FDA guidance on use of large simple trials would help encourage conduct of such studies in lieu of longer, more complex and costly randomized controlled trials, according to a recently released Institute of Medicine report.
Such guidance could help reduce the fear – which FDA asserts to be unfounded – among biopharmaceutical sponsors that the agency will request additional clinical data points beyond those generated...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?