[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.20]

[Page 61]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
          Subpart B--Investigational New Drug Application (IND)
 
Sec. 312.20  Requirement for an IND.


    (a) A sponsor shall submit an IND to FDA if the sponsor intends to 
conduct a clinical investigation with an investigational new drug that 
is subject to Sec. 312.2(a).
    (b) A sponsor shall not begin a clinical investigation subject to 
Sec. 312.2(a) until the investigation is subject to an IND which is in 
effect in accordance with Sec. 312.40.
    (c) A sponsor shall submit a separate IND for any clinical 
investigation involving an exception from informed consent under 
Sec. 50.24 of this chapter. Such a clinical investigation is not 
permitted to proceed without the prior written authorization from FDA. 
FDA shall provide a written determination 30 days after FDA receives the 
IND or earlier.

[52 FR 8831, Mar. 19, 1987, as amended at 61 FR 51529, Oct. 2, 1996; 62 
FR 32479, June 16, 1997]