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| Dockets Entered
On May 2, 2005
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 1980P-0100
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| LIGHT SHOW PROJECTOR "RAINBOW"
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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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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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| 2000N-1396
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| Bioengineered Foods Consumed By Humans or Animals
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2000P-1322
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| Food Labeling and Allergen Contamination Control
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| 2001N-0548
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| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2002N-0204
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| Bar Code Label Requirements for human drug products
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003D-0497
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| Guidance for Industry on Pharmacogenomic Data Submissions
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003P-0159
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| Venlafaxine Hydrochloride Extended-Release Tablets
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| 2004D-0188
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| Guidance for Industry on Development and Use of Risk Minimization Action Plans
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| 2004D-0510
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| Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
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| 2004N-0330
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| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
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| 2004N-0366
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| Working with Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies
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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-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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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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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 2005D-0004
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| Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations
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| 2005D-0021
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| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
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| 2005D-0022
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| International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals
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| 2005D-0030
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| Guidance for Industry on Clinical Lactation Studies Study Design, Data Analysis, and Recommendations for Labeling
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| 2005D-0103
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| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
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| 2005D-0155
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| Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
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| 2005M-0158
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| Bayer Healthcare, LLC; Premarket approval for ADVIA Centaur HBc IgM ReadyPack Reagents and ADVIA Centaur HBc IgM Quality Control Materials, P030040
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| 2005M-0159
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| Ventana Medical Systems, Inc.; Premarket Approval of Ventana Medical Systems' Pathway Anti-c-KIT (9.7) Primary Antibody, P020055
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| | | | | | | | |
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| 2005M-0160
|
| BioGenex Laboratories, Inc., Premarket Approval of InSite Her-2/neu kit, P040030
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 2005N-0065
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| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
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| 2005N-0077
|
| Color Additive Certification; Increase in Fees for Certification Services
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| 2005N-0097
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| 2005P-0094
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| Remove the drug Iressa (gefitnib; AstraZeneca) from the market immediately
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| 2005P-0166
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| to prevent the unlawful misbanding of prescription distance glasses and contact lenses
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|
| 1980N-0208
|
| Biological Products; Bacterial Vaccines and Toxiods
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|
|
| EC 44
|
| Former Military - Army
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| Vol #:
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| 140
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|
|
| EMC 216
|
| No signature
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| Vol #:
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| 156
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| EMC 217
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| No signature
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| Vol #:
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| 156
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| EMC 218
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| No signature
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| Vol #:
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| 156
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| EMC 219
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| No signature
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| Vol #:
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| 156
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| EMC 220
|
| R. Fields, Sr.
|
| Vol #:
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| 156
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| EMC 221
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| R. Fields, Sr.
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| Vol #:
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| 156
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|
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| EMC 222
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| J. Stone
|
| Vol #:
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| 156
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| EMC 223
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| J. Stone
|
| Vol #:
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| 156
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|
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| 1980P-0100
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| LIGHT SHOW PROJECTOR "RAINBOW"
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|
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| SUP
1
|
| LFI International
|
| Vol #:
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| 2
|
|
|
| 1995N-0304
|
| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
|
|
| EMC 1280
|
| Mission Possible Intl
|
| Vol #:
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| 399
|
|
|
| EMC 1281
|
| Mission Possible Intl
|
| Vol #:
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| 399
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|
|
| EMC 1282
|
| Mission Possible Intl
|
| Vol #:
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| 399
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|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
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|
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| LET
15990
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| Natures Benefit, Inc.
|
| Vol #:
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| 141
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|
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| LET
15991
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| Natures Benefit, Inc.
|
| Vol #:
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| 141
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|
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| LET
15992
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| Natures Benefit, Inc.
|
| Vol #:
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| 141
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|
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| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
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|
|
| C 7476
|
| J. Williams
|
| Vol #:
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| 319
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|
|
| C 7477
|
| J. Williams
|
| Vol #:
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| 319
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|
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| C 7478
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| J. Capozzelli
|
| Vol #:
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| 319
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|
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| EMC 4302
|
| C. Goldstein
|
| Vol #:
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| 320
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|
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| EMC 4303
|
| G. Falcone
|
| Vol #:
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| 320
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|
| | | | | | | | |
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| EMC 4304
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| Jessica A.
|
| Vol #:
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| 320
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|
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| EMC 4305
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| D. Bolbol
|
| Vol #:
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| 320
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|
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| EMC 4306
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| Mr and Mrs V and J Caracci
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| Vol #:
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| 320
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|
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| EMC 4307
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| L. Friedberg
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| Vol #:
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| 320
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|
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| EMC 4308
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| B. Rickus
|
| Vol #:
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| 320
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|
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| EMC 4309
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| J. Kahl
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| Vol #:
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| 320
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|
|
| EMC 4310
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| T. Schroeder
|
| Vol #:
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| 320
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|
|
| EMC 4311
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| D. Cleven
|
| Vol #:
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| 320
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|
|
| EMC 4312
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| T. Knight
|
| Vol #:
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| 320
|
|
|
| EMC 4313
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| E. Maupin
|
| Vol #:
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| 320
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|
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| EMC 4314
|
| N. Mroueh
|
| Vol #:
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| 320
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|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
| C 18227
|
| C. Wrlin
|
| Vol #:
|
| 516
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
| EMC 599
|
| K. Sullivan
|
| Vol #:
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| 24
|
|
|
| EMC 600
|
| C. Soppet
|
| Vol #:
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| 24
|
|
|
| 2000D-1598
|
| Voluntary Labeling for Bioengineered Foods
|
|
|
| EMC 12023
|
| Vinnie
|
| Vol #:
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| 574
|
|
|
| 2000N-1396
|
| Bioengineered Foods Consumed By Humans or Animals
|
|
|
| EMC 11577
|
| Vinne
|
| Vol #:
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| 349
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
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|
|
| SF
12
|
| GCF-1
|
| Vol #:
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| 403
|
|
|
| 2000P-1322
|
| Food Labeling and Allergen Contamination Control
|
|
|
| EMC 541
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| C. Shelleman
|
| Vol #:
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| 30
|
|
|
| EMC 542
|
| C and M Fowler
|
| Vol #:
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| 30
|
|
|
| 2001N-0548
|
| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
|
|
|
| EMC 12
|
| no signature
|
| Vol #:
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| 1
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
| EMC 14392
|
| M. O'Brien
|
| Vol #:
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| 342
|
|
|
| EMC 14393
|
| M. Shorts
|
| Vol #:
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| 342
|
|
|
| EMC 14394
|
| C. Smith
|
| Vol #:
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| 342
|
|
|
| EMC 14395
|
| S. Weiner
|
| Vol #:
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| 342
|
|
| | | | | | | | |
|
|
| EC 346
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| Mr. Richard Yi
|
| Vol #:
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| 8
|
|
|
| EC 347
|
| Ms. Patty Aguilera
|
| Vol #:
|
| 8
|
|
|
| EC 348
|
| n/a
|
| Vol #:
|
| 8
|
|
|
| EC 349
|
| Mr. Al Fogleman
|
| Vol #:
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| 8
|
|
|
| EC 350
|
| Ms. Debra Sall
|
| Vol #:
|
| 8
|
|
|
| EC 351
|
| Mr. Sandy Turley
|
| Vol #:
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| 8
|
|
|
| EC 352
|
| Ms. June Golem
|
| Vol #:
|
| 8
|
|
|
| EC 353
|
| Mr. Keith Farthing
|
| Vol #:
|
| 8
|
|
|
| EC 354
|
| Mrs. Cynthia Afferica
|
| Vol #:
|
| 8
|
|
|
| EC 355
|
| Mr. Paul Troutman
|
| Vol #:
|
| 8
|
|
|
| EC 356
|
| Mrs. Karen Stilson
|
| Vol #:
|
| 8
|
|
|
| EC 357
|
| Mr. Ronald Keel
|
| Vol #:
|
| 8
|
|
|
| EC 358
|
| Mr. James Carole
|
| Vol #:
|
| 8
|
|
|
| EC 359
|
| Mr. Richard Manasek
|
| Vol #:
|
| 8
|
|
|
| EC 360
|
| Downingtown Borough Councilman
|
| Vol #:
|
| 8
|
|
|
| EC 361
|
| Mr. Robert Unger
|
| Vol #:
|
| 8
|
|
|
| 2005D-0004
|
| Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations
|
|
|
| EC
2
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
|
|
| EC
3
|
| Eli Lilly and Company
|
| Vol #:
|
| 1
|
|
|
| EC
4
|
| Hoffmann-La Roche, Inc.
|
| Vol #:
|
| 1
|
|
|
| EC
5
|
| CANTOX Health Sciences International
|
| Vol #:
|
| 1
|
|
|
| 2005D-0021
|
| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
|
|
|
| C
4
|
| Jerussi Consulting, Inc.
|
| Vol #:
|
| 1
|
|
|
| EC
2
|
| Berlex/Schering AG
|
| Vol #:
|
| 1
|
|
|
| EC
3
|
| Novartis Pharmaceuticals Corporation
|
| Vol #:
|
| 1
|
|
|
| EC
4
|
| Bayer Healthcare, Bioogical Products Division
|
| Vol #:
|
| 1
|
|
|
| EC
5
|
| Genentech
|
| Vol #:
|
| 1
|
|
|
| 2005D-0022
|
| International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals
|
|
|
| EC
2
|
| ILSI Health and Environmental Sciences Institute
|
| Vol #:
|
| 1
|
|
|
| 2005D-0030
|
| Guidance for Industry on Clinical Lactation Studies Study Design, Data Analysis, and Recommendations for Labeling
|
|
|
| EC
1
|
| Pfizer
|
| Vol #:
|
| 1
|
|
|
| EC
2
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
|
|
| EC
3
|
| Public Citizen's Health Research Group
|
| Vol #:
|
| 1
|
|
|
| 2005D-0103
|
| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
|
|
| | | | | | | | |
|
|
| C 2
|
| J. Heubi, M.D.
|
| Vol #:
|
| 1
|
|
|
| 2005D-0155
|
| Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2005M-0158
|
| Bayer Healthcare, LLC; Premarket approval for ADVIA Centaur HBc IgM ReadyPack Reagents and ADVIA Centaur HBc IgM Quality Control Materials, P030040
|
|
|
| AAV
1
|
| Bayer Healthcare, LLC
|
| Vol #:
|
| 1
|
|
|
| 2005M-0159
|
| Ventana Medical Systems, Inc.; Premarket Approval of Ventana Medical Systems' Pathway Anti-c-KIT (9.7) Primary Antibody, P020055
|
|
|
| AAV
1
|
| Ventana Medical Systems, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2005M-0160
|
| BioGenex Laboratories, Inc., Premarket Approval of InSite Her-2/neu kit, P040030
|
|
|
| AAV
1
|
| BioGenex Laboratories, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2005N-0038
|
| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
|
|
|
| EC
22
|
| Dana Farber/Partners Cancer Care
|
| Vol #:
|
| 3
|
|
|
| EC
23
|
| MedImmune Inc.
|
| Vol #:
|
| 3
|
|
|
| EC
24
|
| Univ. of Mississippi Medical Center
|
| Vol #:
|
| 3
|
|
|
| EC 25
|
| Dr. Jim Monolakis
|
| Vol #:
|
| 3
|
|
|
| EC
26
|
| University of Michigan
|
| Vol #:
|
| 3
|
|
|
| EC
27
|
| Baylor College of Medicine
|
| Vol #:
|
| 3
|
|
|
| EC
28
|
| Consortium of Independent Review Boards
|
| Vol #:
|
| 3
|
|
|
| EC
29
|
| AdvaMed
|
| Vol #:
|
| 3
|
|
|
| EC
30
|
| Stanford University
|
| Vol #:
|
| 3
|
|
|
| EC
31
|
| U.T. M.D. Anderson Cancer Center
|
| Vol #:
|
| 3
|
|
|
| EC
32
|
| Council on Governmental Relations
|
| Vol #:
|
| 3
|
|
|
| EC
33
|
| SUNY Human Subjects Forum
|
| Vol #:
|
| 3
|
|
|
| EC
34
|
| Pharm Res
|
| Vol #:
|
| 3
|
|
|
| EC
35
|
| Chesapeake Research Review, Inc.
|
| Vol #:
|
| 3
|
|
|
| EC
36
|
| Quorum Review, Inc.
|
| Vol #:
|
| 3
|
|
|
| EC
37
|
| Pfizer Inc
|
| Vol #:
|
| 3
|
|
|
| EC
38
|
| Pfizer Inc
|
| Vol #:
|
| 3
|
|
|
| 2005N-0065
|
| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
|
|
|
| EC
2
|
| National Fisheries Institute
|
| Vol #:
|
| 1
|
|
|
| 2005N-0077
|
| Color Additive Certification; Increase in Fees for Certification Services
|
|
|
| ACK
1
|
| HFA-305 to the International Association of Color Manufacturers
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| ACK
2
|
| HFA-305 to the International Association Color Manufacturers
|
| Vol #:
|
| 1
|
|
|
| C
1
|
| International Assn of Color Manufacturers
|
| Vol #:
|
| 1
|
|
|
| CP
1
|
| International Association Color Manufacturers
|
| Vol #:
|
| 1
|
|
|
| PSA
1
|
| International Association of Color Manufacturers
|
| Vol #:
|
| 1
|
|
|
| 2005N-0097
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
| EC
1
|
| ABC Research Corporation
|
| Vol #:
|
| 1
|
|
|
| 2005P-0094
|
| Remove the drug Iressa (gefitnib; AstraZeneca) from the market immediately
|
|
|
| SUP
1
|
| Public Citizen's Health Research Group (Public Citizen)
|
| Vol #:
|
| 1
|
|
|
| 2005P-0166
|
| to prevent the unlawful misbanding of prescription distance glasses and contact lenses
|
|
|
| ACK
1
|
| HFA-305 to International Myopia Prevention Association
|
| Vol #:
|
| 1
|
|
|
| CP
1
|
| International Myopia Prevention Association
|
| Vol #:
|
| 1
|
|