[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: 21CFR312.38]

[Page 74]
 
                        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. 312.38  Withdrawal of an IND.

    (a) At any time a sponsor may withdraw an effective IND without 
prejudice.
    (b) If an IND is withdrawn, FDA shall be so notified, all clinical 
investigations conducted under the IND shall be ended, all current 
investigators notified, and all stocks of the drug returned to the 
sponsor or otherwise disposed of at the request of the sponsor in 
accordance with Sec. 312.59.
    (c) If an IND is withdrawn because of a safety reason, the sponsor 
shall promptly so inform FDA, all participating investigators, and all 
reviewing Institutional Review Boards, together with the reasons for 
such withdrawal.

(Collection of information requirements approved by the Office of 
Management and Budget under control number 0910-0014)

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987]