[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.98]

[Page 134]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 314_APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--
Table of Contents
 
                   Subpart C_Abbreviated Applications
 
Sec. 314.98  Postmarketing reports.

    (a) Except as provided in paragraph (b) of this section, each 
applicant having an approved abbreviated new drug application under 
Sec. 314.94 that is effective shall comply with the requirements of 
Sec. 314.80 regarding the reporting and recordkeeping of adverse drug 
experiences.
    (b) Each applicant shall submit one copy of each report required 
under Sec. 314.80 to the Division of Epidemiology and Surveillance 
(HFD-730), Center for Drug Evaluation and Research, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857.
    (c) Each applicant shall make the reports required under Sec. 
314.81 and section 505(k) of the act for each of its approved 
abbreviated applications.

[57 FR 17983, Apr. 28, 1992, as amended at 64 FR 401, Jan. 5, 1999]