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| Dockets Entered
On August 27, 2004
Table of Contents
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| Docket #
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| Title
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| 1990N-0165
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| Serving Sizes Food Labeling
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2003D-0229
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2004D-0193
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| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
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| 2004N-0018
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| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004N-0184
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| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
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| 2004N-0194
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| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
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| 2004N-0254
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| Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children
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| 2004N-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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| 2004P-0202
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| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
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| 2004S-0212
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| Pandemic Influenza Preparedness and Response Plan
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| 2004S-0233
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| Stimulating Innovation in Medical Technologies
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| 2004V-0380
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| Laser Light Show
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| 1990N-0165
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| Serving Sizes Food Labeling
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| BKG 1
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| Background Material
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| Vol #:
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| 29
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
14478
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| BioZak
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| Vol #:
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| 126
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| LET
14479
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| Inverness Medical Nutritionals Group
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| Vol #:
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| 126
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| LET
14480
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| Perrigo Company of South Carolina
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| Vol #:
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| 126
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| LET
14481
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| Perrigo Company of South Carolina
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| Vol #:
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| 126
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| LET
14482
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| Perrigo Company of South Carolina
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| Vol #:
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| 126
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| LET
14483
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| Enzymatic Therapy
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| Vol #:
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| 126
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| LET
14484
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| Enzymatic Therapy
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| Vol #:
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| 126
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| LET
14485
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| Vital Nutrients
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| Vol #:
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| 126
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| LET
14486
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| BioZak, Inc.
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| Vol #:
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| 126
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| LET
14487
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| Perrigo Company of South Carolina
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| Vol #:
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| 126
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| LET
14488
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| Enzymatic Therapy
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| Vol #:
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| 126
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| LET
14489
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| Enzymatic Therapy
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| Vol #:
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| 126
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| LET
14490
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| Enzymatic Therapy
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| Vol #:
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| 126
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| LET
14491
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| Enzymatic Therapy
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| Vol #:
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| 126
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| LET
14492
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| Enzymatic Therapy
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| Vol #:
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| 126
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| LET
14493
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| Enzymatic Therapy
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| Vol #:
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| 126
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| LET
14494
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| Enzymatic Therapy
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| Vol #:
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| 126
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| LET
14495
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| Enzymatic Therapy
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| Vol #:
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| 126
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| LET
14496
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| Perrigo Company of South Carolina
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| Vol #:
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| 126
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| LET
14497
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| Perrigo Company of South Carolina
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| Vol #:
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| 126
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| LET
14498
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| Perrigo Company of South Carolina
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| Vol #:
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| 126
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| LET
14499
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| Perrigo Company of South Carolina
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| Vol #:
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| 126
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| LET
14500
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| Perrigo Company of South Carolina
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| Vol #:
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| 126
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| LET
14501
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| Perrigo Company of South Carolina
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| Vol #:
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| 126
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| LET
14502
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| Perrigo Company of South Carolina
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| Vol #:
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| 126
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| LET
14503
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| Perrigo Company of South Carolina
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| Vol #:
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| 126
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| LET
14504
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| Spirit Sciences USA, Inc.
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| Vol #:
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| 126
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| LET
14505
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| Bausch & Lomb Incorporated
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| Vol #:
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| 126
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| EMC 794
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| C. Schau
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| Vol #:
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| 33
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| EMC 201
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| Linda
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| Vol #:
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| 3
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| EMC 202
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| No signature
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| Vol #:
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| 3
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| EMC 203
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| B. Scott
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| Vol #:
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| 3
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| EMC 204
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| J. Yamrick
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| Vol #:
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| 3
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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|
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| EXB 501
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| Center for Veterinary Medicine
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| Vol #:
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| 432
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| EXB 502
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| Center for Veterinary Medicine
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| Vol #:
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| 432
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| EXB 503
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| Center for Veterinary Medicine
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| Vol #:
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| 432
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| EXB 504
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| Center for Veterinary Medicine
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| Vol #:
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| 432
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| EXB 505
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| Center for Veterinary Medicine
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| Vol #:
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| 432
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|
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| SF
8
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| GCF-1
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| Vol #:
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| 444
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
| | | | | | | | |
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| EMC 10255
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| V. Loro
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| Vol #:
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| 287
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| EMC 10256
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| J. Cave
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| Vol #:
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| 287
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| EMC 10257
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| N. Gronlund
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| Vol #:
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| 287
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| EMC 10258
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| R. Sachais
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| Vol #:
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| 287
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| EMC 10259
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| R. Pattillo
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| Vol #:
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| 287
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| EMC 10260
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| K. Shaw
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| Vol #:
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| 287
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| EMC 10261
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| S. Paisley
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| Vol #:
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| 287
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| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
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|
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| EMC 1244
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| S. Miller
|
| Vol #:
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| 5
|
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|
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
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| EMC 184
|
| D. Elliott
|
| Vol #:
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| 3
|
|
|
|
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| 2003D-0229
|
| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
|
|
|
|
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| EMC 1
|
| B. Sachau
|
| Vol #:
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| 1
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|
|
|
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| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
|
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| RFF
2
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| Korangy Radiology Associates, P.A.
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| Vol #:
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| 4
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| RFF
3
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| GCF-1
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| Vol #:
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| 4
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| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
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| EMC 349
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| J. Heffington
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| Vol #:
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| 8
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| EMC 350
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| M. Marshall
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| Vol #:
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| 8
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| EMC 351
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| D. Toutin
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| Vol #:
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| 8
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| EMC 352
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| D. Toutin
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| Vol #:
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| 8
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| EMC 353
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| D. Bryant
|
| Vol #:
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| 8
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| EMC 354
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| K. Skinner
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| Vol #:
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| 8
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| EMC 355
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| T. Hurren
|
| Vol #:
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| 8
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| EMC 356
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| J. Rogers, MS
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| Vol #:
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| 8
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| EMC 357
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| J. Wickham
|
| Vol #:
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| 8
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| EMC 358
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| J. Cartee
|
| Vol #:
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| 8
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|
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|
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| EMC 359
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| J. Tillett
|
| Vol #:
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| 8
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|
|
|
|
| 2003P-0029
|
| Remove metered-dose inhalers (MDI) containing moiety albuter
|
|
|
|
|
| EMC
39
|
| 3M Company (3M)
|
| Vol #:
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| 5
|
|
|
|
|
| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
|
|
|
|
|
| EMC 268
|
| S. Bishop
|
| Vol #:
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| 5
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| | | | | | | | |
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| EMC 269
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| D. Bishop
|
| Vol #:
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| 5
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| EMC 270
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| D. Matula
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| Vol #:
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| 5
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| EMC 271
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| J. Bishop
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| Vol #:
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| 5
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| EMC 272
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| L. and T McAnaugh
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| Vol #:
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| 5
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| EMC 273
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| A. Barnett
|
| Vol #:
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| 5
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| EMC
274
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| Eye Bank Assn of America (EBAA)
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| Vol #:
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| 5
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| EMC 275
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| C. Handy
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| Vol #:
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| 5
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| EMC 276
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| J. Holbrook
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| Vol #:
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| 5
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| EMC 277
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| V. Snyder, MSW
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| Vol #:
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| 5
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| EMC 278
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| J. Maes
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| Vol #:
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| 5
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| EMC
279
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| Cord Blood Registry (CBR)
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| Vol #:
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| 5
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| EMC 280
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| E. Hazen
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| Vol #:
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| 5
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| EMC 281
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| T. Bernett
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| Vol #:
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| 5
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| EMC 282
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| I. Ruiz
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| Vol #:
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| 5
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| EMC 283
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| S. Landes
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| Vol #:
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| 5
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| EMC 284
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| Y. Cruz
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| Vol #:
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| 5
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| EMC 285
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| L. Parnell
|
| Vol #:
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| 5
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| EMC 286
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| B. Dilos
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| Vol #:
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| 5
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|
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|
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| EMC 287
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| L. Samuels
|
| Vol #:
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| 5
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|
|
|
|
| 2004N-0018
|
| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
|
|
|
|
|
| EMC 2
|
| L. Grenade,MD,MPH
|
| Vol #:
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| 1
|
|
|
|
|
| 2004N-0081
|
| BSE Risk Materials in Foods and Cosmetics
|
|
|
|
|
| EMC
6
|
| Australian Government
|
| Vol #:
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| 1
|
|
|
|
|
| EMC
7
|
| Australian Government
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0184
|
| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
|
|
|
|
|
| EMC
11
|
| National Coalition of Food Importing Associations (NCFIA or the Coalition)
|
| Vol #:
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| 2
|
|
|
|
|
| EMC
12
|
| National Coalition of Food Importing Associations (NCFIA or the Coalition)
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004N-0194
|
| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
|
|
|
|
|
| EMC
3
|
| Smith & Nephew wound Management
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 4
|
| D. Bing
|
| Vol #:
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| 1
|
|
|
|
|
| EMC
5
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
6
|
| Eli Lilly and Company
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
7
|
| Cambrex BioScience Walkersville, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0254
|
| Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children
|
|
| | | | | | | | |
|
|
|
|
| EMC 6
|
| G. Tibbs
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0257
|
| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
|
|
|
|
|
| EMC
16
|
| Australian Government
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
17
|
| Australian Government
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
18
|
| Southamerican Gelatine Manufacturers Assn (SAGMA)
|
| Vol #:
|
| 3
|
|
|
|
|
| 2004P-0202
|
| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
|
|
|
|
|
| EMC 6
|
| W. Peterson
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004S-0212
|
| Pandemic Influenza Preparedness and Response Plan
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004S-0233
|
| Stimulating Innovation in Medical Technologies
|
|
|
|
|
| EMC
1
|
| Washington Legal Foundation (WLF)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
2
|
| Plasma Protein Therapeutics Assn (PPTA)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
3
|
| Plasma Protein Therapeutics Assn (PPTA)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
4
|
| Merck & Co., Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004V-0380
|
| Laser Light Show
|
|
|
|
|
| ACK 1
|
| HFA-305 to Delta Marine
|
| Vol #:
|
| 1
|
|
|
|
|
| VAR
1
|
| Delta Marine
|
| Vol #:
|
| 1
|
|
