Industry appears more excited about its success to date with the GDUFA self-identification process than disappointed by its initial failure. Executives say they are happy that nearly two-thirds of the expected generic drug facilities did in fact self-identify with FDA, instead of expressing concern that one-third missed the deadline, potentially raising the fees for everyone else.
The generic drug user fee program has not launched as smoothly as was hoped
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?