Tag Archives: REMS

Missed Opportunities in Rare Disease

By Ben Comer | Published: July 20, 2012
At CBI’s 7th Annual Rare Disease and Orphan Drug Leadership Congress, speakers and attendees identified areas where pharma can improve the way it approaches rare disease and treatment.
Posted in Corporate Responsibility, Events, Market Access, Regulatory, leadership, patient compliance, patient education | Also tagged , , , | Leave a comment

Avandia, Pharma, and the New FDA

By Walter Armstrong | Published: October 6, 2010
The Harvard prof who wrote the book on FDA (literally) deconstructs the decision on Avandia—and its future implications. GlaxoSmithKline’s diabetes drug Avandia became mired in such controversy regarding its safety in recent years that it was dubbed “another Vioxx”—exactly what the pharmaceutical industry had vowed never to produce. Two weeks ago, FDA’s decided to restrict access [...]
Posted in FDA, Regulatory, Safety | Also tagged , , , , | 2 Comments