[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.80]

[Page 79-80]
 
                        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 E_Drugs Intended to Treat Life-threatening and Severely-
                         debilitating Illnesses
 
Sec. 312.80  Purpose.

    Authority: 21 U.S.C. 351, 352, 353, 355, 371; 42 U.S.C. 262.

    Source: 53 FR 41523, Oct. 21, 1988, unless otherwise noted.


    The purpose of this section is to establish procedures designed to 
expedite the development, evaluation, and marketing of new therapies 
intended to treat persons with life-threatening and severely-
debilitating illnesses, especially where no satisfactory alternative 
therapy exists. As stated Sec. 314.105(c) of this chapter, while the 
statutory standards of safety and effectiveness apply to all drugs, the 
many kinds of drugs that are subject to them, and the wide range of uses 
for those drugs, demand flexibility in applying the standards. The Food 
and

[[Page 80]]

Drug Administration (FDA) has determined that it is appropriate to 
exercise the broadest flexibility in applying the statutory standards, 
while preserving appropriate guarantees for safety and effectiveness. 
These procedures reflect the recognition that physicians and patients 
are generally willing to accept greater risks or side effects from 
products that treat life-threatening and severely-debilitating 
illnesses, than they would accept from products that treat less serious 
illnesses. These procedures also reflect the recognition that the 
benefits of the drug need to be evaluated in light of the severity of 
the disease being treated. The procedure outlined in this section should 
be interpreted consistent with that purpose.