ABSTRACT
What Is an IND? ................................................................................................. 42 When Do I Need an IND? .............................................................................. 42 When Don’t I Need an IND? ......................................................................... 43
Pre-IND Meeting ................................................................................................ 45 The Content and Format of an IND Application ................................................ 46
Cover Sheet-Section 312.23(a)(1) Form FDA 1571-IND......................... 46 Table of Contents-Section 312.23(a)(2) ...................................................... 50 Introductory Statement and General Investigational Plan-Section 312.23(a)(3) ........................................................................... 50 Investigator’s Brochure-Section 312.23(a)(5) ............................................. 51 Clinical Protocol-Section 312.23(a)(6) ....................................................... 52 CMC Information-Section 312.23(a)(7) ...................................................... 53 Pharmacology and Toxicology Information-Section 312.23(a)(8) .............. 59 Previous Human Experience-Section 312.23(a)(9) ..................................... 61 Additional Information-Section 312.23(a)(10) ........................................... 62 Relevant Information-Section 312.23(a)(11)............................................... 62 Other Important Information about the Submission of an IND ..................... 62 Electronic Submissions .................................................................................. 65 FDA Review of the IND ................................................................................. 66
Maintaining an IND-IND Amendments and Other Required Reports ............. 66 The IND Safety Report .................................................................................. 67 The Protocol Amendment .............................................................................. 69 Information Amendments............................................................................... 71 IND Annual Reports ....................................................................................... 71
Other Types of INDs ........................................................................................... 72 Promotion and Charging for Investigational Drugs ............................................ 73
Promotion of Investigational Drug Products .................................................. 73 Charging for Investigational Drugs ................................................................ 74
More Information about INDs ............................................................................ 74 The FDA Websites ......................................................................................... 74 Other Websites ............................................................................................... 75
References ........................................................................................................... 75
The Federal Food, Drug, and Cosmetic (FD&C) Act requires that all new drugs have an approved marketing application [new drug application (NDA) or biologics license application (BLA)] before they can be shipped in interstate commerce. An IND, or investigational new drug application, is a submission to the US Food and Drug Administration (FDA) requesting permission to initiate a clinical study of a new drug product in the United States. From a legal perspective, the IND is a request for exemption from the Act that prohibits from introducing any new drug into interstate commerce without an approved application. The IND allows you to legally ship an unapproved drug, or import a new drug from a foreign country.
