Category Archives: Regulatory

FDA "Stymies Competition in Drug Industry", Says PCMA

By Randi Hernandez. The Pharmaceutical Care Management Association (PCMA), an organization that represents the nation’s leading pharmacy benefit managers (PBMs), which administer prescription drug plans for over 210 million Americans, released a new white paper investigating FDA’s influence on drug prices and competition in the pharmaceutical marketplace. The PCMA argues that competition within branded drugs […]
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EMA Revises Conflict-of-Interest Policy

The European Medicines Agency (EMA) has published its revised policy on handling declarations of interests for scientific-committee members and experts. The revisions strive for a more balanced approach in restricting the involvement of experts with possible conflicts of interests in the Agency’s work, while maintaining access to expertise.
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CMS Struggles to Fix Sunshine System

The feds have “a long way to go” to get the Open Payments system operating effectively and user friendly, according to officials in charge of the financial disclosure program. “Sunshine” went live September 30, 2014, as scheduled, but incomplete and contradictory data listings made it necessary to withhold nearly one-third of financial transaction reports from […]
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No-One's in Charge of Pharmaceuticals in Europe!

Peter O’Donnell’s recent Applied Clinical Trials blog, ‘Who’s in charge of Medicines in Brussels?‘, has been overtaken by history, with the departure of Guido Rasi from his post of Executive Director of the European Medicines Agency. At a time of flux in the European context for pharmaceuticals, Rasi’s moderate manner and capacity for strategic thinking […]
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Meeting Patient-Centered Expectations in Europe

By Peter O’Donnell, Applied Clinical Trials. The growing insistence on making healthcare more patient-centered — Europe is currently awash with declarations of intent along those lines — is generating a new level of interest in helping patients (or even citizens) to meet the expectations that the new orthodoxy is creating. After all, there is little logic […]
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