[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.83]

[Page 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. 312.83  Treatment protocols.

    If the preliminary analysis of phase 2 test results appears 
promising, FDA may ask the sponsor to submit a treatment protocol to be 
reviewed under the procedures and criteria listed in Secs. 312.34 and 
312.35. Such a treatment protocol, if requested and granted, would 
normally remain in effect while the complete data necessary for a 
marketing application are being assembled by the sponsor and reviewed by 
FDA (unless grounds exist for clinical hold of ongoing protocols, as 
provided in Sec. 312.42(b)(3)(ii)).