21 CFR § 314.98 - Postmarketing reports.

---
identifier: "/us/cfr/t21/s314.98"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 314.98 - Postmarketing reports."
title_number: 21
title_name: "Food and Drugs"
section_number: "314.98"
section_name: "Postmarketing reports."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "314"
part_name: "APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 360ddd, 360ddd-1, 371, 374, 379e, 379k-1."
regulatory_source: "50 FR 7493, Feb. 22, 1985, unless otherwise noted."
cfr_part: "314"
---


# 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.

[79 FR 33089, June 10, 2014]