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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER F: BIOLOGICS
PART 601: LICENSING
Subpart C: Biologics Licensing
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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