Category Archives: Regulatory

Meeting Patient-Centered Expectations in Europe

By Peter O’Donnell, Applied Clinical Trials. The growing insistence on making healthcare more patient-centered — Europe is currently awash with declarations of intent along those lines — is generating a new level of interest in helping patients (or even citizens) to meet the expectations that the new orthodoxy is creating. After all, there is little logic […]
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New Republican Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy

The 2014 mid-term elections handed over control of the Senate to Republicans and boosted the GOP majority in the House, a clear blow to Obama administration policies, including the president’s landmark health reform initiative.  Voters were most dismayed about the economy and lack of jobs, but U.S. military snafus overseas and concerns about the Ebola […]
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So Who’s in Charge of Medicines in Brussels?

So now we know who is to do what on health issues in the new European Commission. Or do we? The furor that the new boss of the commission, Jean-Claude Juncker, unleashed with the plans for his new team, weeks before it took office, is still reverberating around Brussels. Peter O’ Donnell reports on the […]
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"Sunshine" Policy Continues To Exempt CME Funding

A federal policy issued late last week appeared to deal a serious blow to continuing medical education (CME) programs supported by biopharma companies. But the specifics published by the Centers for Medicare and Medicaid Services (CMS) Oct. 31, 2014 actually continue to exempt independent CME funding from the Open Payments reporting requirements for transfers of […]
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Legislators Urge Added Incentives for Ebola Drug Development

Leading Senators are proposing legislation to add Ebola to the list of diseases eligible for priority review vouchers from the Food and Drug Administration as an incentive for biopharma companies to invest in treatments for this deadly disease. The priority review voucher (PRV) program for neglected tropical diseases (NTDs) currently applies to 16 deadly conditions […]
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