Category Archives: Regulatory

Experts Tell Congress How to Streamline Clinical Trials

Key to accelerating the discovery and development of new medical therapies is to improve the clinical research process, according to leaders of biopharmaceutical research community. As part of its 21st Century Cures Initiative, the House Energy & Commerce Committee called on representatives of industry and academia to present strategies for reducing regulatory oversight, speeding up […]
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EMA Delays Adoption of Policy on Publishing Trial Data

The European Medicines Agency (EMA) has postponed formal adoption of the policy on publication of clinical trial data. An EMA press statement said that “[f]urther clarifications on wording and practical arrangements will be discussed by Board members”, whose additional contributions will now be considered with a view to reaching final agreement at the Management Board meeting on 2 October. […]
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European Pharma Policy Reaches "New Level of Timidity"

By Peter O’ Donnell, Applied Clinical Trials. The European Union has managed to snatch defeat from the jaws of opportunity once more! A long-heralded document portentously entitled “Pharmaceutical industry: a strategic sector for the European economy,” and supposedly initiating a new start in long-term thinking about boosting the drug industry, squeezes the thinnest and weakest […]
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Open Payments: A New Dawn for Transparency

The Physicians Payment Sunshine Act, more formally referred to as Open Payments, has been in place for almost 18 months. It is only in the next few months, however, that the implications of the law and its contentious requirements will start to be fully realised. Michael Christel reports.
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Value-Based Assessment in the UK: The Industry View

By Leela Barham. In the UK, Value-Based Pricing (VBP) has morphed into Value-Based Assessment (VBA), with the National Institute for Health and Care Excellence (NICE) tasked with taking the loose policy concepts (established as far back as 2010) and actually implementing them. Earlier this year, NICE set out its approach, which boiled down to taking a […]
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