[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.22]

[Page 54-55]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 312_INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
          Subpart B_Investigational New Drug Application (IND)
 
Sec. 312.22  General principles of the IND submission.

    (a) FDA's primary objectives in reviewing an IND are, in all phases 
of the investigation, to assure the safety and rights of subjects, and, 
in Phase 2 and 3, to help assure that the quality of the scientific 
evaluation of drugs is adequate to permit an evaluation of the drug's 
effectiveness and safety. Therefore, although FDA's review of Phase 1 
submissions will focus on assessing the safety of Phase 1 
investigations, FDA's review of Phases 2 and 3 submissions will also 
include an assessment of the scientific quality of the clinical 
investigations and the likelihood that the investigations will yield 
data capable of meeting statutory standards for marketing approval.
    (b) The amount of information on a particular drug that must be 
submitted in an IND to assure the accomplishment of the objectives 
described in paragraph (a) of this section depends upon such factors as 
the novelty of the drug, the extent to which it has been studied 
previously, the known or suspected risks, and the developmental phase of 
the drug.
    (c) The central focus of the initial IND submission should be on the 
general investigational plan and the protocols for specific human 
studies. Subsequent amendments to the IND that contain new or revised 
protocols should build logically on previous submissions and should be 
supported by additional information, including the results of animal 
toxicology studies or other human studies as appropriate. Annual

[[Page 55]]

reports to the IND should serve as the focus for reporting the status of 
studies being conducted under the IND and should update the general 
investigational plan for the coming year.
    (d) The IND format set forth in Sec. 312.23 should be followed 
routinely by sponsors in the interest of fostering an efficient review 
of applications. Sponsors are expected to exercise considerable 
discretion, however, regarding the content of information submitted in 
each section, depending upon the kind of drug being studied and the 
nature of the available information. Section 312.23 outlines the 
information needed for a commercially sponsored IND for a new molecular 
entity. A sponsor-investigator who uses, as a research tool, an 
investigational new drug that is already subject to a manufacturer's IND 
or marketing application should follow the same general format, but 
ordinarily may, if authorized by the manufacturer, refer to the 
manufacturer's IND or marketing application in providing the technical 
information supporting the proposed clinical investigation. A sponsor-
investigator who uses an investigational drug not subject to a 
manufacturer's IND or marketing application is ordinarily required to 
submit all technical information supporting the IND, unless such 
information may be referenced from the scientific literature.