Volume 7, Number 6—December 2001
Developing New Smallpox Vaccines
|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|FDA draft guidance for industry: revised preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease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.