| | | | | | | | | | |
|
| |
|
| Dockets Entered
On May 4, 2006
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1997S-0163
|
| Dietary Supplements, Courtesy Letters (Letters of Objection)
|
|
|
|
|
| 1999F-5321
|
| Food Safety & Inspection service safe use of ionizing radiai
|
|
|
|
|
| 1999F-5322
|
| Ionizing Radiation for the Treatment of Food
|
|
|
|
|
| 1999F-5522
|
| Ionizing radiation /control of Food-borne pathogens safe use
|
|
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
|
|
|
|
| 2001F-0047
|
| Foodborne pathogens in raw-frozen-cooked-partially cooked
|
|
|
|
|
| 2003P-0544
|
| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
|
|
|
|
|
| 2003V-0426
|
| Laser Light Show
|
|
|
|
|
| 2005N-0437
|
| Medical Gas Containers and Closures; Current Good Manufacturing
|
|
|
|
|
| 2005P-0282
|
| Require Health Messages on Soft Drinks
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| 2005P-0456
|
| Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons
|
|
|
|
|
| 2006P-0117
|
| ANDA Suitability for Omeprazole Tablets, 20 mg (proposed formulation)
|
|
|
|
|
| 2006P-0144
|
| delalutin hydroxyprogesterone caproate) Injection was not withdrawn for safety or effectiveness reasons and therefore suibable for ANDA
|
|
|
|
|
| 2006P-0145
|
| ANDA suitability for Gemcitabine
|
|
|
|
|
| 1997S-0163
|
| Dietary Supplements, Courtesy Letters (Letters of Objection)
|
|
|
|
|
| LET 876
|
| FDA/CFSAN to Sedona Laboratoreis Inc
|
| Vol #:
|
| 26
|
|
|
|
|
| LET 877
|
| FDA/CFSAN to Market America
|
| Vol #:
|
| 26
|
|
|
|
|
| LET 878
|
| FDA/CFSAN to Robinson Outdoor Products
|
| Vol #:
|
| 26
|
|
|
|
|
| LET 879
|
| FDA/CFSAN to USANA Health Sciences Inc
|
| Vol #:
|
| 26
|
|
|
|
|
| LET 880
|
| FDA/CFSAN to Phoenix Biologics Inc
|
| Vol #:
|
| 26
|
|
|
|
|
| LET 881
|
| FDA/CFSAN to CV Technologies Inc
|
| Vol #:
|
| 26
|
|
|
|
|
| LET 882
|
| FDA/CFSAN to Nutrition 21, Inc
|
| Vol #:
|
| 26
|
|
|
|
|
| LET 883
|
| FDA/CFSAN to Davisco Foods International Inc
|
| Vol #:
|
| 26
|
|
|
|
|
| LET 884
|
| FDA/CFSAN to Gindan Neutra-Ceuticals Inc
|
| Vol #:
|
| 26
|
|
|
|
|
| 1999F-5321
|
| Food Safety & Inspection service safe use of ionizing radiai
|
|
|
|
|
| C 82
|
| The Center for Food Safety (CFS) and Food & Water Watch (FWW)
|
| Vol #:
|
| 8
|
|
|
|
|
| 1999F-5322
|
| Ionizing Radiation for the Treatment of Food
|
|
|
|
|
| C 81
|
| The Center for Food Safety (CFS) and Food & Water Watch (FWW)
|
| Vol #:
|
| 6
|
|
|
|
|
| 1999F-5522
|
| Ionizing radiation /control of Food-borne pathogens safe use
|
|
|
|
|
| C 98
|
| The Center for Food Safety (CFS) and Food & Water Watch (FWW)
|
| Vol #:
|
| 10
|
|
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
| | | | | | | | |
|
| |
|
| C 18266
|
| L. Calkins
|
| Vol #:
|
| 516
|
|
|
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
|
|
|
|
| C 12860
|
| L. Calkins
|
| Vol #:
|
| 806
|
|
| |
|
| 2001F-0047
|
| Foodborne pathogens in raw-frozen-cooked-partially cooked
|
|
|
|
|
| C 80
|
| The Center for Food Safety (CFS) and Food & Water Watch (FWW)
|
| Vol #:
|
| 8
|
|
|
|
|
| 2003P-0544
|
| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
|
|
|
|
|
| C 58
|
| The Center for Food Safety (CFS) and Food & Water Watch (FWW)
|
| Vol #:
|
| 5
|
|
|
|
|
| 2003V-0426
|
| Laser Light Show
|
|
|
|
|
| EXP 1
|
| Celebration City
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0437
|
| Medical Gas Containers and Closures; Current Good Manufacturing
|
|
|
|
|
| BKG 1
|
| Background Material
|
| Vol #:
|
| 2
|
|
|
|
|
| 2005P-0282
|
| Require Health Messages on Soft Drinks
|
|
|
|
|
| C 25
|
| N. Werner
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| C 8127
|
| R. Paulsen
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8128
|
| E. Mirbach
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8129
|
| E. Engstrom
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8130
|
| A. Gilleh
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8131
|
| R. E. Tutle
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8132
|
| J. Coitti
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8133
|
| B. Dubbina
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8134
|
| A. Mackichan
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8135
|
| M. Moreno
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8136
|
| H. H. Covault
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8137
|
| R. Riddick
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8138
|
| S. S. Kiker
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8139
|
| M. A. DuBois
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8140
|
| J. Lewis
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8141
|
| P. S. Johnson
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8142
|
| D. K. Bruce
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8143
|
| N. Neilsen
|
| Vol #:
|
| 120
|
|
|
|
|
| C 8144
|
| P. A. Vath
|
| Vol #:
|
| 120
|
|
