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 |