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| Dockets Entered
On August 1, 2005
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998C-0431
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| Synthetic Iron Oxide
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000N-0504
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| Egg Safety Action Plan
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| 2000P-1671
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| Patient Medicine Guides (MedGuides)/Cox-II & NSAID
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| 2001C-0486
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| Tomato lycopene extract to color foods generally
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| 2001N-0275
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| Performance standard for Diagnostic X-Ray Systems & Major Co
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| 2002N-0510
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| Proposal to Debar Thomas M. Rodgers, Jr.
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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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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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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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-0463
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| Food Labeling: Prominence of Calories
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| 2004N-0479
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| Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability
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| 2004N-0480
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| The Minor Use & Minor Species (MUMS) Animal Health Act
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| 2004P-0223
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| Whole Grain Descriptive Claims
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| 2004P-0405
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| ANDA Suitability for Tramadol Hydrochloride Oral Solution, 50 mg per 5mL
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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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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| 2005D-0174
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| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| 2005D-0261
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| Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 2005P-0034
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| Remove the COX-2 Inhibitors Celecoxib (Celebrex) and Valdecoxib (Bextra) from the Market
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| 2005P-0305
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| Remove Dietary Supplements that Contain the Drug Pyridoxamine
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16423
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| Cell Tech International Incorporated
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| Vol #:
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| 146
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| LET
16424
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| NBTY Inc.
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| Vol #:
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| 146
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| LET
16425
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| NBTY Inc.
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| Vol #:
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| 146
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| LET
16426
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| WTSMED, Inc.
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| Vol #:
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| 146
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| 2001C-0486
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| Tomato lycopene extract to color foods generally
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| EREG
1
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| Ingredient Systems
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| Vol #:
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| 1
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| 2001N-0275
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| Performance standard for Diagnostic X-Ray Systems & Major Co
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| REF
2
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| HF-26
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| Vol #:
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| 5
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C
2089
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| American Society for Reproductive Medicine
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| Vol #:
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| 300
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| EMC 14484
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| Number Not Used
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| Vol #:
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| 342
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| EMC 14485
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| R. Mack
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| Vol #:
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| 342
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| REF 4
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| OMB review for Publication Date October 10, 2003
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| Vol #:
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| 37
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| 2002N-0510
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| Proposal to Debar Thomas M. Rodgers, Jr.
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| LET
2
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| HFM-600 to Thomas M. Rodgers, Jr.
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| Vol #:
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| 1
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 494
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| Mission Possible International
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| Vol #:
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| 8
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| EMC 495
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| Mission Possible International
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| Vol #:
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| 8
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| EMC 496
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| Mission Possible International
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| Vol #:
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| 8
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| EMC 497
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| Mission Possible International
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| Vol #:
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| 8
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| EMC 498
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| Mission Possible International
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| Vol #:
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| 8
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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 831
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| C. Montgomery
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| Vol #:
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| 11
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| EMC 832
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| K. Vanhavere
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| Vol #:
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| 11
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| EMC 833
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| R. Erena, MD
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| Vol #:
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| 11
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| EMC 834
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| M. Morton
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| Vol #:
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| 11
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| EMC 835
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| F. Schneider
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| Vol #:
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| 11
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| EMC 836
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| J. Tibbetts
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| Vol #:
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| 11
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| EMC 837
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| B. Dittmar
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| Vol #:
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| 11
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| EMC 838
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| F. McMahan
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| Vol #:
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| 11
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| EMC 839
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| W. Parker, RN
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| Vol #:
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| 11
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| EMC 840
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| S. Levine
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| Vol #:
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| 11
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| EMC 841
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| J. Lopez
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| Vol #:
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| 11
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| EMC 842
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| J. Johnson
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| Vol #:
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| 11
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| EMC 843
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| W and J Gaspord
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| Vol #:
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| 11
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| EMC 844
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| C. Stevens
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| Vol #:
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| 11
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| EMC 882
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| K. Smith
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| Vol #:
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| 11
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| EMC 883
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| G. Neal
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| Vol #:
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| 11
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| EMC 884
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| G. Neal
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| Vol #:
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| 11
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| EMC 885
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| S. D'Angelo
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| Vol #:
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| 11
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| EMC 886
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| S. Cooper
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| Vol #:
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| 11
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| EMC 887
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| M. Yunker
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| Vol #:
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| 11
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| EMC 888
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| A. Ostling
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| Vol #:
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| 11
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| EMC 889
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| M. Olvera,MPH,RD
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| Vol #:
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| 11
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| EMC 890
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| J. Peeters
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| Vol #:
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| 11
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| EMC 891
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| C. Behun
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| Vol #:
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| 11
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| EMC 892
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| J. Vanderbush
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| Vol #:
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| 11
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| EMC 893
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| A. Blowers
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| Vol #:
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| 11
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| EMC 894
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| J. Massaro
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| Vol #:
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| 11
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| EMC 895
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| L. Farr
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| Vol #:
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| 11
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| EC 7
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| Mrs. Diane Schmucker
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| Vol #:
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| 1
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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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| EC
2
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| America's Blood Centers
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| Vol #:
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| 1
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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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| EMC 1165
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| S. McCulloch
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| Vol #:
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| 29
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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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| C
63
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| American Association for Retired Persons (AARP)
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| Vol #:
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| 5
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| C
64
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| Chesterbrook Academy
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| Vol #:
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| 5
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| C
65
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| DeWitt Clinton High School
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| Vol #:
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| 5
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| C 66
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| Ms. S. Belkin
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| Vol #:
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| 5
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| C
67
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| The Association for Dressings & Sauces
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| Vol #:
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| 5
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| EMC
784
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| Nestle USA, Inc.
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| Vol #:
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| 4
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| EMC 785
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| Harvard Medical School
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| Vol #:
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| 4
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| EMC 786
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| UNSIGNED
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| Vol #:
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| 4
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| EMC 787
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| D. Mastromano
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| Vol #:
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| 4
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| EMC 788
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| K. Kopfman
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| Vol #:
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| 4
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| EMC 789
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| J. Kotz
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| Vol #:
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| 4
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| |
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| C
52
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| The Association for Dressings and Sauces
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| Vol #:
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| 4
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| 2004N-0479
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| Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability
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| EMC 2
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| H. Wegener
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| Vol #:
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| 1
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| EMC 3
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| B. Sachau
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| Vol #:
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| 1
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| 2004N-0480
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| The Minor Use & Minor Species (MUMS) Animal Health Act
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| EMC
3
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| MUMS Meeting Notes
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| Vol #:
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| 1
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| EMC
4
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| American Pet Products Manufacturers Association (APPMA)
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| Vol #:
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| 1
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| 2004P-0223
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| Whole Grain Descriptive Claims
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| C
25
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| Campbell Soup Company (Campbell's)
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| Vol #:
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| 5
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|
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| 2004P-0405
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| ANDA Suitability for Tramadol Hydrochloride Oral Solution, 50 mg per 5mL
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| PDN
1
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| HFD-600 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
|
|
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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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| C 3
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| A. Durbin, MD
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| Vol #:
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| 1
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| EMC
4
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| Academy of Managed Care Pharmacy (AMCP)
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| Vol #:
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| 2
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| EMC
5
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| First DataBank, Inc. (First DataBank)
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| Vol #:
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| 2
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| EMC
6
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| First DataBank, Inc. (First DataBank)
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| Vol #:
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| 2
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| 2005D-0174
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| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
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| C
2
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| Methodist Hospital
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| Vol #:
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| 1
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|
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| EC
2
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| Pfizer Inc.
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| Vol #:
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| 1
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|
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| 2005D-0261
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| Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
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| EC
1
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| BloodSource
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| Vol #:
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| 1
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|
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| EC
8
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| Mrs. Carolyn Pehlke
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| Vol #:
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| 1
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| EC
9
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| Southern Illinois U. Edws Schl of Nursing
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| Vol #:
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| 1
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|
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| EC
10
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| UCSD Medical Center
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| Vol #:
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| 1
|
|
|
|
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| 2005P-0034
|
| Remove the COX-2 Inhibitors Celecoxib (Celebrex) and Valdecoxib (Bextra) from the Market
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|
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| PAV
1
|
| HFD-001 to Public Citizen Health Research Group
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| Vol #:
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| 1
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