2000D-1400
BKG 1
Volume 1

Reference List

Reference 1 - Transcript for Workshop: Non-Clinical Safety Evaluation of Preventive Vaccines: Recent Advances and Regulatory Considerations, Volume II (Volume I is irrelevant to the guidance). Part 2, Part 3

Reference 2 - International Conference on Harmonization (ICH) Harmonized Tripartite Guideline for Industry (ICH-S5A) Detection of Toxicity to Reproduction for Medicinal Products, (59 FR 48746, September 22, 1994), http://www.fda.gov/cder/guidance/s5a.pdf

Reference 3 - Recommended adult immunization schedule - United States, 2002-2003, MMWR October 11, 2002, Vol. 51 (40); 904-908.

Reference 4 - Colley, Gilbert B., Brantley, M.D., Larson, M.K., Family Planning Practices and Pregnancy Intention, 1997. Atlanta, GA: Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 2000. Part 2, Part 3, Part 4 http://www.cdc.gov/reproductivehealth/prams/pdf/97/PRAMS_sr_97.pdf

Reference 5 - Barrow, P.C ., Reproductive toxicology studies and immunotherapeutics . Toxicology 185 (2003), 205-212. Published Material

Reference 6 - Thellin, O., Heinen, E., Pregnancy and the immune system: between tolerance and rejection. Toxicology 185 (2003), 179-184. Published Material

Reference 7 - Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product (January 1999), http://www.fda.gov/cber/gdlns/cmcvacc.pdf