Regulatory Considerations for Microbiome Based Therapeutics

Time: 5:25 pm
day: Day Two

Details:

  • Investigational New Drug Applications (INDs)
  • Additional Chemistry, Manufacturing and Controls (CMC) considerations for INDs with:
  1. Fecal Microbiota Transplantation (FMT)
  2. Live Biotherapeutic Products (LBPs)
  • COVID testing for FMT donors

Speakers: