Biosimilar User Fee Meeting Schedule Allows FDA Data “Pre-Review”

Agency officials are willing to meet with sponsors during their development programs to look at data and provide advice in part to ensure they remain on track, but also to promote a high first-cycle approval rate.

Biosimilar sponsors can expect FDA to actively participate in development programs long before a marketing application is filed, in part to help sponsors avoid costly and time-consuming missteps.

Five meeting types are included in the biosimilar user fee program for sponsors to receive advice and have questions answered...

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

More from United States

More from North America