1. Pink Sheet

Generic Drug Assessment Times Show Improvement In GDUFA Performance Report

 
• By Derrick Gingery

Averages likely will increase as more of the cohort is approved, however.

FDA Approved typed words on a vintage typewriter
Average generic drug application approval times decreased throughout the first five-year GDUFA program cycle. • Source: Shutterstock

Generic drug application approval times dropped substantially during the first user fee program cycle, suggesting the US Food and Drug Administration and sponsors are making progress streamlining the process.

The average time to a first-cycle ANDA approval decreased nearly 73% from fiscal year 2013 to fiscal year 2017 and is showing signs of a continued decline

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
Start Free Trial

Already a subscriber?

More from Generics

More from Biosimilars & Generics