Regulatory

Oct 24, 2016
FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.
Oct 07, 2016
Despite notable deficiencies in the frameworks for assessing the value of prescription drugs, these initiatives are expected to have a major impact on drug utilization and reimbursement.
Sep 28, 2016
ISPOR's Value Assessment Stakeholder Conference showed its Special Task Force still reaching for clarification around the subject, writes Ansis Helmanis.
Sep 28, 2016
The EpiPen eruption plus the emergence of more cutting-edge therapies with drug and biotech components has put combination products under the spotlight. Jill Wechsler reports.
Sep 26, 2016
PDUFA VI to enhance FDA staffing, revise fees and expand evidence for drug development.
Sep 22, 2016
The UK is moving closer to aligning its two approaches to regulating drug pricing — the voluntary PPRS and statutory price cuts — but the headaches are likely to continue, writes Leela Barham.
Sep 19, 2016
The campaign to achieve greater transparency in clinical research activity regulated or funded by the federal government, including the results of those studies, is moving forward after months of debate.
Sep 18, 2016
Concerns have emerged that continued growth in biosimilars could be limited by mounting pressure to push down on prescription drug outlays. Jill Wechsler reports.
Aug 30, 2016
The outrage over Mylan’s price hikes for its EpiPen auto-injector illustrates the many factors that keep drug pricing immune from normal economic pressures, writes Jill Wechsler.
Aug 30, 2016
$7.5 billion in pharma “transfers of value” made in 2015 has caught the attention of the DoJ and federal/state prosecutors investigating fraud. Jill Weschler reports.
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