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 Federal Register. You may request a copy of the CBER list from the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration (see mailing addresses in § 600.2 of this chapter ).

Code of Federal Regulations

[65 FR 56480, Sept. 19, 2000, as amended at 70 FR 14984, Mar. 24, 2005]

CFR

601.29—Guidance documents.

Code of Federal Regulations