Category Archives: FDA

Drug-Diagnostic Development Stymied by Payer Concerns

The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy and clinical utility of companion diagnostic tests. Even for the handful of drugs approved by the Food and Drug Administration with labeling that links prescribing to specific biomarker measures, health plan operators, […]
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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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FDA Details National Vaccine Plan

Dr. Karen Midthun, director of FDA’s Center for Biologics Evaluation and Research, outlined the importance of the Department of Health and Human Services (HHS) National Vaccine Plan, in a FDA blog on March 11, 2014. Midthun points out how crucial vaccines are in protecting public health and discusses FDA’s role in ensuring a stable supply […]
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Obama Administration Halts Attack on Medicare Drug Plans

In an abrupt about-face, the Obama administration halted its ill-timed effort to launch an overhaul of the Medicare Part D program and announced it would not pursue changes in some key rules as proposed earlier this year. CMS had issued a proposed rule January 10 to drop “protected” class status for antidepressants and immunosuppressants in […]
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Track-and-Trace Not Enough to Halt Drug Counterfeiters

Despite recent legislation to establish a more secure pharmaceutical supply chain to deliver high quality, approved medicines to American patients, efforts to block the import of substandard, fraudulent, and counterfeit drugs remains an uphill fight. Criminals are expanding from “lifestyle” drugs to widely used anti-cholesterol and cancer medicines, attracted by huge profits and low risks […]
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