You Just Have To Wait: FDA Can't Hurry PDUFA VI Guidances

In response to stakeholder concern about multi-year schedule for patient-input guidance development, FDA says it only has a few experts and has to balance their time.

PDUFA VI letter

FDA had to remind stakeholders that drug development guidance is not easily written and in-house expertise has many demands on its time, even when user fee funds are supporting the projects.

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 Clinical Trials

More from R&D