Upcoming prescription drug user fee renewal legislation still may include some form of expansion for FDA’s accelerated approval program, but the early nature of the current proposals suggests major work is needed to get the reforms added to the bill.
Draft language being circulated by the Biotechnology Industry Organization would add more detail on specific types of non-traditional evidence to the accelerated approval regulation.
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?