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| Dockets Entered
On March 20, 2007
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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| 2000V-1576
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| AN/PEQ-2A, Target Pointer-Illuminator/Aiming Light
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| 2003N-0143
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| Continued Over-the-Counter Status of Ipecac Syrup
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| 2005N-0373
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| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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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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| 2006N-0061
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| Charging for Investigational Drugs
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| 2006N-0062
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| Expanded Access to Investigational Drugs for Treatment Use
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| 2006N-0187
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Survey of Health Care Professionals on the Food Safety and Nutrition Information that they Provide to Pregnant Women
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| 2006P-0144
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| delalutin hydroxyprogesterone caproate) Injection was not withdrawn for safety or effectiveness reasons and therefore suibable for ANDA
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| 2006P-0390
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| Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
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| 2007P-0103
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| to permit an ANDA Suitability for Carvedilol phosphate Tablets
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| 2007V-0102
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| Projector for a Laser Light Show
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 19521
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| NOW Foods
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| Vol #:
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| 173
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| LET 19522
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| NOW Foods
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| Vol #:
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| 173
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| LET 19523
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| NOW Foods
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| Vol #:
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| 173
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| LET 19524
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| NOW Foods
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| Vol #:
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| 173
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| LET 19525
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| NOW Foods
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| Vol #:
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| 173
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| LET 19526
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| NOW Foods
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| Vol #:
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| 173
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| LET 19527
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| NOW Foods
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| Vol #:
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| 173
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| LET 19528
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| NOW Foods
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| Vol #:
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| 173
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| LET 19529
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| NOW Foods
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| Vol #:
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| 173
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| LET 19530
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| NOW Foods
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| Vol #:
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| 173
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| LET 19531
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| NOW Foods
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| Vol #:
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| 173
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| LET 19532
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| NOW Foods
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| Vol #:
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| 173
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| LET 19533
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| NOW Foods
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| Vol #:
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| 173
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| LET 19534
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| NOW Foods
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| Vol #:
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| 173
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| LET 19535
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| NOW Foods
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| Vol #:
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| 173
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| LET 19536
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| NOW Foods
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| Vol #:
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| 173
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| LET 19537
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| NOW Foods
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| Vol #:
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| 173
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| LET 19538
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| NOW Foods
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| Vol #:
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| 173
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| LET 19539
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| NOW Foods
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| Vol #:
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| 173
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| LET 19540
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| NOW Foods
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| Vol #:
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| 173
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| LET 19541
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| NOW Foods
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| Vol #:
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| 173
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| LET 19542
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| NOW Foods
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| Vol #:
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| 173
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| LET 19543
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| NOW Foods
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| Vol #:
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| 173
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| LET 19544
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| AdvoCare International, L.P.
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| Vol #:
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| 173
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| LET 19545
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| Aboca USA Inc.
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| Vol #:
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| 173
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| LET 19546
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| Enhansulin.com Corp.
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| Vol #:
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| 173
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| LET 19547
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| Shining Mountain Herbs
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| Vol #:
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| 173
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| LET 19548
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| Shining Mountain Herbs
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| Vol #:
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| 173
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| LET 19549
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| Garden of Life, Inc.
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| Vol #:
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| 173
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| LET 19550
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| Garden of Life, Inc.
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| Vol #:
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| 173
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| LET 19551
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| Garden of Life, Inc.
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| Vol #:
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| 173
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| LET 19552
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| Garden of Life, Inc.
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| Vol #:
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| 173
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| LET 19553
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| Garden of Life, Inc.
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| Vol #:
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| 173
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| LET 19554
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| Univera LifeSciences, Inc.
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| Vol #:
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| 173
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| LET 19555
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| Univera LifeSciences, Inc.
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| Vol #:
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| 173
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| LET 19556
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| Univera LifeSciences, Inc.
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| Vol #:
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| 173
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| LET 19557
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| Univera LifeSciences, Inc.
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| Vol #:
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| 173
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| LET 19558
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| Univera LifeSciences, Inc.
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| Vol #:
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| 173
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| LET 19559
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| Univera LifeSciences, Inc.
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| Vol #:
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| 173
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| 2000V-1576
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| AN/PEQ-2A, Target Pointer-Illuminator/Aiming Light
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| AMD 1
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| Insight Technology Incorporated
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| Vol #:
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| 1
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| 2003N-0143
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| Continued Over-the-Counter Status of Ipecac Syrup
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| C 8
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| J Oamhi
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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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| C 392
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| C.Reeves
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| Vol #:
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| 41
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| C 393
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| J. Adams
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| Vol #:
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| 41
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| C 394
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| G. Ortiz
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| Vol #:
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| 41
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| C 395
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| J. Betz
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| Vol #:
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| 41
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| C 396
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| M. Resso
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| Vol #:
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| 41
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| C 397
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| V. Maresh
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| Vol #:
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| 41
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| C 398
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| M. Casolara
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| Vol #:
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| 41
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| C 399
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| J. Flake
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| Vol #:
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| 41
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| C 400
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| J. Thixton
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| Vol #:
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| 41
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| C 401
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| J. Devillers
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| Vol #:
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| 41
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| C 402
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| D. Goad
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| Vol #:
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| 41
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| C 403
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| P. Sennett
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| Vol #:
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| 41
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| C 404
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| R. Levacy
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| Vol #:
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| 41
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| C 405
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| M. Engebretson
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| Vol #:
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| 41
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| C 406
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| M. Engebretson
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| Vol #:
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| 41
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| C 407
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| A. Marie
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| Vol #:
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| 41
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| C 408
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| J. Hillman
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| Vol #:
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| 41
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| C 409
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| J. Houland
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| Vol #:
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| 41
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| C 410
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| N. Walker
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| Vol #:
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| 41
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| C 411
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| K. Scott
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| Vol #:
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| 41
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| C 412
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| M. Slakey
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| Vol #:
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| 41
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| C 413
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| V. Roce
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| Vol #:
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| 41
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| C 414
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| B. Shales
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| Vol #:
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| 41
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| C 415
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| D. Faulker
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| Vol #:
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| 41
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| EC 1823
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| Ms. Deborah Cramer
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| Vol #:
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| 31
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| EC 1824
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| Ms. Allison Friedman
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| Vol #:
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| 31
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| EC 1825
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| Ms. Thomas Innes
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| Vol #:
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| 31
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| EC 1826
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| Mrs. Norma Muriel
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| Vol #:
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| 31
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| EC 1827
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| Mr. Michael Ryan
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| Vol #:
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| 31
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| EC 1828
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| Miss. Gail Granucci
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| Vol #:
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| 31
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| EC 1829
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| Ms. Lillian Thompson
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| Vol #:
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| 31
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| EC 1830
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| Ms. Sheryl Tacy
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| Vol #:
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| 31
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| EC 1831
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| Ciliac.com member
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| Vol #:
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| 31
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| EC 1832
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| concerned individul
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| Vol #:
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| 31
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| EC 1833
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| Miss. Sarah Coville
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| Vol #:
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| 31
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| EC 1834
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| Mr. Brian Rutledge
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| Vol #:
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| 31
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| EC 1835
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| Ms. Elaine Edington
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| Vol #:
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| 31
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| EC 1836
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| Dr. Stephen Carroll
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| Vol #:
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| 31
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| EC 1837
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| Mrs. Pamela Sweet
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| Vol #:
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| 31
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| EC 1838
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| Mrs. Julie Powers
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| Vol #:
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| 31
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| EC 1839
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| Ms. Chris Stone
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| Vol #:
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| 31
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| EC 1840
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| Ind.
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| Vol #:
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| 31
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| EC 1841
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| Mrs. L. McCliment
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| Vol #:
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| 31
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| EC 1842
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| Ms. Lorie cannon
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| Vol #:
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| 31
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| EC 1843
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| Mrs. Luanne Lowe
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| Vol #:
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| 31
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| EC 1844
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| Mrs. Arbena Moss
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| Vol #:
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| 31
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| EC 1845
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| Miss. Brenda Batyske
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| Vol #:
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| 31
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| EC 1846
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| Mrs. Wendy Wiswell
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| Vol #:
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| 31
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| EC 1847
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| Dr. Nancy Goldin
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| Vol #:
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| 31
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| EC 1848
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| Ms. K. Carter
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| Vol #:
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| 31
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| EC 1849
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| Mrs. A. McGregor
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| Vol #:
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| 31
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| EC 1850
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| Mrs. Toleah Christman
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| Vol #:
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| 31
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| EC 1851
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| Miss. Jana Ervine
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| Vol #:
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| 31
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| |
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| EC 1852
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| Mr. Carl Lucas
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| Vol #:
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| 31
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| EC 1853
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| Mrs. Vicki Brady
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| Vol #:
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| 31
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| EC 1854
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| Mrs. Sandra Simkins
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| Vol #:
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| 31
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| EC 1855
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| Mrs. Joan Knibbe
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| Vol #:
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| 31
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| |
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| 2005N-0373
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| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
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| |
|
|
| EC 9
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| Hematech, Inc.
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| Vol #:
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| 8
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| |
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| EC 10
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| Gelatin Manufacturers Institute of America
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| Vol #:
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| 1
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| |
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| EC 11
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| Bayer HealthCare AG, Leverkusen, Germany
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| Vol #:
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| 1
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| EC 12
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| St. Jude Medical
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| Vol #:
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| 1
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| EC 13
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| Amgen
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| Vol #:
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| 1
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| EC 14
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| Genentech, Inc.
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| Vol #:
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| 1
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| |
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| EC 15
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| Advanced Medical Technology Association
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| Vol #:
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| 1
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| |
|
|
| 2005N-0403
|
| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
|
|
|
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|
|
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| |
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| EREG 5
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| ALK-Abello, Inc.
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| Vol #:
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| 10
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| |
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| EREG 6
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| Cardinal Health, Inc.
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| Vol #:
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| 10
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| |
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| EREG 7
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| N. A. C. D. S.
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| Vol #:
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| 10
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| EREG 8
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| R. Lanton
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| Vol #:
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| 10
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| |
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| EREG 9
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| American Free Trade Association
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| Vol #:
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| 10
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| |
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| EREG 10
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| Wolters Kluwer Health
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| Vol #:
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| 10
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| |
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| EREG 11
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| GS1 US
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| Vol #:
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| 10
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| |
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| EREG 12
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| Hyman, Phelps & McNamara, P. C.
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| Vol #:
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| 10
|
| |
|
|
| 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
|
| |
|
|
| C 18275
|
| C. Crawford
|
| Vol #:
|
| 198
|
| |
|
|
| 2006N-0061
|
| Charging for Investigational Drugs
|
| |
|
|
| C 14
|
| Public Citizen
|
| Vol #:
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| 1
|
|
| | | | | | | | |
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| |
|
| 2006N-0062
|
| Expanded Access to Investigational Drugs for Treatment Use
|
| |
|
|
| C 23
|
| Public Citizen
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0187
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Survey of Health Care Professionals on the Food Safety and Nutrition Information that they Provide to Pregnant Women
|
|
|
|
|
|
|
| |
|
|
| N 2
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2006P-0144
|
| delalutin hydroxyprogesterone caproate) Injection was not withdrawn for safety or effectiveness reasons and therefore suibable for ANDA
|
| |
|
|
| SUP 1
|
| CUSTOpharm, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0390
|
| Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
|
| |
|
|
| EC 22
|
| Mr. Jerry Staton
|
| Vol #:
|
| 1
|
| |
|
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| EC 23
|
| Mr. Jerry Staton
|
| Vol #:
|
| 1
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| |
|
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| EC 24
|
| Mr. Jerry Staton
|
| Vol #:
|
| 1
|
| |
|
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| EC 25
|
| Mr. Jerry Staton
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| FDA/CDRH to J Staton
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0103
|
| to permit an ANDA Suitability for Carvedilol phosphate Tablets
|
| |
|
|
| ACK 1
|
| FDA / DDM to Keller And Heckman LLP
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Keller And Heckman LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2007V-0102
|
| Projector for a Laser Light Show
|
| |
|
|
| ACK 1
|
| FDA / DDM to Technological Artisans
|
| Vol #:
|
| 1
|
| |
|
|
| VAR 1
|
| Technological Artisans
|
| Vol #:
|
| 1
|
|
|
