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| Dockets Entered
On May 21, 2007
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| Docket #
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| Title
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| 2002E-0156
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| Galileo Intravascular Radiotherapy System
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| 2004D-0198
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
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| 2004D-0443
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| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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| 2004E-0398
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| Patent Extension for IRESSA (gefitinib), U.S. Patent No. 5,770,599
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| 2004N-0234
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| Annual Guidance Agenda
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| 2005D-0348
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| Guidance for Industry and Food and Drug Administration: Procedures for Handling Post-Approval Studies Imposed by PMA Order
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| 2006D-0190
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Olfactory Test Device; Availability
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| 2006D-0226
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| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
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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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| 2006N-0278
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Develo
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| 2006N-0465
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| Improving Patient Safety by Enhancing the Container Labeling for Parenteral Infusion Drug Products; Public Meeting
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| 2006N-0525
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| Supplements and Other Changes to an Approved Application
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| 2006P-0508
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| Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
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| 2007A-0087
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| Request for an advisory opinion with respect to the FDA's interpretation of 21CFR314.70(c)(6)(iii) regarding NDAs to implement safety-related changes to prescription drug labeling
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| 2007D-0031
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| Global Harmonization Task Force, Study Groups 1, 2, and 4; New Proposed and Final Documents; Availability
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| 2007D-0101
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| Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
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| 2007E-0066
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| Patent Term Extension for NOXAFIL (posaconazole), U.S. Patent No. 5,661,151
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| 2007N-0068
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| Medical Device User Fee and Modernization Act: Public Meeting
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| 2007N-0090
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| Zimulti Endocrinologic and Metabolic Drugs Advisory Committee Meeting, June 13, 2007
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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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| 2007N-0195
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| Science Board to the Food and Drug Administration; Notice of Meeting
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| 2007P-0028
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| Determine whether Seroquel, 150 mg ( quetiapine fumarate ) tablets ( NDA 20-639 ) has been withdrawn for safety or effectiveness reasons
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| 2007P-0044
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| Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
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| 2007P-0070
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| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
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| 2007P-0079
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| To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
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| 2007P-0097
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| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
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| 2007P-0205
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| Withdraw approval of and recall all available stock of Ziana or require the immediate initiation of long-term safety studies evaluating the incidence and prevalence of antibiotic resistance associated
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| 2002E-0156
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| Galileo Intravascular Radiotherapy System
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| N 1
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| FDA
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| Vol #:
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| 2
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| 2004D-0198
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
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| EC 9
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| Ms. Caroline Miles
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| Vol #:
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| 1
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| 2004D-0443
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| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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| EC 13
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| Ms. charisse Texeira
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| Vol #:
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| 2
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| 2004E-0398
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| Patent Extension for IRESSA (gefitinib), U.S. Patent No. 5,770,599
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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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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| N 8
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| FDA
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| Vol #:
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| 1
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| 2004N-0234
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| Annual Guidance Agenda
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| EC 6
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| Mr. GW Seals
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| Vol #:
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| 6
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| EC 7
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| Miss. Anouk Besson
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| Vol #:
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| 1
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| EC 9
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| Ms. charisse texeira
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| Vol #:
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| 1
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| EC 10
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| NONE
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| Vol #:
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| 1
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| 2005D-0348
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| Guidance for Industry and Food and Drug Administration: Procedures for Handling Post-Approval Studies Imposed by PMA Order
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| EC 4
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| Ms. charisse texeira
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| Vol #:
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| 1
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| 2006D-0190
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Olfactory Test Device; Availability
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| EC 2
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| Ms. charisse Texeira
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| 1
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| 2006D-0226
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| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
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| EC 20
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| Mr. Thomas Spann
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| Vol #:
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| 1
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| EC 21
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| Ms. Jodian Jones
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| Vol #:
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| 1
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| EC 22
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| Self
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| Vol #:
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| 1
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| EC 23
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| Mr. Jerk Asaurus
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| Vol #:
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| 1
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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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| EC 195
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| Ms. Stephanie Lawner
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| Vol #:
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| 6
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| EC 196
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| Mr. Thomas Pula
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| Vol #:
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| 6
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| 2006N-0278
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Develo
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| N 2
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| FDA
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| Vol #:
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| 1
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| 2006N-0465
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| Improving Patient Safety by Enhancing the Container Labeling for Parenteral Infusion Drug Products; Public Meeting
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| EC 2
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| Ameican Society of Health-System Pharmacists
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| Vol #:
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| 1
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| 2006N-0525
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| Supplements and Other Changes to an Approved Application
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| EC 13
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| Teva Pharmaceutical Industries Ltd.
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| Vol #:
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| 1
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| EC 14
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| Mr. Fred Razzaghi
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| Vol #:
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| 4
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| EC 15
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| Mr. Fred Razzaghi
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| Vol #:
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| 1
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| EC 16
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| United States Pharmacopeia
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| Vol #:
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| 1
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| EC 14
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| University of Uppsala, Sweden
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| Vol #:
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| 1
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| 2006P-0508
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| Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
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| EC 3
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| Dr. Jeffrey Miskoff
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| Vol #:
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| 1
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| EC 4
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| Mr. Kevin O'Brien
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| Vol #:
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| 1
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| 2007A-0087
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| Request for an advisory opinion with respect to the FDA's interpretation of 21CFR314.70(c)(6)(iii) regarding NDAs to implement safety-related changes to prescription drug labeling
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| EC 1
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| Ms. Charisse P Texeira
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| Vol #:
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| 1
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| 2007D-0031
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| Global Harmonization Task Force, Study Groups 1, 2, and 4; New Proposed and Final Documents; Availability
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| EC 1
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| Pfizer Inc
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| Vol #:
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| 1
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| 2007D-0101
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| Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
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| C 2
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| Wyeth Pharmaceuticals
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| Vol #:
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| 1
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| EC 15
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| Mr. Kenneth McGuire
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| Vol #:
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| 1
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| EC 16
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| Mr. John R. Polito
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| Vol #:
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| 1
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| EC 17
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| Emory University
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| Vol #:
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| 1
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| EC 18
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| National Organization for Rare Disorders (NORD)
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| Vol #:
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| 1
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| EC 19
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| Mr. James Ponto
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| Vol #:
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| 1
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| EC 20
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| University of Iowa
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| Vol #:
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| 1
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| EC 21
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| Mr. Jeremy Gilsoul
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| Vol #:
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| 1
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| EC 22
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| Dr. Raj Rao
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| Vol #:
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| 1
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| EC 23
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| Dr. David Nelson
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| Vol #:
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| 1
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| EC 24
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| Center for Science in the Public Interest
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| Vol #:
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| 1
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| EC 25
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| Dr. Andrew Ku
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| Vol #:
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| 1
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| EC 26
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| Dr. Jay Markowitz
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| Vol #:
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| 1
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| EC 27
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| Ms. Kristin Keckeisen
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| Vol #:
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| 1
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| EC 28
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| Dr. Peter Amadio
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| Vol #:
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| 1
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| EC 29
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| University of Florida
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| Vol #:
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| 1
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| EC 30
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| American Society of Health-System Pharmacists
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| Vol #:
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| 1
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| EC 31
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| Dr. Kenneth Moore
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| Vol #:
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| 1
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| EC 32
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| Parkinson Pipeline Project
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| Vol #:
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| 1
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| EC 33
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| Breast Cancer Action
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| Vol #:
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| 1
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| 2007E-0066
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| Patent Term Extension for NOXAFIL (posaconazole), U.S. Patent No. 5,661,151
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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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| |
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| 2007N-0068
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| Medical Device User Fee and Modernization Act: Public Meeting
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| C 1
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| American Academy of Orthopaedic Surgeons
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| Vol #:
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| 1
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| C 2
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| Dade Behring Inc
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| Vol #:
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| 1
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| EC 7
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| Ms. Sharon Scannell
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| Vol #:
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| 1
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| EC 8
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| American Heart Association
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| Vol #:
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| 1
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| 2007N-0090
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| Zimulti Endocrinologic and Metabolic Drugs Advisory Committee Meeting, June 13, 2007
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| EC 1
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| Mr. Marc Prisament
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| Vol #:
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| 1
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| EC 2
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| Ms. Pamela Newton
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| Vol #:
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| 1
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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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| EAPE 207
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| Tyler, Robyn
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| Vol #:
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| 7
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| EAPE 208
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| Pierce, William
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| Vol #:
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| 7
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| EAPE 209
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| Sutton, Jill
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| Vol #:
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| 7
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| EAPE 210
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| Sutton, Jill
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| Vol #:
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| 7
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| EAPE 211
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| Flottman, Thomas
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| Vol #:
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| 7
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| EAPE 212
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| Mayberry, Peter
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| Vol #:
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| 7
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| EAPE 213
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| Hoerner, Paul
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| Vol #:
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| 7
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| EAPE 214
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| Trott, Jayme
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| Vol #:
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| 7
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| 2007N-0195
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| Science Board to the Food and Drug Administration; Notice of Meeting
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| NM 1
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| FDA
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| Vol #:
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| 1
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| 2007P-0028
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| Determine whether Seroquel, 150 mg ( quetiapine fumarate ) tablets ( NDA 20-639 ) has been withdrawn for safety or effectiveness reasons
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| EC 2
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| Mrs. deborah cook
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| Vol #:
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| 1
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| 2007P-0044
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| Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
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| EC 5
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| Ms. Caroline Miles
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| Vol #:
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| 1
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| 2007P-0070
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| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
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| EC 8
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| Mr. Steven Opresnick
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| Vol #:
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| 1
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| EC 9
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| Ms. Cheryl Jones
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| Vol #:
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| 1
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| EC 10
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| Miss. Stacia Gondusky
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| Vol #:
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| 1
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| EC 11
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| Mr. Lawrence Austin
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| Vol #:
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| 1
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| EC 12
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| Ms. Joanne Holcomb
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| Vol #:
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| 1
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