Tag Archives: REMS

Better Safe than Sorry: Assessing Suicide Risk in Clinical Trials

With the FDA striving to avoid post-market reactions to drugs with worrisome side-effect profiles, preventive measures that screen for obvious risks such as suicidal behavior and abuse potential are making their way into the lexicon of regulators and drug developers alike, in tandem with its mandate that stresses safety first and efficacy a close second. […]
Posted in compliance, FDA, R&D, Regulatory, Safety, Strategy | Also tagged , , , , , , , , | 2 Comments

Missed Opportunities in Rare Disease

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, leadership, Market Access, patient compliance, patient education, Regulatory | Also tagged , , , | Leave a comment

Avandia, Pharma, and the New FDA

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 […]
Posted in FDA, Regulatory, Safety | Also tagged , , , , | 2 Comments
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