[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: 21CFR312.80]

[Page 79-80]
 
                        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. 312.80  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 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

[[Page 80]]

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.