[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: 21CFR601.95]

[Page 47]
 
                        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. 601.95  Termination of requirements.

    If FDA determines after approval under this subpart that the 
requirements established in Sec. Sec. 601.91(b)(2), 601.92, and 601.93 
are no longer necessary for the safe and effective use of a biological 
product, FDA will so notify the applicant. Ordinarily, for biological 
products approved under Sec. 601.91, these requirements will no longer 
apply when FDA determines that the postmarketing study verifies and 
describes the biological product's clinical benefit. For biological 
products approved under Sec. 601.91, the restrictions would no longer 
apply when FDA determines that safe use of the biological product can be 
ensured 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 of this chapter.