• NDA
  • ANDA
  • OTCs
  • NDA/BLA Biologics & Biosimilars

FDA Expedited Pathways

  • RMAT
  • Orphan Drug
  • Fast Track
  • Breakthrough Therapy
  • Priority Review
  • Emergency Use Authorization
  • Accelerated Approval Program

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.