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Volume 7, Number 6—December 2001

Perspective

Developing New Smallpox Vaccines

Steven R. RosenthalComments to Author , Michael Merchlinsky, Cynthia Kleppinger, and Karen L. Goldenthal
Author affiliations: Food and Drug Administration, Rockville, Maryland, USA

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Table A1

Examples of U.S. Food and Drug Administration and International Conference on Harmonization (ICH) Documents Relevant to the Manufacture and Product Quality of New Smallpox Vaccines

Title Date
FDA points to consider in the characterization of cell lines used to produce biologicals 1993
ICH guidance on quality of biotechnological/biological products: derivation and characterization of cell substrates used for production of biotechnological/ biological products 1998
ICH guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin 1998
FDA guidance for industry: content and format of chemistry, manufacturing and controls information and establishment description information for a vaccine or related product 1999
FDA draft guidance for industry: revised preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by blood and blood products 2001

To obtain these documents, connect to http://www.fda.gov/cber/guidelines.htm or call the FDA Office of Communication, Training and Manufacturers Assistance at 1-800-835-4709.

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