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. Author manuscript; available in PMC: 2016 Apr 1.
Published in final edited form as: Cytotherapy. 2014 Dec 4;17(4):339–343. doi: 10.1016/j.jcyt.2014.10.008

  • Cover Sheet (Form FDA 1571)

  • Cover Memo

  • Statement of Investigator (Form FDA 1572)

  • Table of Contents

  • Introductory Statement

  • General Investigational Plan

  • Investigator Brochure

  • Protocol

  • Referencing Other Sources

  • Introduction

  • Drug Substance

  • Drug Product

  • Placebo

  • Labeling

  • Environmental Impact

  • Pharmacology and Toxicology Information

  • Responsible Individuals

  • GLP Compliance Certificate

  • Chemistry, Manufacturing and Controls

  • Pharmacology and Drug Distribution

  • Toxicology: Integrated Summary

  • Toxicology: Full Data Tabulation

  • Previous Human Experience

  • Additional Information

  • Other FDA-Requested Information

  • Certification of Compliance (Form FDA 3674)