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| Dockets Entered
On March 23, 2005
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999D-1458
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| Enforcement Policy for FDA Personnel/Electronic Records& Sig
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000D-1538
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| Electronic Records; Electronic Signatures, Validation
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| 2000D-1539
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| Electronic Records & Signatures, Retention of Electronic Rec
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| 2000D-1542
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| Electronic Signatures: Time Stamps
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| 2000D-1543
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| Electronic Signatures: Glossary of Terms
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| 2000N-1596
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| Uniform Compliance Date for Food Labeling Regulations
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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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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003D-0060
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| Part11, Electronic records, electronic signatures scope
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| 2003D-0167
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| Draft Guidance for Industry on Dispute Resolution Procedures for Science-based Decisions on Products Regulated by the Center for Veterinary Medicine; Availability
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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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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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2004D-0042
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| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
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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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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| 2004N-0479
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| Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability
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| 2004P-0390
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| ANDA Suitability for Doxycycline Hyclate Tablets, 75mg and 100mg
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| 2004P-0429
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| Revoke 21 C.F.R. Part 11 in its entirety, and purse implementation of electronic record and signature
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| 2004Q-0144
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| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
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| 2004Q-0201
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| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
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| 2005D-0022
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| International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals
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| 2005D-0113
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| Preclinical and Clinical Trial Design for Cervical and Lumbar Disco Replacement Systems
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| 2005N-0065
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| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
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| 2005N-0083
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| Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics
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| 2005P-0094
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| Remove the drug Iressa (gefitnib; AstraZeneca) from the market immediately
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| 2005P-0111
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| Number Not used
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| | | | | | | | |
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| EMC 99
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| T. Bowermeister
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| Vol #:
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| 143
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| EMC 100
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| M. Smith
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| Vol #:
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| 143
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| EMC 101
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| W. Arnold, Jr.
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| Vol #:
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| 143
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| EMC 102
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| No signature
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| Vol #:
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| 143
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| EMC 103
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| No signature
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| Vol #:
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| 143
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| EMC 104
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| No signature
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| Vol #:
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| 143
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| EMC 105
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| No signature
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| Vol #:
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| 143
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| EMC 106
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| No signature
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| Vol #:
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| 143
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| EMC 107
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| No signature
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| Vol #:
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| 143
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| M
737
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| Statistical Report for September 2003
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| Vol #:
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| 52
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| M
738
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| Statistical Report for October 2003
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| Vol #:
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| 52
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| M
739
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| Statistical Report for December 2003
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| Vol #:
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| 52
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4300
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| W. Weller
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| Vol #:
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| 320
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| EMC 4301
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| M. Zielonko and R. Jones
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| Vol #:
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| 320
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| 1999D-1458
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| Enforcement Policy for FDA Personnel/Electronic Records& Sig
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| EMC
1
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| Triangle PEERS
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| Vol #:
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| 1
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| EMC 4218
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| C. Craig
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| Vol #:
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| 515
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 588
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| No signature
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| Vol #:
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| 24
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| EMC 589
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| No signature
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| Vol #:
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| 24
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| EMC 590
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| C. Schiffert, MD
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| Vol #:
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| 24
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| EMC
591
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| EHN
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| Vol #:
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| 24
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| EMC 592
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| C. Pitts
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| Vol #:
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| 24
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| 2000D-1538
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| Electronic Records; Electronic Signatures, Validation
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| EMC
6
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| Triangle PEERS
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| Vol #:
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| 9
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| 2000D-1539
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| Electronic Records & Signatures, Retention of Electronic Rec
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| EMC
17
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| Triangle PEERS
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| Vol #:
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| 9
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| 2000D-1542
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| Electronic Signatures: Time Stamps
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| EMC
6
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| Triangle PEERS
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| Vol #:
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| 7
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| EMC 14359
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| D. Purcell
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| Vol #:
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| 342
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| EMC 14360
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| E. Coe
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| Vol #:
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| 342
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| EMC 14361
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| E. Dunham
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| Vol #:
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| 342
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| EMC 14362
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| L. Baldwin
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| Vol #:
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| 342
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| EMC 14363
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| L. Baldwin
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| Vol #:
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| 342
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| EMC 14364
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| B. Hanson
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| Vol #:
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| 342
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| EMC 14365
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| J. Young
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| Vol #:
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| 342
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| EMC 14366
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| B. Bryant
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| Vol #:
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| 342
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| EMC 14367
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| K. Fillare
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| Vol #:
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| 342
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| EMC 14368
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| K. Fillare
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| Vol #:
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| 342
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| EMC 14369
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| S. Haughney
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| Vol #:
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| 342
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| EMC 14370
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| S. Griffin
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| Vol #:
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| 342
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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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| EMC 1257
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| C. Welsh
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| Vol #:
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| 5
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| EMC 1258
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| No signature
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| Vol #:
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| 5
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 210
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| M. Adams
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| Vol #:
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| 4
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 442
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| Mission Possible International
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| Vol #:
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| 7
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| EMC
443
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| Calorie Control Council
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| Vol #:
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| 7
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| 2003D-0060
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| Part11, Electronic records, electronic signatures scope
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| EMC
19
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| Triangle PEERS
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| Vol #:
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| 3
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| 2003D-0167
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| Draft Guidance for Industry on Dispute Resolution Procedures for Science-based Decisions on Products Regulated by the Center for Veterinary Medicine; Availability
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| EMC 1
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| B. Sachau
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| Vol #:
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| 1
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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| EMC 423
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| B. Clark
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| Vol #:
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| 4
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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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| EMC 689
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| H. Piserchia
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| Vol #:
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| 9
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| EMC 690
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| T. Webster
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| Vol #:
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| 9
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| EMC 691
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| S. Weber
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| Vol #:
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| 9
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| EMC 692
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| J. Hamer
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| Vol #:
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| 9
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| EMC 693
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| No signature
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| Vol #:
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| 9
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| | | | | | | | |
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| EMC 1545
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| M. Kaplan
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| Vol #:
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| 22
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| EMC 1546
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| B. Kapke
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| Vol #:
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| 22
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| EMC 1547
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| J. Cook
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| Vol #:
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| 22
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| EMC 1548
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| M. Kroopkin
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| Vol #:
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| 22
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| EMC 1549
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| M. Friedman
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| Vol #:
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| 22
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| EMC 1550
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| E. Ortiz
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| Vol #:
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| 22
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| EMC 1551
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| J. Winn
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| Vol #:
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| 22
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| EMC 1552
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| C. Toomer
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| Vol #:
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| 22
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| EMC 1553
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| R. Johnson, PhD
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| Vol #:
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| 22
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| EMC 1554
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| L. Beggs
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| Vol #:
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| 22
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| EMC 1555
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| L. Mullin
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| Vol #:
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| 22
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| EMC 1556
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| E. Sprague
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| Vol #:
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| 22
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| EMC 1557
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| A. Jones
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| Vol #:
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| 22
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| EMC 1558
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| A. Lee
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| Vol #:
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| 22
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| EMC 1559
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| C. Dobelbower
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| Vol #:
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| 22
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| EMC 1560
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| C. Toner
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| Vol #:
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| 22
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| EMC 1561
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| J. Terry
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| Vol #:
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| 22
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| EMC 1562
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| D. Perry
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| Vol #:
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| 22
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| EMC 1563
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| J. James
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| Vol #:
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| 22
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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|
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| EMC
8
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 5
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| 2004N-0479
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| Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability
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| C
8
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| Holmes Foods, Inc.
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| Vol #:
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| 1
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| 2004P-0390
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| ANDA Suitability for Doxycycline Hyclate Tablets, 75mg and 100mg
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| C
1
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| Warner Chilcott
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| Vol #:
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| 2
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| 2004P-0429
|
| Revoke 21 C.F.R. Part 11 in its entirety, and purse implementation of electronic record and signature
|
|
|
|
|
| LET
1
|
| HFD-005 to Industry Coalition
|
| Vol #:
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| 1
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| 2004Q-0144
|
| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
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| EMC
3
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| Emord & Associates, P.C.
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| Vol #:
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| 11
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| 2004Q-0201
|
| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
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| EMC
1
Attachment
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| Emord & Associates PC
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| Vol #:
|
| 16
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| REF
1
Enclosure
|
| HFS-830
|
| Vol #:
|
| 16
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|
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|
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| 2005D-0022
|
| International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals
|
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