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| Dockets Entered
On May 24, 2005
Table of Contents
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| Docket #
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| Title
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| 1995N-0294
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| Quality/fill container; common or unusual name regulations
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| 2002D-0467
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| Blood products safety cases known/suspected West Nile Virus
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| 2002P-0520
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| Reclassification of Beta-Tricalcium Phosphate,
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| 2003D-0554
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| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| 2004P-0220
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| determine that the reference listed drug Zithromax (azithromycin) oral capsules,NDAS 50-670 was not withdrawn from sale for reasons related to safety or effectiveness
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| 2004P-0520
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| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
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| 2004P-0523
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| generic fluticasone propionate nasal spray products meet the same high standards of quality as GSK's brand-name product Flonase
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| 2005D-0047
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| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
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| 2005D-0199
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| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Accep
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| 2005D-0200
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| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Accep
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| 2005N-0105
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| Proposal to Debar James T. Kimball; Notice of Opportunity for Hearing
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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| 2005P-0139
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| withdrawal of approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
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| 2005P-0189
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| Nutrient content claims for ALA and DHA omega-3 fatty acids
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| 2005P-0204
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| deny the pre-market approval applications of Mentor Corporation and Inamed Corporation for approval of silicone-gel filled breast implant products
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| 2005P-0205
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| Revise Drug Labeling for Adverse Event of Tendonopathy and Tendon Rupture
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| 2005V-0206
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| Laser Light Show
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| 1995N-0294
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| Quality/fill container; common or unusual name regulations
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| BKG
1
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| BACKGROUND
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| Vol #:
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| 4
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| NPR
1
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| FDA
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| Vol #:
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| 4
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| N
7
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| FDA
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| Vol #:
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| 9
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| 2002D-0467
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| Blood products safety cases known/suspected West Nile Virus
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| BKG
1
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| Background
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| Vol #:
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| 2
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| GDL
3
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| Guidance
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| Vol #:
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| 1
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| NAD
3
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| FDA
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| Vol #:
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| 1
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| 2002P-0520
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| Reclassification of Beta-Tricalcium Phosphate,
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| LET
3
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| HFZ-400 to Bicon, Incorporated
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| Vol #:
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| 2
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| 2003D-0554
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| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| | | | | | | | |
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| C
4
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| Eastern Maine Railway Company et al.
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| Vol #:
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| 1
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| SUP 1
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| Erlinda Enriquez, M.D.
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| Vol #:
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| 1
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| C 32
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| G. Mondrut
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| Vol #:
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| 1
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| C 33
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| Mrs. Jordan
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| Vol #:
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| 1
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| EMC 281
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| J. Stetzel
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| Vol #:
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| 3
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| EMC 282
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| S. Pricer
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| Vol #:
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| 3
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| EMC 283
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| J. Freitag
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| Vol #:
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| 3
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| EMC 284
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| D. Johnson
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| Vol #:
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| 3
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| EMC 285
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| T. Rush
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| Vol #:
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| 3
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| 2004P-0220
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| determine that the reference listed drug Zithromax (azithromycin) oral capsules,NDAS 50-670 was not withdrawn from sale for reasons related to safety or effectiveness
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004P-0520
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| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
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| LET
1
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| HFD-005 to Venable, LLP
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| Vol #:
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| 2
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| 2004P-0523
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| generic fluticasone propionate nasal spray products meet the same high standards of quality as GSK's brand-name product Flonase
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| LET
1
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| HFD-005 to GlaxoSmithKline (GSK)
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| Vol #:
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| 1
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| 2005D-0047
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| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
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| C
3
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| Vical Incorporated
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| Vol #:
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| 1
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| 2005D-0199
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| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Accep
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2005D-0200
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| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Accep
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2005N-0105
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| Proposal to Debar James T. Kimball; Notice of Opportunity for Hearing
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| HER 1
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| James T. Kimball
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| Vol #:
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| 1
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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| C
2
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| Ranbaxy Laboratories, Inc. (Ranbaxy)
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| Vol #:
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| 1
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| EMC 462
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| T. Brown
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| Vol #:
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| 3
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| EMC 463
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| J. Lyons
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| Vol #:
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| 3
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| EMC 464
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| D. Chiccone
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| Vol #:
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| 3
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| EMC 465
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| A. Chadha
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| Vol #:
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| 3
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| EMC 466
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| K. Martellaro
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| Vol #:
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| 3
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| EMC 467
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| Y. Haitsma
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| Vol #:
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| 3
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| EMC 468
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| S. Leifeste
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| Vol #:
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| 3
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| EMC 469
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| J. Fenn
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| Vol #:
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| 3
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| EMC 470
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| L. Cruz
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| Vol #:
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| 3
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| EMC 471
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| M. Maisenhalter
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| Vol #:
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| 3
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| EMC 472
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| C. White
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| Vol #:
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| 3
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| EMC 473
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| K. Tucker
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| Vol #:
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| 3
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| EMC 474
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| T. Chin
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| Vol #:
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| 3
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| EMC 475
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| K. Gallard
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| Vol #:
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| 3
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| EMC 476
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| N. Reid
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| Vol #:
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| 3
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| EMC 477
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| S. Stuckman
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| Vol #:
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| 3
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| EMC 478
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| D. Buitron
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| Vol #:
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| 3
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| EMC 479
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| R. Laureyns
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| Vol #:
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| 3
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| EMC 480
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| K. Hall
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| Vol #:
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| 3
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| EMC 481
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| H. Payne
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| Vol #:
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| 3
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| EMC 482
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| L. Pate
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| Vol #:
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| 3
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| EMC 483
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| T. Faircloth
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| Vol #:
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| 3
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| EMC 484
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| A. Hughes
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| Vol #:
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| 3
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| EMC 485
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| M. Thrantell
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| Vol #:
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| 3
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| EMC 486
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| M. Johnson
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| Vol #:
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| 3
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| 2005P-0189
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| Nutrient content claims for ALA and DHA omega-3 fatty acids
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| ACK
1
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| HFS-830 to Hogan & Hartson LLP
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| Vol #:
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| 2
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| CP
1
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| Martek Biosciences Corporation
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| Vol #:
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| 1
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| LET
1
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| Martek Biosciences Corporation
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| Vol #:
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| 2
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| 2005P-0204
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| deny the pre-market approval applications of Mentor Corporation and Inamed Corporation for approval of silicone-gel filled breast implant products
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| ACK
1
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| HFA-305 to Zuckerman Spaeder LLP
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| Vol #:
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| 1
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| CP
1
Appendix
A
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| Zuckerman Spaeder LLP
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| Vol #:
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| 1
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| 2005P-0205
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| Revise Drug Labeling for Adverse Event of Tendonopathy and Tendon Rupture
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| ACK
1
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| HFA-305 to Office of Illinois Attorney General
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| Vol #:
|
| 1
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| CP
1
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| Office of Illinois Attorney General
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| Vol #:
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| 1
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