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Guidance for Industry - Comparability protocols - Protein drug products and biological products - ch

Guidance for Industry - Comparability protocols - Protein drug products and biological products - ch

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Guidance for Industry Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Submit comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact Christopher Joneckis (CBER) 301-435-5681, Stephen Moore (CDER) 301-827-6430, or Dennis Bensley (CVM) 301-827-6956. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Center for Veterinary Medicine September 2003
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