Division of Clinical Research

Office of the Vice President and Innovation

The following FDA webinar is FREE and offers SOCRA CE!

Regulatory Perspectives for Development of Drugs for Treatment of NASH

January 29, 2021 | 1:00 – 2:30 PM Eastern

Register here: https://www.fda.gov/drugs/news-events-human-drugs/regulatory-perspectives-development-drugs-treatment-nash-01292021-01292021?utm_medium=email&utm_source=govdelivery

FDA will provide a summary of FDA’s current thinking on the published draft guidance documents: Non-cirrhotic Non-alcoholic Steatohepatitis (NASH): Developing Drugs for Treatment, and Non-alcoholic Steatohepatitis in Compensated Cirrhosis: Developing Drugs for Treatment.

TOPICS

  • Phase 2 drug development for NASH
  • Clinical trial inclusion/exclusion for phase 3 NASH trials
  • Surrogate efficacy endpoints that have been acknowledged by FDA as reasonably likely to predict clinical benefit
  • Clinical endpoints for the confirmation of clinical benefit
  • Strategies at clinical drug development for NASH

LEARNING OBJECTIVES
After this webinar, participants will be able to…

  • Confirm the reasons why NASH is a serious condition as defined in 21 CFR regulation.
  • Understand the importance of early clinical development and proof-of-concept trials.
  • Describe the rationale for the choice of the surrogate endpoint reasonably likely to predict clinical benefit.
  • Describe the endpoints used to characterize the confirmation of clinical benefit.
Categories FDA Regulatory
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