An FDA/Institute of Medicine workshop on characterizing and communicating the uncertainty inherent in risk/benefit decisions touched on an important topic for every sponsor. But two “case studies” included points a very particular interest to Biogen Idec, and to sponsors in the COPD class.
Uncertainty is fact of life for regulators. FDA officials make drug approval decisions based on inherently incomplete data. Even the largest clinical study can’t answer every question about how a medicine will perform in the real world—and, indeed, the larger the trial the more new questions are likely to arise if you dig deeply into the data.
As Center for Drug Evaluation & Research Director Janet Woodcock put it in her opening remarks to a Feb. 12...
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
