21 CFR 601.29
§ 601.29 Guidance documents.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 601.29, § 601.29 Guidance documents, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88332
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Full text
(a) FDA has made available guidance documents under § 10.115 of this chapter to help you comply with certain requirements of this part.
(b) The Center for Biologics Evaluation and Research (CBER) maintains a list of guidance documents that apply to the center's regulations. The lists are maintained on the Internet and are published annually in the Federal Register. You may request a copy of the CBER list from the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Communication, Outreach and Development, 10903 New Hampshire Ave., Bldg. 71, Rm. 3103, 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.