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Table 2 IND application table of contents

From: The basics of preclinical drug development for neurodegenerative disease indications

1 Form FDA 1571 [21 CFR 312.23(a)(1)]
2 Table of contents [21 CFR 312.23(a)(2)]
3 Introductory statement [21 CFR 312.23(a)(3)]
4 General investigational plan [21 CFR 312.23(a)(3)]
5 Investigator's brochure [21 CFR 312.23(a)(5)]
6 Protocol(s) [21 CFR 312.23(a)(6)]
     a. Study protocols [21 CFR 312.23(a)(6)]
     b. Investigator data [21 CFR 312.23(a)(6)(iii)(b)]a
     c. Institutional review board data [21 CFR 312.23(a)(6)(iii)(b)]a
7 Chemistry, manufacturing, and control data [21 CFR 312.23(a)(7)]
8 Pharmacology and toxicology data [21 CFR 312.23(a)(8)]
9 Previous human experience [21 CFR 312.23(a)(8)]
10 Additional information [21 CFR 312.23(a)(10)]
  1. aOr completed form(s) FDA 1572.