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Guidance for Industry

Guidance for Industry Cooperative Manufacturing Arrangements for Licensed Biologics Additional copies of this Guidance are available from the Office of Communication, Training and Manufacturers Assistance (OCTMA) (HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1448 or by calling 1-800-835-4709 or 301-827-1800, or from the Internet at For questions on the content of this Guidance , contact OCTMA (Center for Biologics Evaluation and Research) at the phone numbers listed above and the Office of Pharmaceutical Science (Center for Drug Evaluation and Research) at 301-796-2400. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Center for Drug Evaluation and Research November 2008 OMB Control No. 0910-0629 Expiration Date: 04/30/2021 See additional PRA statement in Section VII of this Guidance Contains Nonbinding Recommendations Guidance for Industry Cooperative Manufacturing Arrangements for Licensed Biologics Additional copies of this Guidance are available from: Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448 Phone: 800-835-4709 or 301-827-1800 Internet: or Office of Training and Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administ

Guidance for Industry . Cooperative Manufacturing Arrangements for Licensed Biologics . Additional copies of this guidance are available from the Office of Communication, Training and

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