Tag Archives: Margaret Hamburg

Will Congress Provide Sequester "Flexibility" for User Fees?

Just about every federal program and affected interest group is pressing for relief from the 8% across-the-board cuts in funding imposed by the budget sequestration mandate. Recent fast action on Capitol Hill to curb personnel furloughs of air traffic controllers by the Federal Aviation Administration, though, has spurred lobbying for similar treatment across many fronts.
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Ethics in Drug Innovation: The First Hurdle is Trust

By Ansis Helmanis Ethics is a matter of trust, which in the regulatory space requires transparency and openness among all stakeholders, including patients and industry.  This was the consensus of FDA Commissioner Margaret Hamburg and European Medicines Agency (EMA) Executive Director Guido Rasi, both of whom shared the podium with Nobel Laureate Professor Elie Wiesel […]
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Drug Shortages Still in Focus

By Patricia Van Arnum. Drug shortages, particularly those for sterile injectable drugs, took center stage last year. In response, industry and the federal government, including FDA, took steps to address the problem. Progress has been made, and Congress is further evaluating if additional steps need to be taken.
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Hamburg Delivers DIA Keynote

FDA Commissioner Margaret Hamburg delivered this year’s keynote speech in front of a packed room of pharma and bioscience personnel at the 46th annual meeting of the Drug Information Association, which opened Monday morning. Hamburg started her speech by explaining how her earliest goal as FDA chief was to build the field of regulatory science—an […]
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New FDA Campaign Targets Detailing, Trade Shows

In addition to sending out more warning letters and stepping up enforcement activity, the Food and Drug Administration wants health professionals to do more to police drug marketing and advertising. The agency’s “Bad Ad” program urges doctors and other health professionals to report any false or misleading ads or inappropriate marketing pitches. Depending on one’s […]
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