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Focus on Regulation

Tag Archives: health care economic information

21st Century Cures Offers More Latitude to Promote Health Care Economic Information, but Ambiguities Would Remain

Last Wednesday, the U.S. House of Representatives passed the 21st Century Cures Act , the culmination of an extensive, multi-year effort by the House Energy and Commerce Committee to develop this sweeping legislation. The 21st Century Cures Act now faces a vote in the Senate, likely within days.  The White House has already expressed support for

Let’s Get Real: Meredith Manning Urges FDA to Allow Greater Communication of Real World Data Within Its Current Regulatory Framework

On October 26, 2016, Hogan Lovells partner Meredith Manning submitted a comment to the U.S. Food and Drug Administration (FDA) urging the agency to allow the use of observational data in manufacturers’ advertising and promotion of drugs and medical devices. The FDA is holding a public meeting  on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared

FDA Official Offers Interpretation of FDAMA 114 Standard for Health Care Economic Information (HCEI)

Dr. Robert Temple, CDER’s Deputy Director of Clinical Science, recently presented slides at a meeting of the National Pharmaceutical Council on potential uses for comparative effectiveness research.  Significantly, his speech included an interpretation of section 114 of the Food and Drug Administration Modernization Act of 1997 (“FDAMA 114”) applying to HCEI.   We believe that Dr. Temple’s