FDA Provides Guidance to Identify Gaps in Development Plan

Project Description

Drs. Michael Matthay and Kathleen Liu describe their experience in taking a novel stem cell therapy for acute lung injury into clinical trials. Their work, in collaboration with Drs. Jae Woo Lee and Carolyn Calfee, produced compelling efficacy and safety data. However, early interactions with the FDA and guidance from Catalyst Awards adviser, Dr. David Savello, provided valuable insights that guided their research approach which have resulted in the approval to initiate a Phase I clinical study. Sign up to receive updates on videos that highlight their work and other passionate researchers at UC San Francisco.

Project Details

  • Date June 21, 2013
  • Tags Development Plan

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