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21 C.F.R. § 601.29   Guidance documents.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 601—LICENSING
Subpart C—Biologics Licensing

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§ 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).

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

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