Category Archives: Regulatory

Randomized Trials Key to Determining Effectiveness of Ebola Therapies and Vaccines

US researchers and regulators continue to support the use of randomized clinical trials to test potential treatments and vaccines to combat the Ebola virus, despite objections that this approach is unethical and unfair to vulnerable populations. Anthony Fauci, director of the National Institute of Allergy & Infectious Diseases (NIAID), articulated the case for “gold-standard” randomized […]
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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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