Table 2

IND application table of contents

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)]


aOr completed form(s) FDA 1572.

Steinmetz and Spack BMC Neurology 2009 9(Suppl 1):S2   doi:10.1186/1471-2377-9-S1-S2

Open Data