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| Dockets Entered
On December 2, 2004
Table of Contents
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| Docket #
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| Title
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| 1991N-0384
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| Nutrient Claims, Definitions of Terms, General Principles
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1996P-0418
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| Reduce the Precense of Salmonella Enteritidis in Shell Eggs
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| 1996P-0500
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| Amend "Healthy" Definition re: Sodium Levels
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| 1996V-0088
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| Variance for Laser Light Show
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| 1997P-0197
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| Require that warning labels about risks of salmonella enteri
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| 1998P-0203
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| Eliminate Forced Molting of Laying Birds
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| 2000N-0504
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| Egg Safety Action Plan
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002D-0018
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| Race and Ethnicity Data in Clinical Trials for FDA
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| 2002P-0413
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| Health Claim: Phosphatidylserine and cognitive dysfunction
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| 2003N-0059
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| Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach
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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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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| 2004D-0443
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| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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| 2004N-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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| 2004N-0267
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| Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications
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| 2004P-0059
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| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
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| 2004P-0386
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| Reject New Drug Application 21-695
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| 2004P-0411
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| Compel Enforcement and Regulation of Amyl Nitrate
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 2004V-0155
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| Valley Forge Composite Technologies Explosive Detection Systems
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| 1991N-0384
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| Nutrient Claims, Definitions of Terms, General Principles
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| SUP 3
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| ConAgra Foods, Inc.
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| Vol #:
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| 13
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT
249
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| Medical Research Institute
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| Vol #:
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| 181
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| RPT
250
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| Ztis Inc (SK Pharma Co. Ltd)
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| Vol #:
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| 182
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| RPT
251
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| American Research Institute of World Traditional Medicine
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| Vol #:
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| 183
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| 1996P-0418
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| Reduce the Precense of Salmonella Enteritidis in Shell Eggs
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| C 842
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| A. Kasper
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| Vol #:
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| 33
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| C 843
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| M. Romero
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| Vol #:
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| 33
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| C 844
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| L. Nissim
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| Vol #:
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| 33
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| C
845
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| Henningsen Food, Inc.
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| Vol #:
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| 33
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| C 846
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| S. Amy
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| Vol #:
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| 33
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| EMC 11447
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| B. Funck
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| Vol #:
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| 296
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| EMC 11448
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| M. Sobhy
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| Vol #:
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| 296
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| EMC 11449
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| T. Davis
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| Vol #:
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| 296
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| EMC 11450
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| L. Devitt
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| Vol #:
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| 296
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| EMC 11451
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| Ricarra j
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| Vol #:
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| 296
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| EMC 11452
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| J. Joh
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| Vol #:
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| 296
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| 2002D-0018
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| Race and Ethnicity Data in Clinical Trials for FDA
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| EMC
3
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| CDISC Submission Data Standards Team
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| Vol #:
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| 2
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| EMC
4
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| CDISC Submission Data Standards Team
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| Vol #:
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| 2
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| 2002P-0413
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| Health Claim: Phosphatidylserine and cognitive dysfunction
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| LET
7
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| HF-22
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| Vol #:
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| 6
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| 2003N-0059
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| Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach
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| C
5
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| International Assn for Pharmaceutical Science and Technology (PDA)
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| Vol #:
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| 1
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| C
6
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| International Assn for Pharmaceutical Science and Technology (PDA)
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| Vol #:
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| 1
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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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| EMC 472
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| P. Cannin
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| Vol #:
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| 9
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| EMC 473
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| A. Richter
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| Vol #:
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| 9
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| EMC 474
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| J. Haffner
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| Vol #:
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| 9
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| EMC 475
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| D. Smith
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| Vol #:
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| 9
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| EMC 476
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| No signature
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| Vol #:
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| 9
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| EMC
2
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| AOPHA Health Committee
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| Vol #:
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| 1
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| EMC
3
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| Indiana Medical Device Manufacturers Council (IMDMC)
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| Vol #:
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| 1
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| 2004D-0443
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| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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| EMC
2
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| Facility automation Management engineering (FAME) Systems
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| Vol #:
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| 1
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| 2004N-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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| EMC 20
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| H. Qutub
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| Vol #:
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| 3
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| EMC 21
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| H. Qutub
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| Vol #:
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| 3
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| 2004N-0267
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| Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications
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| EMC 5
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| H. Qutub
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| Vol #:
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| 1
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| EMC 6
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| H. Qutub
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| Vol #:
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| 1
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| 2004P-0059
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| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
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| LET
11
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| HF-22
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| Vol #:
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| 13
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| 2004P-0386
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| Reject New Drug Application 21-695
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| PDN
1
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| HFD-7 TO Arnold & Porter LLP
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| Vol #:
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| 1
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| 2004P-0411
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| Compel Enforcement and Regulation of Amyl Nitrate
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| EMC
5
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| Committee to Monitor Poppers
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| Vol #:
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| 1
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| EMC
6
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| Committee to Monitor Poppers
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| Vol #:
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| 1
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| EMC 13
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| Soy Information Service
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| Vol #:
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| 5
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| EMC 14
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| The Weston A. Price Foundation
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| Vol #:
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| 5
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| EMC 15
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| Soy Information Service
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| Vol #:
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| 5
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| LET 3
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| The Solae Company
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| Vol #:
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| 5
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| 2004V-0155
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| Valley Forge Composite Technologies Explosive Detection Systems
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| SUP
1
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| Valley Forge Composite Technologies
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| Vol #:
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| 1
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