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| Dockets Entered
On May 11, 2007
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| Docket #
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| Title
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| 1977N-0094L
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| Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
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| 2003M-0560
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| P030039, CoSeal Surgical Sealant
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2004E-0425
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| Patent Extension for Plenaxis (abarelix), U.S. Patent No. 5,843,901
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| 2004P-0055
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| Issue a written opinion stating that Bio-Rad's longstanding practice, previously accepted by the agency, of developing unified, truthful labeling for domestic and international sales of its control pr
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| 2005E-0252
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| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-754), U.S. Patent No. 5,376,634
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| 2006D-0480
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| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
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| 2006E-0023
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 and NDA 21-754), U.S. Patent No. 6,107,458
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| 2006E-0345
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 & NDA 21-754), U.S. Patent No. 6,265,536
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| 2007M-0180
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| P040024/S006 - Perlane Injectable Gel
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| 2007M-0188
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| P990037/S024 - Vascular Solutions D-Star Flowable Hemostat
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| 2007M-0189
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| P060011 - C-flex Model 570C Intraocular Lens (IOL)
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| |
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| 1977N-0094L
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| Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
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| EC 4
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| American Assn for the Study of Liver Diseases
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| Vol #:
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| 1
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| 2003M-0560
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| P030039, CoSeal Surgical Sealant
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| CR 1
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| Baxter Healthcare Corporation
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| Vol #:
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| 1
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| EC 8047
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| Mr. David Keller
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| Vol #:
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| 65
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| EC 8048
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| Mr. Arran Thomson
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| Vol #:
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| 65
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| EC 8049
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| Care2.com
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| Vol #:
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| 65
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| EC 8050
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| Ms. Jandi diazz
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| Vol #:
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| 65
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| EC 8051
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| Miss. Judy Chin
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| Vol #:
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| 65
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| EC 8052
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| Mr. mICHAEL mATHISEN
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| Vol #:
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| 65
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| EC 8053
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| Miss. Muriel Smith
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| Vol #:
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| 65
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| EC 8054
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| Ms. r brailly
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| Vol #:
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| 65
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| EC 8055
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| Mrs. Barbara Greenwood
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| Vol #:
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| 65
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| EC 8056
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| Dr. Joyce Bloom
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| Vol #:
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| 65
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| EC 8057
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| Ms. Lauren Stone
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| Vol #:
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| 65
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| EC 8058
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| Miss. Laura Holmes
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| Vol #:
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| 65
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| EC 8059
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| Cyagra, Inc.
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| Vol #:
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| 65
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| EC 8060
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| Mrs. Chantal Buslot
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| Vol #:
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| 65
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| EC 8061
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| Mr. Jason Kaas
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| Vol #:
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| 65
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| EC 8062
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| Ms. Christine Lofgren
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| Vol #:
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| 65
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| EC 8063
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| Mrs. Kalinke ten Hulzen
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| Vol #:
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| 65
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| EC 8064
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| Ms. Leni Parker
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| Vol #:
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| 65
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| EC 8065
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| National Cattlemen's Beef Association
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| Vol #:
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| 65
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| EC 8066
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| Mrs. Nelly Cortes
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| Vol #:
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| 65
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| EC 8067
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| Mrs. Julie Heath-Kroona
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| Vol #:
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| 65
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| EC 8068
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| Berkshire Veg. Network
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| Vol #:
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| 65
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| EC 8069
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| Ms. Ayesha Shabazz
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| Vol #:
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| 65
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| EC 8070
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| Mr. William Johnson
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| Vol #:
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| 65
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| EC 8071
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| Miss. Jayne McAndrews
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| Vol #:
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| 65
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| EC 8072
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| Federation of Animal Science Societies
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| Vol #:
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| 65
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| EC 8073
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| Federation of Animal Science Societies
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| Vol #:
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| 65
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| EC 8074
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| Mrs. Kelly Dombek
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| Vol #:
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| 65
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| EC 8075
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| Ecumenical Eco-justice Network
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| Vol #:
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| 65
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| EC 8076
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| Ms. Elsa Herrera
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| Vol #:
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| 65
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| EC 8077
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| Mrs. BEVERLEY SHEETS
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| Vol #:
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| 65
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| EC 8078
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| Ms. Christina McGarry
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| Vol #:
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| 65
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| EC 8079
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| Mr. Daniel Lamoureux
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| Vol #:
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| 65
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| EC 8080
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| Miss. Robyn Reichert
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| Vol #:
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| 65
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| EC 8081
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| Mrs. Kimberly O'Brien
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| Vol #:
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| 65
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| EC 8082
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| Mrs. Stacey Fokkema
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| Vol #:
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| 65
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| EC 8083
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| PEOPLE FOR ANIMALS HARYANA <www.pfaharyana.in>
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| Vol #:
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| 65
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| EC 8084
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| Ms. Dominika Kierecka
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| Vol #:
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| 65
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| EC 8085
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| Mr. Randy Oakes
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| Vol #:
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| 65
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| EC 8086
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| AgResearch Ltd.
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| Vol #:
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| 65
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| EC 8087
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| Dr. Alex Minella
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| Vol #:
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| 65
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| EC 8088
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| Ms. Jenni Sademies
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| Vol #:
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| 65
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| EC 8089
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| Ms. P L Lewandowski Powley
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| Vol #:
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| 65
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| EC 8090
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| Heartland Farms
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| Vol #:
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| 65
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| EC 8091
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| Wells' Dairy, Inc.
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| Vol #:
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| 65
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| EC 8092
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| Schreiber
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| Vol #:
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| 65
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| EC 8093
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| Dr. J Schumacher
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| Vol #:
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| 65
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| EC 8094
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| Ms. Monica Taras
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| Vol #:
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| 65
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| EC 8095
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| National Milk Producers Federation
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| Vol #:
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| 65
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| EC 8096
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| Mr. Peter Stein
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| Vol #:
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| 65
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| |
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| EC 8097
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| Mr. Peter Stein
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| Vol #:
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| 65
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| EC 8098
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| Center for Food, Nutrition, and Agriculture Policy
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| Vol #:
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| 65
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| EC 8099
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| Mrs. Loretta Perez
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| Vol #:
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| 65
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| |
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| EC 8100
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| Sargento Foods Inc.
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| Vol #:
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| 65
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| EC 8101
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| Grande Cheese Company
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| Vol #:
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| 65
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| EC 8102
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| Ms. Mary Sims
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| Vol #:
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| 65
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| EC 8103
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| Mr. Jeff Baldwin
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| Vol #:
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| 65
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| EC 8104
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| Mrs. Alice Stephenson
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| Vol #:
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| 65
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| EC 8105
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| NA
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| Vol #:
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| 65
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| EC 8106
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| Miss. KATHLEEN BRAY
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| Vol #:
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| 65
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| EC 8107
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| Mr. Joseph Waresak
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| Vol #:
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| 65
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| EC 8108
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| Mrs. Jennifer Bigelow
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| Vol #:
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| 65
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| |
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| EC 8109
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| Mr. Richard Harter
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| Vol #:
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| 65
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| |
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| EC 8110
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| Nation Dairy Holdings, LP
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| Vol #:
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| 65
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| EC 8111
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| Mrs. Charlene Padula
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| Vol #:
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| 65
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| |
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| EC 8112
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| Mrs. Kim Vaughn
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| Vol #:
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| 65
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| |
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| EC 8113
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| University of California, Davis
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| Vol #:
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| 65
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| EC 8114
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| American Meat Institute
|
| Vol #:
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| 65
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| |
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| EC 8115
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| Mrs. Deanne Sevier
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| Vol #:
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| 65
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| EC 8116
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| Ms. Heather McShea
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| Vol #:
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| 65
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| |
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| EC 8117
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| Ms. Samantha Steffen
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| Vol #:
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| 65
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| |
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| EC 8118
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| Miss. Kimberly Griffith
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| Vol #:
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| 65
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| |
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| EC 8119
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| Miss. STEPHANIE J. BEDOKA
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| Vol #:
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| 65
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| |
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| EC 8120
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| FDA
|
| Vol #:
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| 65
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| |
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| EC 8121
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| Mr. robert collins
|
| Vol #:
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| 65
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| |
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| EC 8122
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| Ms. Emily Lazalde
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| Vol #:
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| 65
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| |
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| EC 8123
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| Ms. Aleta Yarber
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| Vol #:
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| 65
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| |
|
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| EC 8124
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| Mrs. Celia Beadle
|
| Vol #:
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| 65
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| |
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| EC 8125
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| Mr. Nicholas Herndon
|
| Vol #:
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| 65
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| |
|
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| EC 8126
|
| Center for Global Food Issues
|
| Vol #:
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| 65
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| |
|
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| EC 8127
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| Ms. Jamie Watson
|
| Vol #:
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| 65
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| |
|
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| EC 8128
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| Mrs. Bonnie Mekelburg
|
| Vol #:
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| 65
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| |
|
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| EC 8129
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| Ms. phillip garcia
|
| Vol #:
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| 65
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| |
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| EC 8130
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| Dr. Allison Shah
|
| Vol #:
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| 65
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| |
|
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| EC 8131
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| Mrs. Autumn Zimmerman
|
| Vol #:
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| 65
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| |
|
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| EC 8132
|
| Ms. rachel Dowling
|
| Vol #:
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| 65
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| |
|
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| EC 8133
|
| Miss. Monique Greene
|
| Vol #:
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| 65
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| |
|
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| EC 8134
|
| Publix Super Markets, Inc
|
| Vol #:
|
| 65
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| |
|
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| EC 8135
|
| Mrs. juana felix
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| Vol #:
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| 65
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|
| | | | | | | | |
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| |
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| EC 8136
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| Ms. Amy Lett
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| Vol #:
|
| 65
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| |
|
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| EC 8137
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| Union of Concerned Scientists
|
| Vol #:
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| 68
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| |
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| EC 8138
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| Miss. Stephanie Roelling
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| Vol #:
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| 68
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| |
|
|
| EC 8139
|
| Mr. Jeremy Nichols
|
| Vol #:
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| 68
|
| |
|
|
| 2004E-0425
|
| Patent Extension for Plenaxis (abarelix), U.S. Patent No. 5,843,901
|
| |
|
|
| LET 5
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0055
|
| Issue a written opinion stating that Bio-Rad's longstanding practice, previously accepted by the agency, of developing unified, truthful labeling for domestic and international sales of its control pr
|
|
|
|
|
|
| | |
|
|
| PDN 1
|
| FDA/CDRH to Bio-Rad Laboratories
|
| Vol #:
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| 2
|
| |
|
|
| 2005E-0252
|
| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-754), U.S. Patent No. 5,376,634
|
| |
|
|
| LET 5
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0480
|
| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
|
| |
|
|
| EC 135
|
| Ms. Carola Dunham
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| Vol #:
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| 6
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| |
|
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| EC 136
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| Mrs. Cheryl Kemptner
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| Vol #:
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| 6
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| |
|
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| EC 137
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| Ms. Kay Bailey
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| Vol #:
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| 5
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| |
|
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| EC 138
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| Mr. William McCall
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| Vol #:
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| 6
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| |
|
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| EC 139
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| Mr. Thomas Boynton
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| Vol #:
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| 6
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| |
|
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| EC 140
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| Mr. John Mast
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| Vol #:
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| 6
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| |
|
|
| EC 141
|
| Ms. Charlotte Branca
|
| Vol #:
|
| 6
|
| |
|
|
| 2006E-0023
|
| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 and NDA 21-754), U.S. Patent No. 6,107,458
|
| |
|
|
| LET 9
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 2
|
| |
|
|
| 2006E-0345
|
| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 & NDA 21-754), U.S. Patent No. 6,265,536
|
| |
|
|
| LET 7
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2007M-0180
|
| P040024/S006 - Perlane Injectable Gel
|
| |
|
|
| AAV 1
|
| Medicis Aesthetics Holdings, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007M-0188
|
| P990037/S024 - Vascular Solutions D-Star Flowable Hemostat
|
| |
|
|
| AAV 1
|
| Vascular Solutions, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007M-0189
|
| P060011 - C-flex Model 570C Intraocular Lens (IOL)
|
| |
|
|
| AAV 1
|
| Rayner Surgical, Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2007N-0121
|
| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
|
| |
|
|
| EAPE 163
|
| Bozic, Carmen
|
| Vol #:
|
| 1
|
|
| | | | | | | |
|
| |
|
| EAPE 164
|
| Ryan, Sheila
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 165
|
| Newcomer, Carrie
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 166
|
| Toscano, Amy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 167
|
| Safarik, Michelle
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 168
|
| Sammeta, Vijay
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 169
|
| Rowlands, Jehan
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 170
|
| Kovich, Douglas
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 171
|
| Frank, Lesley
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 172
|
| McKelvie, Katlin
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 173
|
| Glifort, Gail
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 174
|
| Frank, Lesley
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 175
|
| Davis, Thomas
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 176
|
| Brennan, RPh, Colleen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 177
|
| Ziegler, PharmD, MBA, Bryan
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 178
|
| Fassler, David
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 179
|
| Bough, Marcie
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 180
|
| Michaels, Alex
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 181
|
| Matzke, Gary
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 182
|
| Watkins, Carol
|
| Vol #:
|
| 1
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| |
|
|
| EC 2
|
| Felpausch Pharmacies
|
| Vol #:
|
| 6
|
|
|
