Category Archives: Regulatory

Breakthrough Therapy Program Exceeds FDA’s Expectations

The two-year-old initiative to accelerate the development and approval of highly effective drugs and biologics has enabled a number of important new medicines to reach patients sooner,  according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). Twelve breakthrough drugs have been approved over the past two years, for several critical […]
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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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