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| Dockets Entered
On October 27, 2003
Table of Contents
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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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| 2003D-0061
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| Comparability Protocols Chemistry Manufacturing and controls
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| 2003D-0319
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| Guidance for Industry and FDA Staff; Draft; Premarket Assessment of Pediatric Medical Devices
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| 2003D-0349
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| Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
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| 2003D-0367
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic FormatbHuman Pharmaceutical Applications and Related Submissions
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| 2003D-0380
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| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
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| 2003D-0382
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| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
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| 2003D-0412
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| International Conference on Harmonisation; Draft Guidance on E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2003N-0344
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| Consumer-Directed Promotion; Public Meeting
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0494
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| Not approve any new drug application (NDA) for a hyaluronidase product unless the conditions set forth in the petition are satisfied
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| 2003V-0495
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| 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
11361
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| Planetary Formulas
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| Vol #:
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| 87
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| LET
11362
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| Market America, Inc.
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| Vol #:
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| 87
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| LET
11363
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 87
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| LET
11364
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 87
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| LET
11365
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| Tabak's Health Products
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| Vol #:
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| 87
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| LET
11366
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 87
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| LET
11367
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 87
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| LET
11368
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| Perrigo Company of South Carolina
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| Vol #:
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| 87
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| LET
11369
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 87
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| LET
11370
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 87
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| LET
11371
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| The Vitamin Shoppe Industries Inc.
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| Vol #:
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| 87
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| LET
11372
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| Indiana Botanic Gardens, Inc.
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| Vol #:
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| 87
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| LET
11373
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| Botanic Gardens, Inc.
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| Vol #:
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| 87
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| LET
11374
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| New York Healthy Herbs Inc.
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| Vol #:
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| 87
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| LET
11375
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| New York Healthy Herbs Inc.
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| Vol #:
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| 87
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| LET
11376
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| Nutrition Now, Inc.
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| Vol #:
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| 87
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| LET
11377
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 87
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| LET
11378
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| Vitaline Formulas
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| Vol #:
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| 87
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| LET
11379
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| Vitaline Formulas
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| Vol #:
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| 87
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| LET
11380
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| Vitaline Formulas
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| Vol #:
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| 87
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| LET
11381
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| Vitaline Formulas
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| Vol #:
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| 87
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| LET
11382
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| Vitaline Formulas
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| Vol #:
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| 87
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| 2000N-1484
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| Safety Reporting Requirements Human Drug/Biological Products
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| EC 17
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| ROBINETTE, CHARLES
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| Vol #:
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| 6
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| EC 18
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| Waldman, Kathryn
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| Vol #:
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| 6
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| EC 19
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| Waldman, Kathryn
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| Vol #:
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| 6
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| EC 20
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| Waldman, Kathryn
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| Vol #:
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| 6
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| EC 21
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| Jones, Judith K.
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| Vol #:
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| 6
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| EC 22
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| Jones, Judith K.
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| Vol #:
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| 6
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| EC 23
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| Jones, Judith K.
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| Vol #:
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| 6
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| EC 24
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| McClain, John
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| Vol #:
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| 6
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| 2003D-0061
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| Comparability Protocols Chemistry Manufacturing and controls
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| EMC
5
Continued
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| FAME Systems
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| Vol #:
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| 2
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| 2003D-0092
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| Food and Cosmetic Security Guidances
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| EC 6
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| Lindboe, John
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| Vol #:
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| 1
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| 2003D-0319
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| Guidance for Industry and FDA Staff; Draft; Premarket Assessment of Pediatric Medical Devices
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| EMC
1
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| Ethicon Endo-Surgery, Inc.
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| Vol #:
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| 1
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| 2003D-0349
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| Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
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| EMC
1
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| Cambrex Bio Science Walkersville, Inc.
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| Vol #:
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| 1
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| 2003D-0367
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic FormatbHuman Pharmaceutical Applications and Related Submissions
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| EMC
1
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| Merck & Co., Inc. (Merck)
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| Vol #:
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| 1
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| 2003D-0380
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| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
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| EMC
1
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| Novo Nordisk
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| Vol #:
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| 1
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| 2003D-0382
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| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
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| EC 1
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| Andersen, Anita
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| Vol #:
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| 1
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| EC 2
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| Ronninger, Stephan
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| Vol #:
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| 1
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| EMC
4
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| Veltek Asscoiates, Inc. (VAI)
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| Vol #:
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| 1
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| EMC 5
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| La Calhene
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| Vol #:
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| 1
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| EMC 6
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| MJ Crichton, PE
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| Vol #:
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| 1
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| EMC
7
Attachment
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| International Consultants Assn
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| Vol #:
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| 1
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| 2003D-0412
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| International Conference on Harmonisation; Draft Guidance on E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting
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| EMC
1
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| Abbott Laboratories
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| Vol #:
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| 1
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| EMC 1
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| No signature
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| Vol #:
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| 1
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| EMC 2
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| No signature
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| Vol #:
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| 1
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| EMC 3
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| Ann-Maree Rockhold
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| Vol #:
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| 1
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| EMC 4
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| Mary Luchsinger
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| Vol #:
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| 1
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| EMC 5
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| Gretchen Evans Parker
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| Vol #:
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| 1
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| 2003N-0069
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| FDA Task Force on Consumer Health Info for Better Nutrition
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| EC 78
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| Kur, Ted
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| Vol #:
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| 1
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| EC 79
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| Collins, Christopher
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| Vol #:
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| 1
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| EC 81
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| Grudin, Teva
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| Vol #:
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| 1
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| EC 82
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| Proulx, Dorothy
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| Vol #:
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| 1
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| EC 83
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| Stahl, Neil
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| Vol #:
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| 1
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| EC 84
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| Zespy, Linda
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| Vol #:
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| 1
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| 2003N-0294
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| Risk Management Plans for Opiate Analgesic Drug
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| EC 23
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| Fanelli, Richard
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| Vol #:
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| 1
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| EC 24
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| Twillman, Robert
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| Vol #:
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| 1
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| EMC
2
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| Land O' Lakes Farmland Feed, LLC (LOLFL)
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| Vol #:
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| 1
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| 2003N-0338
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| Obesity
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| EC 8
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| perkins, phyllis
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| Vol #:
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| 1
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| EC 9
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| Fischer, Thekla
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| Vol #:
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| 1
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| EC 10
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| Lucile, Linda
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| Vol #:
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| 1
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| EC 11
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| Haddock, Janet
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| Vol #:
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| 1
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| EC 13
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| Peled, Dror
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| Vol #:
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| 1
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| EC 15
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| Bryant, Stacy
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| Vol #:
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| 1
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| EC 16
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| Cole, Elaine Knowles
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| Vol #:
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| 1
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| EC 18
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| Caporale, Lynn
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| Vol #:
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| 1
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| EC 19
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| sachau, barb
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| Vol #:
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| 1
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| EC 20
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| Letterman, Chris
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| Vol #:
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| 1
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| EC 21
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| Little, CAE, Beth A.
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| Vol #:
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| 1
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| EC 22
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| Tiedt, Thomas
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| Vol #:
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| 1
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| EC 25
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| McGeough, John
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| Vol #:
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| 1
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| EC 27
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| Murray, J
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| Vol #:
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| 1
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| EC 28
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| Negrin, Barry
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| Vol #:
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| 1
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| EC 29
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| Garey, Phil
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| Vol #:
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| 1
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| EC 30
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| Hitchcock, Anne
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| Vol #:
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| 1
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| 2003N-0344
|
| Consumer-Directed Promotion; Public Meeting
|
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| EMC 7
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| Carol Snyder
|
| Vol #:
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| 2
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| EMC 8
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| Tim Humphrey
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| Vol #:
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| 2
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| EMC 9
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| Carrie L. Smith
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| Vol #:
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| 2
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| EMC 10
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| Martha Manley Malik, DDS
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| Vol #:
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| 2
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| EMC 11
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| Trinka Porrata
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| Vol #:
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| 2
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| EMC 12
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| Erica Leary
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| Vol #:
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| 2
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| EMC 13
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| James Wesley
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| Vol #:
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| 2
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| EMC
4
Continued
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| International Intellectual Property Institute (IIPI)
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| Vol #:
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| 2
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| EMC 5
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| Dirk R. Verbeek
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| Vol #:
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| 2
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| EMC
6
Attachment 1,
2, 3,
4, 5
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| Molecular Isotope Technologies,
LLC
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| Vol #:
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| 2
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| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
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|
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| EMC 2
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| M.M. Giese
|
| Vol #:
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| 6
|
| |
|
|
| 2003P-0494
|
| Not approve any new drug application (NDA) for a hyaluronidase product unless the conditions set forth in the petition are satisfied
|
| |
|
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| ACK 1
|
| HFA-305 to Baxter Healthcare Corporation
|
| Vol #:
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| 1
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| CP 1
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| Baxter Healthcare Corporation
|
| Vol #:
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| 1
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| 2003V-0495
|
| Laser Light Show
|
| |
|
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| ACK 1
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| HFA-305 to Lasertek F/X
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| Vol #:
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| 1
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| VAR
1
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| Lasertek F/X
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| Vol #:
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| 1
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