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| Dockets Entered
On April 23, 2007
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| Docket #
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| Title
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| |
|
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
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| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
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| |
|
|
| 2001E-0420
|
| Patent Term Extension Application for Lotronex No. 5,360,800
|
| |
|
|
| 2002E-0100
|
| Patent Application for Dutrasteride
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| |
|
|
| 2003E-0407
|
| Patent Term Restoration Application for Cypher, U.S. Patent No. 5,563,146
|
| |
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
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| |
|
|
| 2004E-0307
|
| Patent Extension for ALIMTA (pemetrexed), U.S. Patent No. 5,344,932
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| |
|
|
| 2004E-0394
|
| Patent Extension for ALOXI (palonosetron hydrochloride) injection, U.S. Patent No. 5,202,333
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| |
|
|
| 2004E-0445
|
| Patent Extension for HUMIRA (adalimumab), U.S. Patent No. 6,090,382
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| |
|
|
| 2005E-0258
|
| Patent Term Extension Application for OMACOR, U.S. Patent No. 5, 656,667
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| |
|
|
| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| |
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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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| |
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| 2006E-0003
|
| Patent Extension Application for BiDIL (combination of hydralazine hydrochloride and isosorbide dinitrate), U.S. Patent No. 4,868,179
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| |
|
|
| 2006E-0026
|
| Patent Extension Application for Luveris (recombinant human luteinizing hormone), U.S. Patent No. 5,639,639
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| |
|
|
| 2006N-0525
|
| Supplements and Other Changes to an Approved Application
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| |
|
|
| 2007N-0015
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Adoption of the FDA Food Code by Local, State, and Tribal Governments
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| |
|
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| 2007N-0114
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| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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| |
|
|
| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| |
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|
| 2007P-0159
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| Take prompt enforecment actions due to the clearly defined public health risk of Toxic Anterior Segment Syndrome (TASS) and secure the removal of illegally marketed unapproved ophthalmic Balanced Salt
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| |
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| 1990S-0308
|
| Generic Drug Speeches & Policy and Procedure Guides
|
| |
|
|
| RPT 776
|
| Statistical Report - Month of March 2007
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| Vol #:
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| 56
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|
| |
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
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| |
|
|
| EMC 497
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| J. Gagliardo
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| Vol #:
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| 8
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| |
|
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| EMC 498
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| K. Gilleran
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| Vol #:
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| 1
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| |
|
|
| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| |
|
|
| EMC 678
|
| B. Delory
|
| Vol #:
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| 24
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| |
|
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| EMC 679
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| S. Williamson
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| Vol #:
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| 24
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| |
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| EMC 680
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| C. Hyatt
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| Vol #:
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| 24
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| |
|
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| EMC 681
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| K. Orndorff
|
| Vol #:
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| 24
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| |
|
|
| EMC 682
|
| P. Carey
|
| Vol #:
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| 24
|
|
| |
|
| 2001E-0420
|
| Patent Term Extension Application for Lotronex No. 5,360,800
|
| |
|
|
| CEP 1
|
| U.S. Patent and Trademark Office to Glaxo Wellcome Inc.
|
| Vol #:
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| 1
|
|
| | | | | | | | |
|
| |
|
| 2002E-0100
|
| Patent Application for Dutrasteride
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| |
|
|
| CEP 1
|
| U.S. Patent and Trademark Office to GlaxoSmithKline
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0407
|
| Patent Term Restoration Application for Cypher, U.S. Patent No. 5,563,146
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| |
|
|
| CEP 1
|
| U.S. Patent and Trademark Office to Wyeth
|
| Vol #:
|
| 1
|
|
| |
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
| |
|
|
| C 726
|
| F. Crammer
|
| Vol #:
|
| 56
|
| |
|
|
| C 727
|
| G. Chityat
|
| Vol #:
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| 56
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| |
|
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| C 728
|
| P. Laszlo
|
| Vol #:
|
| 56
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| |
|
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| C 729
|
| N. Coursey
|
| Vol #:
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| 56
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| |
|
|
| C 730
|
| M. Nicholls
|
| Vol #:
|
| 56
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| |
|
|
| C 731
|
| W. Melssen
|
| Vol #:
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| 56
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| |
|
|
| C 732
|
| M. Walton
|
| Vol #:
|
| 56
|
| |
|
|
| C 733
|
| M. Fedran
|
| Vol #:
|
| 56
|
| |
|
|
| EC 5715
|
| Ms. Amy Holt
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5716
|
| Ms. carol abramsky
|
| Vol #:
|
| 60
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| |
|
|
| EC 5717
|
| Miss. Cari Silvestri
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5718
|
| Mrs. Nancy Van Iderstine
|
| Vol #:
|
| 60
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| |
|
|
| EC 5719
|
| Ms. Cathy Miller
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5720
|
| Ms. jody newman
|
| Vol #:
|
| 60
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| |
|
|
| EC 5721
|
| Mr. Kinnley Ben
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| Vol #:
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| 60
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| |
|
|
| EC 5722
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| Mr. Jared Brenner
|
| Vol #:
|
| 60
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| |
|
|
| EC 5723
|
| Private Citizen
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5724
|
| Dr. lisa siconolfi
|
| Vol #:
|
| 60
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| |
|
|
| EC 5725
|
| Ms. Crystal Lake
|
| Vol #:
|
| 60
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| |
|
|
| EC 5726
|
| Ms. Suzann Gilmore
|
| Vol #:
|
| 60
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| |
|
|
| EC 5727
|
| Mrs. Lisa Pisano
|
| Vol #:
|
| 60
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| |
|
|
| EC 5728
|
| Mrs. Alicia Caraballo
|
| Vol #:
|
| 60
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| |
|
|
| EC 5729
|
| Miss. Ashley Alvarez
|
| Vol #:
|
| 60
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| |
|
|
| EC 5730
|
| Ms. Chandra Sherin
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5731
|
| Ms. Cheryl Bagley
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5732
|
| Mrs. Emily Carr
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5733
|
| Mrs. SANDRA SCHMIDT
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5734
|
| Mrs. Judy Boyko
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5735
|
| Miss. Lia Laurino
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5736
|
| Miss. Jennifer Nitz
|
| Vol #:
|
| 60
|
|
| | | | | | | |
|
| |
|
| EC 5737
|
| Colon
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5738
|
| Ms. Sylvia Jones
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5739
|
| Ms. Lydia Ryan
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5740
|
| Ms. Reba Stone
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5741
|
| Mrs. Nancy Beavers
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5742
|
| Ms. Marguerite Krull
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5743
|
| Mr. John Armstrong
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5744
|
| Mr. Raymond Medina
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5745
|
| Ms. Lisa Marshall
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5746
|
| Individual
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5747
|
| Ms. Ruth Strother
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5748
|
| na
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5749
|
| Miss. Elizabeth Agostinho
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5750
|
| Mann Family
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5751
|
| Ms. Leslie Just
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5752
|
| Mrs. Tricia Hamilton
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5753
|
| Ms. Donna Sharee
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5754
|
| Dr. Mitch Kennedy
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5755
|
| Ms. Helen Winmill
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5756
|
| Ms. Mary Savoia
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5757
|
| Ms. Deborah Thelen
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5758
|
| na
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5759
|
| Ms. Diane Hutchins
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5760
|
| Mrs. Lizbeth Carlson
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5761
|
| Ms. janet nicosia
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5762
|
| Ms. leslie torres
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5763
|
| Mrs. jane jackson
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5764
|
| Texas Organic Farmers and Gardners Association
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5765
|
| As an Individual
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5766
|
| Mrs. Lillie Greathouse
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5767
|
| Ms. Tanya Sotomayor
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5768
|
| Mrs. Lee Ann Reinfeldt
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5769
|
| Miss. barb sachau
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5770
|
| Mr. Scott Watanabe
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5771
|
| Mrs. Sherry Frey-Brown
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5772
|
| Mrs. Jill Macink
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5773
|
| Ms. Rachel Foxman
|
| Vol #:
|
| 60
|
|
| | | | | | | |
|
| |
|
| EC 5774
|
| Mrs. Kate Harper
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5775
|
| Dr. Gloria Dodd DVM
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5776
|
| Dr. Jennie Baratta
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5777
|
| Mrs. Amy Young
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5778
|
| Ms. Cheryl Morris
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5779
|
| Mrs. Linda Rockhold
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5780
|
| Mrs. Karen Fedorov
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5781
|
| Ms. kathy mesch
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5782
|
| Mrs. Judith Doyle
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5783
|
| Ms. Sandra James
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5784
|
| Ms. Tonya Abbott
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5785
|
| Mrs. Barb Hamilton
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5786
|
| Ms. Rio Magden
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5787
|
| Miss. Tucker Thomas
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5788
|
| Ms. Catherine Godlewski
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5789
|
| Mr. James Celico
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5790
|
| Mr. Thomas R. O'Bryan
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5791
|
| Ms. Tena Bellovich
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5792
|
| Ms. Karen Ausfahl
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5793
|
| Miss. Kristen Hammond
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5794
|
| Ms. melissa Warrenburg
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5795
|
| House of Grace
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5796
|
| Miss. Lisa Perez
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5797
|
| Mrs. Lynn Sucorowski
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5798
|
| Mrs. Helen Halton
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5799
|
| Ms. Claudia Tomaso
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5800
|
| Mr. Nicholas Frederick
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5801
|
| Ms. vriginia sullivan
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5802
|
| Mrs. Tammy O'Neill
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5803
|
| Ms. diana ellis
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5804
|
| Mrs. Marsha Ross
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5805
|
| Ms. MARILYN MAINES
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5806
|
| Mr. Edward Jasiewicz
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5807
|
| Mrs. Diana Bier
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5808
|
| Mrs. Carolina Pachon
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5809
|
| Mrs. Carolyn Bamberger
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5810
|
| Ms. Beverly Ackerman
|
| Vol #:
|
| 60
|
|
| | | | | | | |
|
| |
|
| EC 5811
|
| AARP
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5812
|
| Miss. Melinda Fink
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5813
|
| Mrs. Naomi Greenfield
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5814
|
| Ms. Virginia Ansbergs
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5815
|
| Ms. Kathleen Flannery
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5816
|
| Ms. Jessica S
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5817
|
| Nashville Cat Rescue
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5818
|
| Miss. Daniela Vosseler
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5819
|
| Ms. Vicky Voght
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5820
|
| none
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5821
|
| Mrs. Tezel Relyea
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5822
|
| N/A
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5823
|
| VeridianChicago
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5824
|
| Ms. Cynthia Adams
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5825
|
| Mrs. dina castillo
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5826
|
| Ms. Barbara Evins
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5827
|
| Mr. Dennis Amaya
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5828
|
| individual
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5829
|
| juris doctor of law
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5830
|
| Ms. alexa joy morgan
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5831
|
| Mr. Clay Olson
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5832
|
| Ms. marion frazier
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5833
|
| Mrs. Laurie Milani
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5834
|
| Mrs. Kristine Kelly
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5835
|
| Ms. Shelly Allen
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5836
|
| Ms. Serine Steinnes
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5837
|
| Ms. Jaimi Haig
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5838
|
| Mrs. Patricia Webb
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5839
|
| Ms. Theresa Acerro
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5840
|
| Mrs. Erin McGovney
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5841
|
| Ms. Jackie Pomies
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5842
|
| UC BERKELEY
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5843
|
| Mr. Daniel Dieck
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5844
|
| Ms. Sandra Walters
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5845
|
| Ms. Patricia Archuleta
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5846
|
| Ms. Marjorie Rathbone
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5847
|
| Mr. Ciaran Mercier
|
| Vol #:
|
| 60
|
|
| | | | | | | |
|
| |
|
| EC 5848
|
| Ms. Candace Beck
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5849
|
| Mr. John White
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5850
|
| Ms. Nanette Leslie-Tufts
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5851
|
| Ms. Emily Bragonier
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5852
|
| Mr. Jack Dawson
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5853
|
| Ms. Melissa Roscoe
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5854
|
| Ms. Marianne Daniels
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5855
|
| Mrs. Rebecca LeClaire
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5856
|
| Miss. johana ortiz
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5857
|
| Ms. Monica Sinforosa
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5858
|
| Ms. Lisa Chandler
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5859
|
| Individual Consumer
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5860
|
| Mr. Albert Fecko
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5861
|
| Ms. Rose Sheridan
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5862
|
| Mrs. Donna Burden
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5863
|
| Union County Peace Council
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5864
|
| Ms. merle neidell
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5865
|
| Mrs. Mary Santomauro
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5866
|
| Ms. Vickie Brown
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5867
|
| Mrs. Nelda Bauer
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5868
|
| Ms. Nina Council
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5869
|
| Ms. leslie strano
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5870
|
| Ms. Jessie Casteel
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5871
|
| Miss. Lauren Barker
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5872
|
| Dr. Peter Seidman
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5873
|
| Ms. Sally Diehl
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5874
|
| Ms. Linda Husted
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5875
|
| Ms. Kellie Bryant
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5876
|
| Mrs. Karla Deacon
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5877
|
| Ms. Meghan Harding
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5878
|
| Mr. Kevin Sanders
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5879
|
| Ms. Karen Butterworth
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5880
|
| Ms. Katherine Babiak
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5881
|
| Mrs. patty macdonald
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5882
|
| Lil' MDGs
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5883
|
| Miss. Jessica Velez
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5884
|
| Mr. Bob Blumenthal
|
| Vol #:
|
| 60
|
|
| | | | | | | |
|
| |
|
| EC 5885
|
| Miss. Cynthia Spatafore
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5886
|
| Ms. Deanka Grisham
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5887
|
| Ms. Janet Frey
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5888
|
| Mrs. Christina Ryan
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5889
|
| Ms. elizabeth ooms
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5890
|
| Mrs. Heather Savino
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5891
|
| Mrs. Geraldine Dierks
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5892
|
| Mr. Michael Rohde
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5893
|
| Ms. Mary Hitchcock
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5894
|
| Mrs. Liane Kirby
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5895
|
| Ms. Sharon Buazard
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5896
|
| Ms. Dawn Birdsill
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5897
|
| Ms. Annah Gardner
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5898
|
| Ms. Suzen Riley
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5899
|
| Mrs. Margot VanEtten
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5900
|
| Dr. vera hill
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5901
|
| Mrs. Natalia Neal
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5902
|
| Ms. Kimberly Moses
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5903
|
| Ms. Bernadette LaManna
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5904
|
| Ms. Trish Hib
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5905
|
| Miss. Julianne C.
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5906
|
| Dr. Valerie Myles
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5907
|
| Ms. Jessica Manganello
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5908
|
| Mrs. Holly Chisholm
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5909
|
| Ms. Nia G
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5910
|
| Mrs. Gail Rocco
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5911
|
| Mrs. Susan Clay
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5912
|
| Ms. Debbie Gadbois
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5913
|
| Ms. Bonnie Pustay
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5914
|
| Ms. Francine Hasenbein
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5915
|
| Ms. Suzanne Cook
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5916
|
| Ms. RJ Browne
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5917
|
| Ms. Kaitlyn McKee
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5918
|
| Miss. Ann Edelberg
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5919
|
| Ms. Jane Lischer
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5920
|
| Ms. Mary Ann Wilson
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5921
|
| Mrs. Christa Dailey
|
| Vol #:
|
| 60
|
|
| | | | | | | |
|
| |
|
| EC 5922
|
| Ms. Amber Walker
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5923
|
| None
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5924
|
| Ms. Joann Hill
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5925
|
| Miss. Rochelle Baca
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5926
|
| Mr. Craig kleber
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5927
|
| Mr. David Morrical
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5928
|
| Ms. Sarah Crawford
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5929
|
| Mr. stephen litsinger
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5930
|
| Mrs. Glenda Hoop
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5931
|
| Mrs. Susan Karnatz
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5932
|
| Marquette University
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5933
|
| Mrs. Charlotte Thomas
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5934
|
| Mrs. Deborah Giniewicz
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5935
|
| Mrs. Phyllis Russell
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5936
|
| Mrs. Destiny Melson
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5937
|
| Mrs. Terrie Williams
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5938
|
| self
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5939
|
| Ms. Jennifer Shorey
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5940
|
| Mr. Robert Gilson
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5941
|
| Miss. Denise Lytle
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5942
|
| Richmond SPCA
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5943
|
| Ms. Stephanie Fischer
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5944
|
| Ms. Dani Nichols
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5945
|
| Ms. Katherine Macfarlane
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5946
|
| Ms. Deborah Uhlman
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5947
|
| Ms. Jennie Mugrace
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5948
|
| Mrs. Margery Oberheide
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5949
|
| Ms. Donna Clark
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5950
|
| Ms. Sue Stanton
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5951
|
| Dr. Kim Bates
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5952
|
| N/A
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5953
|
| N/A
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5954
|
| Mrs. Lee Cado
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5955
|
| Ms. Lora Price
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5956
|
| Mrs. Cici Hallberg
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5957
|
| Ms. Sheila Betra
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5958
|
| Mr. michael kemp
|
| Vol #:
|
| 60
|
|
| | | | | | | | |
|
| |
|
| EC 5959
|
| none
|
| Vol #:
|
| 60
|
| |
|
|
| EC 5960
|
| Mrs. MARTHA POWELL
|
| Vol #:
|
| 60
|
|
| |
|
| 2004E-0307
|
| Patent Extension for ALIMTA (pemetrexed), U.S. Patent No. 5,344,932
|
| |
|
|
| CEP 1
|
| U.S. Patent and Trademark Office to Eli Lilly and Company
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0394
|
| Patent Extension for ALOXI (palonosetron hydrochloride) injection, U.S. Patent No. 5,202,333
|
| |
|
|
| CEP 1
|
| U.S. Patent and Trademark Office ot Roche Palo Alto
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0445
|
| Patent Extension for HUMIRA (adalimumab), U.S. Patent No. 6,090,382
|
| |
|
|
| CEP 1
|
| U.S. Patent and Trademark Office to Abbott Laboratories
|
| Vol #:
|
| 1
|
| |
|
|
| 2005E-0258
|
| Patent Term Extension Application for OMACOR, U.S. Patent No. 5, 656,667
|
| |
|
|
| CEP 1
|
| U.S. Patent and Trademark Office to Buchanan Ingersol PC
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C 18298
|
| M. Amador
|
| Vol #:
|
| 198
|
| |
|
|
| C 18299
|
| P. Nagle
|
| Vol #:
|
| 198
|
| |
|
|
| C 18300
|
| J. Klemme
|
| Vol #:
|
| 198
|
|
| |
|
| 2006D-0480
|
| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
|
| |
|
|
| EC 1
|
| Mr. WRC Smith
|
| Vol #:
|
| 6
|
| |
|
|
| EC 2
|
| Ms. Celia Bucci
|
| Vol #:
|
| 6
|
| |
|
|
| EC 3
|
| AMTA
|
| Vol #:
|
| 6
|
| |
|
|
| EC 4
|
| Natural Solutions Foundation
|
| Vol #:
|
| 6
|
| |
|
|
| EC 5
|
| Mr. Paul Klinkman
|
| Vol #:
|
| 6
|
| |
|
|
| EC 6
|
| Ms. Laura Pappis
|
| Vol #:
|
| 6
|
| |
|
|
| EC 7
|
| Mr. Timothy Geib
|
| Vol #:
|
| 6
|
| |
|
|
| EC 8
|
| Mrs. jeanette kempton
|
| Vol #:
|
| 6
|
| |
|
|
| EC 9
|
| N/A
|
| Vol #:
|
| 6
|
| |
|
|
| EC 10
|
| Mr. Steven Opresnick
|
| Vol #:
|
| 6
|
| |
|
|
| EC 11
|
| CDI
|
| Vol #:
|
| 6
|
| |
|
|
| EC 12
|
| Ms. Eileen Barrett
|
| Vol #:
|
| 6
|
| |
|
|
| EC 13
|
| Mr. C A Cohen
|
| Vol #:
|
| 6
|
| |
|
|
| EC 14
|
| Mr. Reginald Wells
|
| Vol #:
|
| 6
|
| |
|
|
| EC 15
|
| Mrs. Linda Nedderman
|
| Vol #:
|
| 6
|
| |
|
|
| EC 16
|
| Ms. Dawn Meyer
|
| Vol #:
|
| 6
|
| |
|
|
| EC 17
|
| Ms. Marnia Robinson
|
| Vol #:
|
| 6
|
| |
|
|
| EC 18
|
| Ms. Joy Dolci
|
| Vol #:
|
| 6
|
|
| | | | | | | | |
|
| |
|
| EC 19
|
| Mrs. Anne Guy
|
| Vol #:
|
| 6
|
| |
|
|
| EC 20
|
| Dr. Don Schwartz
|
| Vol #:
|
| 6
|
| |
|
|
| EC 21
|
| Ms. Laurie Hoppe
|
| Vol #:
|
| 6
|
| |
|
|
| EC 22
|
| Mr. joe corcoran
|
| Vol #:
|
| 6
|
| |
|
|
| EC 23
|
| Mr. Dan Corson-Knowles
|
| Vol #:
|
| 6
|
| |
|
|
| EC 24
|
| Mr. John Witmeyer
|
| Vol #:
|
| 6
|
| |
|
|
| EC 25
|
| Mrs. E Whiteford
|
| Vol #:
|
| 6
|
| |
|
|
| EC 26
|
| Ms. Leila Gill
|
| Vol #:
|
| 6
|
| |
|
|
| EC 27
|
| Mr. Richard Hammond
|
| Vol #:
|
| 6
|
| |
|
|
| EC 28
|
| Ms. Francine Kohn
|
| Vol #:
|
| 6
|
| |
|
|
| EC 29
|
| Ms. Anita Garvey
|
| Vol #:
|
| 6
|
| |
|
|
| EC 30
|
| Ms. Carolyn Piel
|
| Vol #:
|
| 6
|
| |
|
|
| EC 31
|
| Mrs. Magdalene Piel
|
| Vol #:
|
| 6
|
| |
|
|
| EC 32
|
| Mr. Mike Hedge
|
| Vol #:
|
| 6
|
| |
|
|
| 2006E-0003
|
| Patent Extension Application for BiDIL (combination of hydralazine hydrochloride and isosorbide dinitrate), U.S. Patent No. 4,868,179
|
| |
|
|
| LET 2
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0026
|
| Patent Extension Application for Luveris (recombinant human luteinizing hormone), U.S. Patent No. 5,639,639
|
| |
|
|
| CEP 1
|
| U.S. Patent and Trademark Office to Browdy and Neimark, P.L.L.C.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0525
|
| Supplements and Other Changes to an Approved Application
|
| |
|
|
| C 6
|
| Jerussi Consulting Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0015
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Adoption of the FDA Food Code by Local, State, and Tribal Governments
|
| |
|
|
| EMC 2
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
| |
|
| 2007N-0114
|
| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
|
| |
|
|
| LST 1
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| Agenda for April 27, 2007 Public Hearing
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| Vol #:
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| 1
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| EMC 2
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| B. Stuart
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| Vol #:
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| 4
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| EMC 3
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| D. Segner
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| Vol #:
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| 4
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| EMC 4
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| L. Nickols
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| Vol #:
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| 4
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| EMC 5
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| D. Shaw
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| Vol #:
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| 4
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| EMC 6
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| M. Wiltse
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| Vol #:
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| 4
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| EMC 7
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| S. Saint
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| Vol #:
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| 4
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| EMC 8
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| R. Craven
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| Vol #:
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| 4
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| EMC 9
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| A. Snyder
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| Vol #:
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| 4
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| EMC 10
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| No Signature
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| Vol #:
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| 4
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| EMC 11
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| J. Pournelle
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| Vol #:
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| 4
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| EMC 12
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| A. Simmons
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| Vol #:
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| 4
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| EMC 13
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| S. Lyon
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| Vol #:
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| 4
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| EMC 14
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| M. Heller
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| Vol #:
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| 4
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| EMC 15
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| L. Sterne
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| Vol #:
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| 4
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| EMC 16
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| D. Tucker
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| Vol #:
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| 4
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| EMC 17
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| M.
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| Vol #:
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| 4
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| EMC 18
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| M.
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| Vol #:
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| 4
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| EMC 19
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| J. Abshier
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| Vol #:
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| 4
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| EMC 20
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| A. & D. Cellier
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| Vol #:
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| 4
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| EMC 21
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| R. Holmes
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| Vol #:
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| 4
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| EMC 22
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| J. Thompson
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| Vol #:
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| 4
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| EMC 23
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| S. Harrington
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| Vol #:
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| 4
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| EMC 24
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| P. Raulerson
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| Vol #:
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| 4
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| EMC 25
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| M. Wiedau-Pazos
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| Vol #:
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| 4
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| EMC 26
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| A. Watson
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| Vol #:
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| 4
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| EMC 27
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| S. Meric
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| Vol #:
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| 4
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| EMC 28
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| W. Fields
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| Vol #:
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| 4
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| EMC 29
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| Allianz Global Risks US Insurance Company
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| Vol #:
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| 4
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| EMC 30
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| K. Pennington
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| Vol #:
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| 4
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| EMC 31
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| M. Nanjo
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| Vol #:
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| 4
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| EMC 32
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| J.
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| Vol #:
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| 4
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| EMC 33
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| D. Krause
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| Vol #:
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| 4
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| EMC 34
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| D. Roberts
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| Vol #:
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| 4
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| EMC 35
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| www.triactive.com
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| Vol #:
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| 4
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| EMC 36
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| J. Sherman
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| Vol #:
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| 4
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| EMC 37
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| T. Marston
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| Vol #:
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| 4
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| EMC 38
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| J. Kyle
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| Vol #:
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| 4
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| EMC 39
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| S.
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| Vol #:
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| 4
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| EMC 40
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| B.
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| Vol #:
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| 4
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| EMC 41
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| D. Pettit
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| Vol #:
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| 4
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| EMC 42
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| J. McIrvin
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| Vol #:
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| 4
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| EMC 43
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| R. DuBose
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| Vol #:
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| 4
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| EMC 44
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| Ad Astra Games
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| Vol #:
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| 4
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| EMC 45
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| P. Mihok
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| Vol #:
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| 4
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| EMC 46
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| C. de Longpre
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| Vol #:
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| 4
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| EMC 47
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| T. Craver
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| Vol #:
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| 4
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| EMC 48
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| M. Strohschein
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| Vol #:
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| 4
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| EMC 49
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| B. Sell
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| Vol #:
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| 4
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| EMC 50
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| T. Weaver
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| Vol #:
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| 4
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| EMC 51
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| R. Lawton
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| Vol #:
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| 4
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| EMC 52
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| H. Boyle
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| Vol #:
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| 4
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| |
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| EMC 53
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| No Signature
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| Vol #:
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| 4
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| |
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| EMC 54
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| D. Van Wagner
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| Vol #:
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| 4
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| |
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| EMC 55
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| Southwestern College-School of Languages and Humanities
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| Vol #:
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| 4
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| EMC 56
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| R. Juhl
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| Vol #:
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| 4
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| EMC 57
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| B. Dust
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| Vol #:
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| 4
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| EMC 58
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| B. Beyer
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| Vol #:
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| 4
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| EMC 59
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| H. Aust
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| Vol #:
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| 4
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| |
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| EMC 60
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| A. May
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| Vol #:
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| 4
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| |
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| EMC 61
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| B. Parsons
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| Vol #:
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| 4
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| |
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| EMC 62
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| F. Sauer
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| Vol #:
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| 4
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| |
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| EMC 63
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| K. Lowe
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| Vol #:
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| 4
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| |
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| EMC 64
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| D. Schnebly
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| Vol #:
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| 4
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| |
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| 2007P-0159
|
| Take prompt enforecment actions due to the clearly defined public health risk of Toxic Anterior Segment Syndrome (TASS) and secure the removal of illegally marketed unapproved ophthalmic Balanced Salt
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|
|
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| ACK 1
|
| FDA/DDM to Alcon Research, Ltd.
|
| Vol #:
|
| 1
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| |
|
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| CP 1
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| Alcon Research, Ltd.
|
| Vol #:
|
| 1
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