Docket No.: 1980N-0208 (formerly 80N-0208)

Title: Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Withdrawal

Reference

TABLE OF CONTENTS

Tab #
Reference Title
1
January 5, 2004, Biological Products; Bacterial Vaccines and Toxoids; Implementaiton of Efficacy Review; Final rule and final order htm pdf
2
January 8, 2004, January 5, 2004, Biological Products; Bacterial Vaccines and Toxoids; Implementaiton of Efficacy Review; Correction htm pdf
3
February 13, 2004, Products; Bacterial Vaccines and Toxoids; Implementaiton of Efficacy Review; Correction htm pdf
4
October 27, 2004, Court issued a memorandum opinion vacating and remanding the January 2004 final rule and final order to FDA for reconsideration pdf