View all text of Subpart C [§ 601.12 - § 601.29]
§ 601.29 - Guidance documents.
(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