Transcription of Guidance for Industry
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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.
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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