Joint Meeting of
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
July 27, 2000
The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Aventis Pasteur, by Jeffrey Almond
FDA Briefing Information
List of Materials
Summary (Issue, Background, Charge, Questions)
(Chart) Recommended Childhood Immunization Schedule, United State, January-December 2000- Approved by the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP)
Letter from Gerald V. Quinan, Jr, Acting Director, FDA, Center for Biologics Evaluation and Reserach, "Dear Biologic Product Manufacturer," 3 May 1991
Letter from Jane Henney MD, Deputy Commissioner for Operations, FDA, to Manufacturers of FDA-Regulatored Products, December 17, 1993
Letter from Michael A Friedman, Deputy Commissioner for Operations, FDA, to Manufacturers of FDA-Regulated Drug/Biologic/Device Products, May 9, 1996.
Letter from Kathryn C Zoon, Director, FDA Center for Biologics Evaluation and Research, to Manufacturers of Biolocgical Products, April 19, 2000
Federal Register, Vol. 63, No. 3, Department of Agriculature, Animal and Plant Health Inspection Service, 9CFR Parts 94 and 96, Restrictuions on the Imporatation of Ruminants, Meat and Meat Products From Ruminants, and Certain Other Ruminant Products, January 6, 1998 (63FR406). pdf txt
Additional Reading (a listing)