with 594 votes in favor, 17 opposed and 13 abstentions. The European Parliament approved...more

4/8/2014 - Clinical Trials EU

European Union Negotiations Reach Agreement on New Clinical Trials Regulation

The European Union (“EU”) has cleared the way for adoption of a new clinical trials regulation within the EU. On December 20, 2013, the Committee of Permanent Representatives of the European Union endorsed proposed revisions...more

1/23/2014 - Clinical Trials Data Protection EU Informed Consent Peer Review

OMB Publishes Final Uniform Guidance on Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards

On December 26, 2013, the Office of Management and Budget (“OMB”) published final guidance in the Federal Register entitled “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards”...more

1/6/2014 - Audits Compliance Fraud and Abuse Grants OMB Waste

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