21 CFR 314.445
§ 314.445 Guidance documents.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 314.445, § 314.445 Guidance documents, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86389
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Full text
(a) FDA has made available guidance documents under § 10.115 of this chapter to help you to comply with certain requirements of this part.
(b) The Center for Drug Evaluation and Research (CDER) maintains a list of guidance documents that apply to CDER's regulations. The list is maintained on the Internet and is published annually in the Federal Register. A request for a copy of the CDER list should be directed to the Office of Training and Communications, Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.