21 C.F.R. § 314.98 Postmarketing reports.
Title 21 - Food and Drugs
(a) Except as provided in paragraph (b) of this section, each applicant having an approved abbreviated new drug application under §314.94 that is effective shall comply with the requirements of §314.80 regarding the reporting and recordkeeping of adverse drug experiences. (b) Each applicant shall submit one copy of each report required under §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 §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]
Title 21: Food and Drugs
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart C—Abbreviated Applications
§ 314.98 Postmarketing reports.
