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Maine Adopts Final Clinical Trial Reporting Regulations
November 9, 2009, Covington E-Alert
U.S. FDA's New Game Plan For Digital Health
June 16, 2017, Medtech Insight
Wade Ackerman is quoted in a Medtech Insight article regarding FDA's regulatory strategy in relation to digital health. "While Congress addressed some aspects of FDA's regulation of health software in the 21st Century Cures Act last year, the digital landscape continues to evolve rapidly," Ackerman says. "FDA's intent to outline a new digital health innovation ...
May 19, 2017, Bloomberg Law
Shaoyu "Andrew" Chen is quoted in a Bloomberg Law article regarding the latest series of announcements from China's Food and Drug Administration on accelerating drug and medical device approvals. According to Chen, “The four documents proposed many critical policies that will bring China much closer to Western countries in the regulatory oversight of drugs and ...
November 4, 2016, FDA Week
Michael Labson spoke at the FDLI Annual Advertising Conference and is quoted in an FDA Week article regarding communication between drug makers and payers under a section of the FDA Modernization Act. According to Labson, first amendment jurisprudence may make concerns over FDAMA 114 a non-issue. "If the first amendment idea that you have a constitutional right ...