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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Unformatted text preview: 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Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Submit comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance.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Drug Evaluation and Research Center for Veterinary Medicine September 2003 Contains Nonbinding Recommendations Draft — Not for Implementation Guidance for Industry Comparability Protocols Protein Drug Products and Biological Products - - Chemistry, Manufacturing, and Controls Information Additional copies of this guidance are available from: Office of Communication, Training, and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 800-835-4709 or 301-827-1800 Internet: http://www.fda.gov/cber/guidelines.htm or Division of Drug Information, HFD-240 Center for Drug Evaluation and Research 5600 Fishers Lane, Rockville, MD 20857 Phone: 301-827-4573 Internet: http://www.fda.gov/cder/guidance/index.htm or Communications Staff, HFV-12 Center for Veterinary Medicine (CVM) 7519 Standish Place Rockville, MD 20855 Phone: 301-827-3800 Internet at http://www.fda.gov/cvm/guidance/published.htm 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Drug Evaluation and Research Center for Veterinary Medicine September 2003 Contains Nonbinding Recommendations Draft — Not for Implementation ii TABLE OF CONTENTS I. INTRODUCTION ................................................................................................................1 II. BACKGROUND...............................................................................................................2 A. What is a Comparability Protocol? ....................................................................................4 B. What is the Benefit of Using a Comparability Protocol? ..................................................4 C. When and Why Were Comparability Protocols Created?.................................................4 D. Why is A Guidance on Comparability Protocols Being Provided?...................................5 E. Where Can More Information on Postapproval Changes and Assessment of Comparability Be Found?..........................................................................................................5Comparability Be Found?...
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This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at UGA.

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

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