A competitive generic therapy designation alone will not guarantee a shorter assessment goal by US FDA, just a promise to finish as soon as possible.
The agency is willing to expedite its assessment of applications receiving the designation designed to encourage more generic entry in markets where there is inadequate competition. But the agency said...
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?