FDA has nearly scaled the mountain of ANDAs in the generic drug user fee program backlog, but could wind up climbing the mountain a second time because most may require another review.
At the end of 2015, the agency's Office of Generic Drugs completed what are known as first actions on 84%...
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?