[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.40]

[Page 37]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 601--LICENSING--Table of Contents
 
 Subpart E--Accelerated Approval of Biological Products for Serious or 
                       Life-Threatening Illnesses
 
Sec. 601.40  Scope.

    Source: 57 FR 58959, Dec. 11, 1992, unless otherwise noted.


    This subpart applies to certain biological products that have been 
studied for their safety and effectiveness in treating serious or life-
threatening illnesses and that provide meaningful therapeutic benefit to 
patients over existing treatments (e.g., ability to treat patients 
unresponsive to, or intolerant of, available therapy, or improved 
patient response over available therapy).