Author Archives: Jill Wechsler

FDA, Sponsors Seek Study Endpoints Earlier in Development

As payers demand more evidence documenting medical product value, biopharma companies are responding by moving sooner to decide key clinical outcomes to measure. While clinical trials still have to document product safety, efficacy and quality, sponsors also look to demonstrate suitability for formulary placement and reimbursement. Food and Drug Administration officials support these strategies to […]
Posted in FDA, Marketing, R&D, Regulatory, Strategy | Tagged , , , , | 1 Comment

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, […]
Posted in FDA, Gene therapy, Legal, Market Access, R&D, Regulatory, Technology | 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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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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Obama Budget Takes Slap at Pharma

Despite a slight boost in funding for the Food and Drug Administration and stronger tax incentives for investment in R&D, significant changes in Medicare drug reimbursement and coverage policies have biopharmaceutical companies up in arms.
Posted in Biotech, IP, Legal, R&D, Regulatory | Tagged , , , | Leave a comment
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