Category Archives: Regulatory

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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Will the Supreme Court Spur OTC Contraceptive Development?

One piece of fall-out from the recent Hobby Lobby decision by the U.S. Supreme Court is to generate talk of Republicans backing development of a nonprescription contraceptive pill. Conservative commentators supported this strategy as a way for Republicans to deflect Democratic charges of a GOP “war on women” and access to safe and effective birth […]
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FDA’s Patient Outreach: Finding Ties that Bind

Is the FDA doing enough to incorporate the patient perspective in the drug review process? This was the key question considered at a panel of regulatory experts held at last month’s annual BIO International Convention in San Diego. The consensus: while FDA deserves high marks for effort, both in reconciling the diversity of patient organization […]
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