Tag Archives: Regulatory

Medicare Data Raises Questions About Drug Costs

The recently released Medicare data on payments to individual doctors doesn’t provide specifics on prescription drug outlays, but opens the door to scrutiny of Medicare reimbursement for medicines delivered in physician offices, writes Jill Wechsler. The Centers for Medicare and Medicaid Services (CMS) has released data on payments to some 880,000 healthcare providers who collectively […]
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Adaptive Licensing: The Start of a Slow Revolution in Europe

By Peter O’ Donnell. So at last it’s happened. Adaptive licensing has leapt from the pages of learned journals into the real world of European regulation. Is this the beginning of the end of binary decision-making on the merits of a new medicine? Has a half-century of the “yes/no” authorization process peaked, to be replaced […]
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Social Media Raise Concerns for Marketers, Trial Sponsors

While biopharmaceutical companies are using websites and third-party postings to provide information on medical products — despite a host of regulatory issues — social media use is in its infancy related to the design and conduct of clinical trials. A recent report from the Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) finds that […]
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"Close Call" for American Rx Marketers on Medicare Part D

As the U.S. heads towards a public market place in which Medicare, Medicaid, CHIPs, VA, and now Obamacare will shortly comprise almost 70% of the American healthcare market, American Rx marketers recently endured a “close call” with the U.S. Department of Health and Human Services over the arbitrary deletion of dozens of key drugs from […]
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Risk-Based Monitoring: From the Road Less Traveled to Productivity Superhighway

Risk-Based Monitoring:  From the Road Less Traveled to Productivity Superhighway By:  Mukhtar Ahmed, global vice president, life sciences strategy, Oracle Health Sciences The latest news on the growing cost of conducting clinical trials is becoming a major concern for company sponsors and trial co-operative groups.  Clinical trials cost 60% more today than they did just […]
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