---
kind: "section"
citation: "21 C.F.R. § 314.98"
title: "21"
number: "314.98"
heading: "Postmarketing reports."
url: "https://uscodex.org/cfr/21/314.98"
---

# §314.98. Postmarketing reports.

- (a) Each applicant having an approved abbreviated new drug application under [§ 314.94](/cfr/21/314.94.md) that is effective must comply with the requirements of [§ 314.80](/cfr/21/314.80.md) regarding the reporting and recordkeeping of adverse drug experiences.
- (b) Each applicant must make the reports required under [§ 314.81](/cfr/21/314.81.md) and [section 505(k)](/cfr/21/505.md?p=k) of the Federal Food, Drug, and Cosmetic Act for each of its approved abbreviated applications.

## Notes

### Amendments

[79 FR 33089, June 10, 2014]

### Source

Source: 57 FR 17983, Apr. 28, 1992, unless otherwise noted.

### Authority

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.

### Source

Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.

### Amendments

[79 FR 33089, June 10, 2014]