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| Dockets Entered
On December 10, 2004
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| Docket #
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| Title
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| 1988N-0413
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| CGMP for Blood and Blood Components; Proficiency Testing req
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| 1989N-0106
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| Shellac and Shellac Wax
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| 2000N-0504
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| Egg Safety Action Plan
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004D-0431
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| Draft Guidance for Industry: Current Good Manufacturing Practices for Combination Products
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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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| |
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| 2004D-0453
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| Compliance Policy Guide Sec. 560.400 - "Imported Milk and Cream Federal Import Milk Act (CPG 7119.05)"
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| 2004D-0499
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| Compliance Policy Guide Sec. 400.210 Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs
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| 2004D-0543
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| Include a Definition for Rice and Rice Wine Vinegar in the Compliance Policy Guide for Vinegar , CPG 7109.22
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004P-0544
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| ANDA for ondansetron hydrochloirde injection, 8mg/4mL prefilled syringes
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| 1988N-0413
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| CGMP for Blood and Blood Components; Proficiency Testing req
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| NWL
2
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| FDA
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| Vol #:
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| 1
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| |
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| 1989N-0106
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| Shellac and Shellac Wax
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 2000N-0504
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| Egg Safety Action Plan
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| EC 3
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| Mr. Joshua Warchol
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| Vol #:
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| 18
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| EC 4
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| Mr. Matthew Alschuler
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| Vol #:
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| 18
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| EC 5
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| Ms. Marika Collins
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| Vol #:
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| 18
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| EC 6
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| Ms. Claudia Cataldo
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| Vol #:
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| 18
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| EC 7
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| none
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| Vol #:
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| 18
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| |
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| EC 8
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| Miss. Paola Pannucci
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| Vol #:
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| 18
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| |
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| EC 9
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| Ms. Tammy McGinley
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| Vol #:
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| 18
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| EC 10
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| Ms. Jackie Miller
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| Vol #:
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| 18
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| EC 11
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| Mrs. Marianne Toth
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| Vol #:
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| 18
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| EC 12
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| Ms. Ana Verastegui
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| Vol #:
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| 18
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| EC 13
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| Mrs. Elena Verastegui
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| Vol #:
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| 18
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| EC 14
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| Mr. Andrew Koshefsky
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| Vol #:
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| 18
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| |
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| EC 15
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| Ms. Teresa Blasius
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| Vol #:
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| 18
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| |
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| EC 16
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| Ms. Nancy Reynolds
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| Vol #:
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| 18
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| |
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| EC 17
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| Ms. Maura Becker
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| Vol #:
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| 18
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| | | | | | | | |
| |
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| EC 18
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| Ms. Victoria McElroy
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| Vol #:
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| 18
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| |
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|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
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| EC 824
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| Dr. Thomas Benton
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| Vol #:
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| 297
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| |
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| EC
825
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| University of Alabama
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| Vol #:
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| 297
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| |
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| EC 826
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| Dr. Nathan Hoeldtke
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| Vol #:
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| 297
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| |
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| EC 827
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| Dr. Joseph DeCook
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| Vol #:
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| 297
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| |
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| EC 828
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| Dr. Angela Jackson
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| Vol #:
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| 297
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| |
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| EC 829
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| Dr. Donna Harrison
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| Vol #:
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| 297
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| |
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| EC 830
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| Dr. Doyce Payne
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| Vol #:
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| 297
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| |
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| EC 831
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| Dr. Christina Cirucci
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| Vol #:
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| 297
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| |
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| EC 832
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| Dr. Earle McGarvah, M.D.
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| Vol #:
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| 297
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| |
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| EC
833
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| The Catholic University of America
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| Vol #:
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| 297
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| |
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| EC
834
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| Albany IVF, Fertility and Gynecology
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| Vol #:
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| 297
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| |
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| EC
835
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| RidgeGate OBGYN
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| Vol #:
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| 297
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| |
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| EC 836
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| Dr. Jennifer Porter
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| Vol #:
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| 297
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| |
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| EC
837
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| American Assoc of ProLife Obstetricians and Gyneco
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| Vol #:
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| 297
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| |
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| EC 838
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| Dr. Mark A. Walker
|
| Vol #:
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| 297
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| |
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| EC 839
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| Dr. Matthew Lee
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| Vol #:
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| 297
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| |
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| EC 840
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| Miss. Elizabeth Massopust
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| Vol #:
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| 297
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| |
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| EC 841
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| Dr. Jerome Klobutcher
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| Vol #:
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| 297
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| |
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| EC 842
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| Dr. Martin A. Allen
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| Vol #:
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| 297
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| EC 843
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| Ms. Angela Macey-Cushman
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| Vol #:
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| 297
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| |
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| EC 844
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| Dr. Kathleen Vincent
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| Vol #:
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| 297
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| |
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| EC 845
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| Dr. Jerry Wittingen
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| Vol #:
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| 297
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| |
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| EC 846
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| Mr. Matt Bennett
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| Vol #:
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| 297
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| |
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| EC
847
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| ACOOG
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| Vol #:
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| 297
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| |
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| EC 848
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| Dr. Mary Davenport
|
| Vol #:
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| 297
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| |
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| EC 849
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| Miss. Elena Hung
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| Vol #:
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| 297
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| |
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| EC 850
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| Ms. Michelle Harrison
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| Vol #:
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| 297
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| |
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| EC 851
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| Ms. Mary Philip
|
| Vol #:
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| 297
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| |
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| EC 852
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| Mr. Peter Kilner
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| Vol #:
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| 297
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| |
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| EC 853
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| Dr. Marshall Matthews
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| Vol #:
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| 297
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| |
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| EC 854
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| Dr. gus barkett
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| Vol #:
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| 297
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| |
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| EC 855
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| Miss. Emily Meehan
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| Vol #:
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| 297
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| |
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| EC 856
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| Mrs. Mary Risley
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| Vol #:
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| 297
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| |
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| EC 857
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| Mrs. Claire Kamp dush
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| Vol #:
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| 297
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|
| | | | | | | | |
| |
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| EC 858
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| Mrs. Katherine Engel
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| Vol #:
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| 297
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| |
|
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| EC 859
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| Mrs. Marilyn Matthews
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| Vol #:
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| 297
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| |
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| EC 860
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| Mrs. Ruza Lasic
|
| Vol #:
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| 297
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| |
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| EC 861
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| Ms. Loretta Yin, Esq.
|
| Vol #:
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| 297
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| |
|
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| EC 862
|
| Mr. George Ahrend
|
| Vol #:
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| 297
|
| |
|
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| EC
863
|
| Dept. of Philosophy, University of Texas at Austin
|
| Vol #:
|
| 297
|
| |
|
|
| EC 864
|
| Mrs. Carolyn Goetten
|
| Vol #:
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| 297
|
| |
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| EC 865
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| Dr. Aaron Dush
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| Vol #:
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| 297
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| |
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| EC 866
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| Mrs. Courtney Kamp
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| Vol #:
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| 297
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| |
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| EC 867
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| Mrs. Audrey Alsobrook
|
| Vol #:
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| 297
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| |
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| EC 868
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| Mrs. Janice Pfeufer
|
| Vol #:
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| 297
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| |
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| EC 869
|
| Mrs. Shelley R. Dush
|
| Vol #:
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| 297
|
| |
|
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| EC 870
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| Mrs. margaret svendsen
|
| Vol #:
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| 297
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| |
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| EC
871
|
| Private practice, Obstetrics/Gynecology
|
| Vol #:
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| 297
|
| |
|
|
| EC 872
|
| Miss. Saly Sebastian
|
| Vol #:
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| 297
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| |
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| EC 873
|
| Mr. Keith Proctor
|
| Vol #:
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| 297
|
| |
|
|
| 2004D-0343
|
| Hospital Bed System Dimensional Guidance to Reduce Entrapment
|
| |
|
|
| EC
12
|
| Loughborough University
|
| Vol #:
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| 2
|
| |
|
|
| EC 13
|
| Mr. Dennis Fox
|
| Vol #:
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| 2
|
| |
|
|
| EC
14
|
| Doctors Hospital Columbus, Georgia
|
| Vol #:
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| 2
|
| |
|
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| EC
15
|
| Franklin Memorial Hospital
|
| Vol #:
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| 2
|
| |
|
|
| EC
16
|
| Greenwich Hospital
|
| Vol #:
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| 2
|
| |
|
|
| EC
17
|
| Stillwater Medical Center
|
| Vol #:
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| 2
|
| |
|
|
| EC
18
|
| Albemarle Hospital
|
| Vol #:
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| 2
|
| |
|
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| EC
19
|
| Longmont United Hospital
|
| Vol #:
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| 2
|
| |
|
|
| EC
20
|
| District One Hospital
|
| Vol #:
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| 2
|
| |
|
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| EC
21
|
| UC Davis Health System
|
| Vol #:
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| 2
|
| |
|
|
| EC
22
|
| Healthcare Facilities Management Society of New Je
|
| Vol #:
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| 2
|
| |
|
|
| EC
23
|
| Mary Free Bed Rehabilitation Hospital
|
| Vol #:
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| 2
|
| |
|
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| EC
24
|
| DeKalb Medical Center
|
| Vol #:
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| 2
|
| |
|
|
| EC
25
|
| St.atherine Hospital
|
| Vol #:
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| 2
|
| |
|
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| EC
26
|
| Cullman Regional Medical Center
|
| Vol #:
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| 2
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| |
|
|
| EC
27
|
| Southcoast Hospitals Group
|
| Vol #:
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| 2
|
| |
|
|
| EC
28
|
| Orange Park Medical Center
|
| Vol #:
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| 2
|
| |
|
|
| EC
29
|
| Southern Illinois Ch. for Healthcare Engineering
|
| Vol #:
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| 2
|
| |
|
|
| EC
30
|
| Albert Lea Medical Center/Mayo Health System
|
| Vol #:
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| 2
|
|
| | | | | | | | |
| |
|
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| EC
31
|
| Wabash General Hospital
|
| Vol #:
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| 2
|
| |
|
|
| EC
32
|
| Stormont-Vail HealthCare
|
| Vol #:
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| 2
|
| |
|
|
| EC
33
|
| North Philadelphia Health System
|
| Vol #:
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| 2
|
| |
|
|
| EC
34
|
| Providence Saint Joseph Medical Center
|
| Vol #:
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| 2
|
| |
|
|
| EC
35
|
| St Vincent Health System
|
| Vol #:
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| 2
|
| |
|
|
| EC
36
|
| St. Alphonsus Regional Medical Center
|
| Vol #:
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| 2
|
| |
|
|
| EC
37
|
| Crestwood Medical Center
|
| Vol #:
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| 2
|
| |
|
|
| EC
38
|
| Saint Alphonsus Regional Medical Center
|
| Vol #:
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| 2
|
| |
|
|
| EC
39
|
| Crestwood Medical Center
|
| Vol #:
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| 2
|
| |
|
|
| EC
40
|
| Portage Health System
|
| Vol #:
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| 2
|
| |
|
|
| EC
41
|
| INTEGRIS Baptist Medical Center
|
| Vol #:
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| 2
|
| |
|
|
| EC
42
|
| INTEGRIS Southwest Medical Center
|
| Vol #:
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| 2
|
| |
|
|
| EC
43
|
| Thompson Health
|
| Vol #:
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| 2
|
| |
|
|
| EC
44
|
| Elmhurst Memorial Healthcare
|
| Vol #:
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| 2
|
| |
|
|
| EC
45
|
| Univeristy of Alabama at Birmingham Hospital Maint
|
| Vol #:
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| 2
|
| |
|
|
| EC
46
|
| Pennsylvania Association of County Affiliated Home
|
| Vol #:
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| 2
|
| |
|
|
| EC
47
|
| Genesis Health System
|
| Vol #:
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| 2
|
| |
|
|
| EC
48
|
| Genesis Medical Center
|
| Vol #:
|
| 2
|
| |
|
|
| 2004D-0369
|
| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
|
| |
|
|
| EMC 1
|
| Form Letter
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 2
|
| B. Winters
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 3
|
| D. Thompson
|
| Vol #:
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| 1
|
| |
|
|
| EMC 4
|
| K. Corrigan
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
5
|
| Organics in America
|
| Vol #:
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| 1
|
| |
|
|
| EMC 6
|
| L. Pazzaglia
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 7
|
| S. Haven
|
| Vol #:
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| 1
|
| |
|
|
| EMC 8
|
| P. Buechler
|
| Vol #:
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| 1
|
| |
|
|
| EMC 9
|
| S. Muzzey
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 10
|
| S. Brown
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0431
|
| Draft Guidance for Industry: Current Good Manufacturing Practices for Combination Products
|
| |
|
|
| EMC
2
|
| Combination Product Coalition (CPC)
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
3
|
| Advanced Medical Technology Assn (AdvaMed)
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
4
|
| Medtronic Neurological
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0443
|
| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
|
| |
|
|
| EMC
3
Attachment
|
| Japan Society of Pharmaceutical Machinery and Engineering (JSPME)
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
| |
|
|
| EMC
4
|
| Merck & Co., Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EMC
5
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 2
|
| |
|
|
| EMC
6
|
| Active Pharmaceutical Ingredients Committee (APIC)
|
| Vol #:
|
| 2
|
| |
|
|
| 2004D-0453
|
| Compliance Policy Guide Sec. 560.400 - "Imported Milk and Cream Federal Import Milk Act (CPG 7119.05)"
|
| |
|
|
| EMC
4
|
| Nestle USA, Inc. (Nestle)
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 5
|
| Number not used
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0499
|
| Compliance Policy Guide Sec. 400.210 Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs
|
| |
|
|
| EMC
1
|
| Secure Sumbology, Inc. (SSI)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0543
|
| Include a Definition for Rice and Rice Wine Vinegar in the Compliance Policy Guide for Vinegar , CPG 7109.22
|
| |
|
|
| GDL
1
|
| The Vinegar Institute
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0454
|
| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
|
| |
|
|
| EMC
5
|
| ZeaVision, LLC
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0544
|
| ANDA for ondansetron hydrochloirde injection, 8mg/4mL prefilled syringes
|
| |
|
|
| ACK
1
|
| Olsson,Frank and Weeda, P.C.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Enclosure
A, B
|
| Olsson,Frank and Weeda, P.C.
|
| Vol #:
|
| 1
|
|
|
