21 CFR 314.445 – Guidance documents
Current as of: 2024 | Check for updates
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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