Volume 7, Number 6—December 2001
Perspective
Developing New Smallpox Vaccines
Steven R. Rosenthal
, Michael Merchlinsky, Cynthia Kleppinger, and Karen L. Goldenthal
, Michael Merchlinsky, Cynthia Kleppinger, and Karen L. Goldenthal
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| FDA draft guidance for industry: revised preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease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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