Manufacturing Issues Delay Half Of Pending BLAs, CBER’s Yetter Says

Half of the active pending BLAs at the Office of Therapeutics Research & Review as of Jan. 1 have manufacturing concerns, Center for Biologics Evaluation & Research Associate Director-Review Management Robert Yetter, PhD, 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

More from Archive

More from Pink Sheet