Title 21: Food and Drugs
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/ PART 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
/ Subpart C - Abbreviated Applications / § 314.98 Postmarketing reports.
§ 314.98 Postmarketing reports.
(a) Each applicant having an approved abbreviated new drug application under § 314.94 that is effective must comply with the requirements of § 314.80 regarding the reporting and recordkeeping of adverse drug experiences.
(b) Each applicant must make the reports required under § 314.81 and section 505(k) of the Federal Food, Drug, and Cosmetic Act for each of its approved abbreviated applications.