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| Dockets Entered
On August 24, 2006
Table of Contents
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| Docket #
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| Title
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| 1978N-0064
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| OTC Antiperspirant
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| 1978P-0173
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| LASERIUM CONCERT SYSTEM
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| 2001N-0067
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| Reclassification of Dental Mercury
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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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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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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-0169
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| Dental Amalgam; Request for Information
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| 2006D-0191
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| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
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| 2006N-0067
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| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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| 2006N-0292
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| Unique Device Identification
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| 2006N-0326
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| 2006P-0092
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| Determine that Astra Zeneca's Diprivan,Teva Sicor's Propofol Injectable Emulsion, and Bedford Laboratories Propofol Injectable Emulsion are misbranded
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| 2006P-0158
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| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| 2006P-0334
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| Reclassification Petition fo Bone Heterografts
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| 2006P-0348
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| Amend the vancomycin HCl package insert to reflect modifications of the antimicrobial susceptibility interpretive criteria to better recognize emerging resistance resulting in compromised patient outc
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| 1978N-0064
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| OTC Antiperspirant
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| ANS 5
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| FDA/CDER to Beiersdorf
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| Vol #:
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| 53
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| LET 24
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| Beiersdorf
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| Vol #:
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| 53
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| 1978P-0173
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| LASERIUM CONCERT SYSTEM
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| EXP 9
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| Laserium Laser Images, Inc. (LASERIUM)
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| Vol #:
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| 1
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| 2001N-0067
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| Reclassification of Dental Mercury
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| EMC 661
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| Consumers for Dental Choice
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| Vol #:
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| 17
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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 1328
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| A. Becerra
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| Vol #:
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| 6
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 688
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| Mission Possible International
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| Vol #:
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| 10
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| EMC 689
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| Mission Possible International
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| Vol #:
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| 10
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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 1337
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| K. Keenan
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| Vol #:
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| 12
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| 2003N-0169
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| Dental Amalgam; Request for Information
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| EMC 301
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| M. Newell
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| Vol #:
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| 7
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| EMC 15
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| International Dairy Foods Association (IDFA)
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| Vol #:
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| 11
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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| C 44
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| Tap Resources
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| Vol #:
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| 3
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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| SUP 16
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| Department of the Planet Earth
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| Vol #:
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| 5
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 18068
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| M. Galindo
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| Vol #:
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| 194
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| C 18069
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| M. Ater
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| Vol #:
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| 194
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| C 18070
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| K. Taylor
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| Vol #:
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| 194
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| C 18071
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| C. Glass
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| Vol #:
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| 194
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| EMC 3729
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| D. Schilling
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| Vol #:
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| 195
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| EMC 3730
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| P. Trembley
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| Vol #:
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| 195
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| EMC 3731
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| J. Ramirez
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| Vol #:
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| 195
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| EMC 3732
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| S. Roach
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| Vol #:
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| 195
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| EMC 3733
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| D. Roemisch
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| Vol #:
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| 195
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| EMC 3734
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| S. Hanes
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| Vol #:
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| 195
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| EMC 3735
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| R. Okaty
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| Vol #:
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| 195
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| EMC 3736
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| B. Sitton
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| Vol #:
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| 195
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| EMC 3737
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| M. Welsch
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| Vol #:
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| 195
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| EMC 3738
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| M. Neumann
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| Vol #:
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| 195
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| EMC 3739
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| G. Schaefer
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| Vol #:
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| 195
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| EMC 3740
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| K. Noel
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| Vol #:
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| 195
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| EMC 3741
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| E. Schaefer
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| Vol #:
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| 195
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| EMC 3742
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| M. Grashow
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| Vol #:
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| 195
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| EMC 3743
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| N. WIlliams
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| Vol #:
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| 195
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| EMC 3744
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| C. Dunlap
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| Vol #:
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| 195
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| | | | | | | | |
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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| C 9
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| Texas Tech University
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| Vol #:
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| 2
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| 2006D-0191
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| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
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| C 6
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| Cool Group Inc. (COOK)
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| Vol #:
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| 1
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| 2006N-0067
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| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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| EXT 1
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| B. Sachau
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| Vol #:
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| 1
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| 2006N-0292
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| Unique Device Identification
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| EC 14
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| Meridian Health
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| Vol #:
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| 1
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| 2006N-0326
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| LET 2
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| FDA/CDER to Public Citizen's Health Research Group
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| Vol #:
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| 1
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| 2006P-0092
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| Determine that Astra Zeneca's Diprivan,Teva Sicor's Propofol Injectable Emulsion, and Bedford Laboratories Propofol Injectable Emulsion are misbranded
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| LET 1
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| FDA/CDER to Amphastar Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2006P-0158
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| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
|
|
|
|
|
| EMC 36
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| Mission Possible International
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| Vol #:
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| 1
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| EC 134
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| Archdiocese of New York
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| Vol #:
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| 3
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| EC 135
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| Mr. Richard Brand
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| Vol #:
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| 3
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| EC 136
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| advocates of life
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| Vol #:
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| 3
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| EC 137
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| Ms. Kathleen Muro
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| Vol #:
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| 3
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| EC 138
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| Mr. Gregory Jenkins
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| Vol #:
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| 3
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| EC 139
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| Mr. Walter, Jr. Bonnell
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| Vol #:
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| 3
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| EMC 36
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| G. Lodholz
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| Vol #:
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| 2
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| 2006P-0334
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| Reclassification Petition fo Bone Heterografts
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| 2006P-0348
|
| Amend the vancomycin HCl package insert to reflect modifications of the antimicrobial susceptibility interpretive criteria to better recognize emerging resistance resulting in compromised patient outc
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| ACK 1
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| FDA/DDM to Clinical and Laboratory Standards Institute
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| Vol #:
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| 1
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