BIO Looking For Clinical Trial Reform Priorities
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Trade organization may put its lobbying muscle behind ideas intended to lower trial costs and raise efficiency.
You may also be interested in...
FDA Carrots And Sticks Are Best Way To Get Subgroup Data, Advocates Say
Stakeholders tell FDA it should force sponsors to recruit more diverse populations for its clinical trials by refusing to approve applications with inadequate data or expediting those with the necessary information.
PhRMA’s “I’m In” Campaign Looks To Connect Minorities To Studies
Extension of the Clinical Trial Engagement Network is aimed at increased diversity in clinical trials, which is becoming increasingly important as more drugs are targeted at specific groups.
FDA’s First Breakthrough Designations Continue Vertex Kalydeco’s Regulatory Successes
Label expansion efforts for Vertex’s cystic fibrosis therapy will be claims taken through FDA’s new review pathway; the initial product could reach more patients more quickly and serve as a guide to how the agency will handle drugs earmarked for streamlined development and approval.