[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.90]

[Page 45]
 
                        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 H_Approval of Biological Products When Human Efficacy Studies 
                       Are Not Ethical or Feasible
 
Sec. 601.90  Scope.

    Source: 67 FR 37996, May 31, 2002, unless otherwise noted.


    This subpart applies to certain biological products that have been 
studied for their safety and efficacy in ameliorating or preventing 
serious or life-threatening conditions caused by exposure to lethal or 
permanently disabling toxic biological, chemical, radiological, or 
nuclear substances. This subpart applies only to those biological 
products for which: Definitive human efficacy studies cannot be 
conducted because it would be unethical to deliberately expose healthy 
human volunteers to a lethal or permanently disabling toxic biological, 
chemical, radiological, or nuclear substance; and field trials to study 
the product's efficacy after an accidental or hostile exposure have not 
been feasible. This subpart does not apply to products that can be 
approved based on efficacy standards described elsewhere in FDA's 
regulations (e.g., accelerated approval based on surrogate markers or 
clinical endpoints other than survival or irreversible morbidity), nor 
does it address the safety evaluation for the products to which it does 
apply.