[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: 21CFR312.88]

[Page 81]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 312_INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
    Subpart E_Drugs Intended to Treat Life-threatening and Severely-
                         debilitating Illnesses
 
Sec. 312.88  Safeguards for patient safety.

    All of the safeguards incorporated within parts 50, 56, 312, 314, 
and 600 of this chapter designed to ensure the safety of clinical 
testing and the safety of products following marketing approval apply to 
drugs covered by this section. This includes the requirements for 
informed consent (part 50 of this chapter) and institutional review 
boards (part 56 of this chapter). These safeguards further include the 
review of animal studies prior to initial human testing (Sec. 312.23), 
and the monitoring of adverse drug experiences through the requirements 
of IND safety reports (Sec. 312.32), safety update reports during 
agency review of a marketing application (Sec. 314.50 of this chapter), 
and postmarketing adverse reaction reporting (Sec. 314.80 of this 
chapter).