Tag Archives: Regulatory

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 […]
Posted in Europe, Global, Guest Blog, Op-Ed, R&D, Regulatory, Safety | Also tagged , , , , | Leave a comment

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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NICE's Tarceva Decision "Perverse", Says Roche

The UK National Institute for Health and Care Excellence’s (NICE) decision that relapsed non-small cell lung cancer patients should no longer have access to Roche’s cancer pill Tarceva (erlotinib) is a setback for lung cancer care in England and Wales, where “over 1,000 patients a year will be left without an active treatment option after […]
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