[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: 21CFR314.97]

[Page 127]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents
 
                   Subpart C--Abbreviated Applications
 
Sec. 314.97  Supplements and other changes to an approved abbreviated application.

    The applicant shall comply with the requirements of Secs. 314.70 and 
314.71 regarding the submission of supplemental applications and other 
changes to an approved abbreviated application.