[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: 21CFR601.46]

[Page 42]
 
                        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. 601.46  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.