CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG > SUBPART C—Abbreviated Applications (§314.92 to §314.99) > 314.98—Postmarketing reports.

314.98—Postmarketing reports.

(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 Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266.
(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.

Code of Federal Regulations

[57 FR 17983, Apr. 28, 1992, as amended at 64 FR 401, Jan. 5, 1999; 74 FR 13113, Mar. 26, 2009]