Speaking Engagement

Exploring the Expedited Approval Process: Applicability and Eligibility

ACI's 35th FDA Boot Camp

23 Mar 2020 10:30 a.m. - 11:15 a.m.

DoubleTree By Hilton Metropolitan
569 Lexington Ave
New York, NY 10022

Register


Bethany Hills is speaking at the FDA bootcamp in NYC in March.

  • Understanding accelerated approval, breakthrough therapy, surrogate end points, and biomarkers
  • Reviewing the different pathways for expedited approval
    • Evaluating the criteria for each pathway
    • Weighing the pros and cons of each pathway
  • Factoring expedited approval into your drug development strategy
  • Discussing the limitations that exist for orphan and breakthrough drugs
  • Obtaining waivers for rare diseases

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