The US FDA did not approve any priority assessment ANDAs in fiscal year 2018, but did push a few applications through another expedited pathway, signaling that industry may not fully understand the new system intended to help speed generic drugs to market.
Priority assessments were introduced in 2017 as part of the FDA Reauthorization Act
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?