Joint Meeting of
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE
and
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
July 27, 2000
SmithKline Beecham
Disclaimer
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)