Title 21: Food and Drugs
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/ PART 601 - LICENSING
/ Subpart C - Biologics Licensing / § 601.29 Guidance documents.
§ 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