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Health Care Partner Quoted in Bloomberg BNA on FDA’s Clinical Trial Regulations

Practices: Health Care

Health care partner Mark Barnes (Boston) is quoted in a March 15 article in Bloomberg BNA’s Medical Research Law & Policy Report on the U.S. Food and Drug Administration (FDA) plan to harmonize its regulations with the Common Rule revisions on clinical trial human subject protection and the impact of President Trump’s executive order to reduce red tape.

While the Trump administration executive order says that for every new regulation issued by an executive department or agency, at least two existing regulations must be identified for elimination, Mr. Barnes indicates that he expects exceptions to be made, noting that “with a revised FDA rule, there will be a relaxation of various individual rules, and so regulatory burden will be reduced overall.”

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