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| Dockets Entered
On February 10, 2005
Table of Contents
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| Docket #
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| Title
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| 1978N-0301
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| OTC External Analgesic Drug Products
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 1984V-0380
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| Variance 21CFR 1020.32 RE: source skin distance mininums
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2000N-0504
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| Egg Safety Action Plan
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2000V-1261
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| FluoroScan Premier mini C-Arm
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| 2004D-0465
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| Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
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| 2004D-0493
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| Draft Guidance for Industry on Recommended Approaches to Integration of Genetic Toxicology Study Results
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| 2004G-0381
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| Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004N-0535
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| Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
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| 2004N-0559
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| Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
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| 2004P-0060
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| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
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| 2004P-0298
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| Nutrient Content Claims for the Carbohydrate Content of Food
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| 2004P-0299
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| Nutrient Content Claims for Carbohydrates
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| 2004P-0522
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| Off label drug use for CYTOTEC
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| 2005M-0055
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| P930016/S017, STAR S4 Excimer Laser System with Variable Spot Scanning (VSS) and WaveScan WaveFront System, Approved 12/14/04
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| 2005N-0036
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| Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 2005P-0060
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| Hydrochlorothiazide Tablets 12.5 mg, is suitable for submission in an ANDA
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| 2005P-0061
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| Determine wheather the listed drug has been withdrawn for safety or effeftiveness reason
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| 1978N-0301
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| OTC External Analgesic Drug Products
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| LET
91
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| Hobart Laboratories, Inc. (Hobart)
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| Vol #:
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| 105
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| C
6
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| Protecting Our Guardians
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| Vol #:
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| 3
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| 1984V-0380
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| Variance 21CFR 1020.32 RE: source skin distance mininums
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| EXP
3
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| Hologic, Inc.
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| Vol #:
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| 1
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| SUP
34
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| Northfield Laboratories Inc BB IND 10719
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| Vol #:
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| 38
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
15501
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| McLind Corporation
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| Vol #:
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| 136
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| LET
15502
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| McLind Corporation
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| Vol #:
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| 136
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| LET
15503
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| McLind Corporation
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| Vol #:
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| 136
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| LET
15504
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| McLind Corporation
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| Vol #:
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| 136
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| LET
15505
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| McLind Corporation
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| Vol #:
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| 136
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| LET
15506
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| McLind Corporation
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| Vol #:
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| 136
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7472
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| R. Claypool
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| Vol #:
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| 319
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| 2000N-0504
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| Egg Safety Action Plan
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| C 376
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| 16 signatures
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| Vol #:
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| 32
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| C 377
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| C. Knowles
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| Vol #:
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| 32
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 1106
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| Bayer Corporation
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| Vol #:
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| 480
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| EXB 1107
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| Bayer Corporation
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| Vol #:
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| 480
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| EXB 1108
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| Bayer Corporation
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| Vol #:
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| 480
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| EXB 1109
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| Bayer Corporation
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| Vol #:
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| 480
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| 2000V-1261
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| FluoroScan Premier mini C-Arm
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| EXP
1
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| Hologic, Inc.
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| Vol #:
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| 1
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 2054
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| J. Freund
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| Vol #:
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| 300
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| CR
2
Attachment
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| Schering-Plough
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| Vol #:
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| 6
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| C 19
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| S. Goldrich
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| Vol #:
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| 2
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| C
42
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| Temple University
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| Vol #:
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| 3
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| 2004D-0465
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| Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
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| C
1
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| Targeted Genetics Corporation (TGC)
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| Vol #:
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| 1
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| 2004D-0493
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| Draft Guidance for Industry on Recommended Approaches to Integration of Genetic Toxicology Study Results
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| C
4
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| Pfizer, Inc.
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| Vol #:
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| 1
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| 2004G-0381
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| Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| SUP
1
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| Federal Express Corporation
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| Vol #:
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| 1
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| C 198
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| A. Klemperer
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| Vol #:
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| 23
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| C
12
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| Hoffman-La Roche, Inc. (Roche)
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| Vol #:
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| 4
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| C 7
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| M. Chrvala
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| Vol #:
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| 5
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| C 8
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| N. Sugiyama
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| Vol #:
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| 5
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| C
9
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| American Institute for Biosocial and Medical research, Inc. (AIBMR)
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| Vol #:
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| 5
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| C 10
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| S. Robinson
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| Vol #:
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| 5
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| C 11
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| L. Hartelius
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| Vol #:
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| 5
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| C
12
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| National Nutritional Foods Assn (NNFA)
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| Vol #:
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| 5
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| C
13
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| American Botanical Council (ABC)
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| Vol #:
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| 5
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| C
14
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| Utah Natural Products Alliance (UNPA)
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| Vol #:
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| 5
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| C 15
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| Dr. Johns
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| Vol #:
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| 5
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| C 16
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| R. Kurtz
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| Vol #:
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| 5
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| C 17
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| J. Semple, MA
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| Vol #:
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| 5
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| C 18
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| E. Pecce
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| Vol #:
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| 5
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| C 19
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| B. Edmond
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| Vol #:
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| 5
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| C
20
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| Hyman, Phelps & McNamara, PC
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| Vol #:
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| 5
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| C 21
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| Rev. R. Beck
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| Vol #:
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| 5
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| C 22
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| 25 signatures
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| Vol #:
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| 5
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| C
23
Attachments
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| American Herbal Products Assn (AHPA)
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| Vol #:
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| 5
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| C 24
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| Form Letters
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| Vol #:
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| 10
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| C 25
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| Form Letters
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| Vol #:
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| 11
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| C 26
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| Form Letters
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| Vol #:
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| 12
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| 2004N-0535
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| Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
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| C
1
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| Novartis Pharmaceuticals Corporation (Novartis)
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| Vol #:
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| 1
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| 2004N-0559
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| Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
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| C
7
Attachment
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| Taylor MicroTechnology, Inc. (TMT)
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| Vol #:
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| 2
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| C 8
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| P and J Green
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| Vol #:
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| 2
| |
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| 2004P-0060
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| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
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| LET
12
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| HFS-800 to Hogan & Hartson, LLP
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| Vol #:
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| 3
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| 2004P-0298
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| Nutrient Content Claims for the Carbohydrate Content of Food
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| LET
2
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| Unilever United States Inc
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| Vol #:
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| 2
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| 2004P-0299
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| Nutrient Content Claims for Carbohydrates
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| LET
2
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| Frito-Lay Inc
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| Vol #:
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| 1
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| 2004P-0522
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| Off label drug use for CYTOTEC
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| SUP
1
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| The Tatia Oden French Memorial Foundation
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| Vol #:
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| 1
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| 2005M-0055
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| P930016/S017, STAR S4 Excimer Laser System with Variable Spot Scanning (VSS) and WaveScan WaveFront System, Approved 12/14/04
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| AAV
1
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| VISX, Inc.
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| Vol #:
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| 1
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| 2005N-0036
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| Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
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| APE
1
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| Novo Nordisk, Inc
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| Vol #:
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| 1
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| APE
2
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| Healthcare Group
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| Vol #:
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| 1
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| APE
3
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| Schwarz BioSciences
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| Vol #:
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| 1
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| APE
1
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| National Council on Ethics in Human Research
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| Vol #:
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| 1
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| EAPE 1
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| sadowski, wayne
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| Vol #:
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| 0
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| 2005P-0060
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| Hydrochlorothiazide Tablets 12.5 mg, is suitable for submission in an ANDA
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| ACK
1
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| HFA-305 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| CP
1
Attachment
1, 2,
3
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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|
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| 2005P-0061
|
| Determine wheather the listed drug has been withdrawn for safety or effeftiveness reason
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| ACK
1
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| HFA-305- to AAC Consulting Group Inc.
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| Vol #:
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| 1
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| CP
1
Attachment
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| Sun Pharmaceutical Industries Ltd.
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| Vol #:
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| 1
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