[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.46]

[Page 39]
 
                        TITLE 21--FOOD AND DRUGS
 
          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. 601.46  Termination of requirements.

    If FDA determines after approval that the requirements established 
in Sec. 601.42, Sec. 601.43, or Sec. 601.45 are no longer necessary for 
the safe and effective use of a biological product, it will so notify 
the applicant. Ordinarily, for biological products approved under 
Sec. 601.41, these requirements will no longer apply when FDA determines 
that the required postmarketing study verifies and describes the 
biological product's clinical benefit and the biological product would 
be appropriate for approval under traditional procedures. For biological 
products approved under Sec. 601.42, the restrictions would no longer 
apply when FDA determines that safe use of the biological product can be 
assured through appropriate labeling. FDA also retains the discretion to 
remove specific postapproval requirements upon review of a petition 
submitted by the sponsor in accordance with Sec. 10.30.