A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
In a boost for Big Pharma, the European Medicines Agency (EMA) has raised the fee-reduction rate for non-small and medium-sized enterprises (SMEs) seeking assistance on non-pediatric-related protocol from 40 percent to 75 percent, in line with recommendations by the agency’s orphan medicinal products panel.
Home » Events » Adaptive Clinical Trial Case Studies
In this 90-minute audio CD/transcript, Cyrus
Mehta, Ph.D., cofounder and president of Cytel Inc., will present three
in-depth case studies where an adaptive design was used to modify the
initial assumptions and improve the design, using interim data from the trial