part_subject: "APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG"
subpart_code: "G"
subpart_subject: "Miscellaneous Provisions"
section_number: "314.445"
section_subject: "Guidance documents."
cfr_reference: "21 CFR 314.445"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 300 to 499"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.