21 CFR 314.98
§ 314.98 Postmarketing reports.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 314.98, § 314.98 Postmarketing reports, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86353
- Permanent ID
ys:prov:86353@1- SHA-256
977a223c3f194ced54072ee1b81ca39f7a3c80bbb6c5fc417c96f6df891f480b
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.