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| Dockets Entered
On September 21, 2005
Table of Contents
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| Docket #
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| Title
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 2000V-1410
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| Class IIIb requirements for the IZLID Series laser Products
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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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-0018
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| Race and Ethnicity Data in Clinical Trials for FDA
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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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| 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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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004Q-0083
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| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 2005D-0386
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| Most frequently questions about analyte specific reagents; Industry Proposal
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005N-0120
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| 2005N-0143
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| High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005N-0349
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| FDA Survey of Current Manufacturing Practices in the Food Industry
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005P-0116
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| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| 2005P-0305
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| Remove Dietary Supplements that Contain the Drug Pyridoxamine
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| 2005P-0325
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| Request Commissioner of Food and Drugs to amend its regulations related to sugar and alternative sweeteners
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| SUP
44
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| Northfield Laboratories BB IND #10719
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| Vol #:
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| 48
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| 2000V-1410
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| Class IIIb requirements for the IZLID Series laser Products
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| EXP 1
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| B E Myers & Co Inc, Extro Optics
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| Vol #:
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| 1
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| EC
1
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| Ammirati Regulatory Consulting
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| Vol #:
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| 3
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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 1284
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| D Piatek
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| Vol #:
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| 6
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| EMC 1285
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| E Moller
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| Vol #:
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| 6
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| 2002D-0018
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| Race and Ethnicity Data in Clinical Trials for FDA
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| EMC 5
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| B Sachau
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| Vol #:
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| 2
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 227
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| C Q Carter
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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 524
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| B Martini
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| Vol #:
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| 8
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| EMC 525
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| B Martini
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| Vol #:
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| 8
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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 1117
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| S Berson
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| Vol #:
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| 11
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| EMC 1118
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| C Williams
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| Vol #:
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| 11
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| EMC 1119
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| T Burnett
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| Vol #:
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| 11
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| EMC 1145
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| T S Singleton
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| Vol #:
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| 15
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| 2004Q-0083
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| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
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| LET
17
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| HFS-800 to Fleminger Inc
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| Vol #:
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| 8
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| EMC 350
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| A Croissant
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| Vol #:
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| 9
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| 2005D-0386
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| Most frequently questions about analyte specific reagents; Industry Proposal
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| GDL
1
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| Advanced Medical Technology Association
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| Vol #:
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| 1
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| MO 2
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| GCF-1
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| Vol #:
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| 1
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| 2005N-0120
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| EMC
2
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| Kraft Foods Global Inc
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| Vol #:
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| 1
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| EMC
3
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| Kraft Foods
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| Vol #:
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| 1
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| EC 49
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| advanced thyroid cancer survivor
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| Vol #:
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| 1
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| EC 50
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| Mrs. Nancy Long
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| Vol #:
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| 1
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| EC 51
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| Ms. Barbara Statas
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| Vol #:
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| 1
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| EMC 2
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| D Berger
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| Vol #:
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| 1
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| 2005N-0143
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| High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing
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| C 613
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| H J Naden
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| Vol #:
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| 21
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| C 614
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| M Kramer
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| Vol #:
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| 21
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| C 615
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| C Roberts
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| Vol #:
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| 21
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| C 616
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| E & P K Lerer
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| Vol #:
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| 21
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| C 617
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| J Arlian
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| Vol #:
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| 21
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| C 618
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| No Submitter
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| Vol #:
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| 21
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| C 619
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| D A Martin
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| Vol #:
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| 21
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| EC
1516
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| Mr. Ray Roop
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| Vol #:
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| 18
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| EMC 275
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| M Burkwall
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| Vol #:
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| 5
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| EMC 276
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| C Salvati
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| Vol #:
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| 5
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| EMC 277
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| P Petrin
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| Vol #:
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| 5
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| EMC 278
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| B K Strudwick
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| Vol #:
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| 5
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| EMC 279
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| C Weed
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| Vol #:
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| 5
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| EMC 280
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| J Pruitt
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| Vol #:
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| 5
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| EMC 281
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| J Lugg
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| Vol #:
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| 5
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| C 7
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| K Waserman
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| Vol #:
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| 1
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| C 8
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| Form Letter count 15
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| Vol #:
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| 5
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| C 9
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| J Nichols
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| Vol #:
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| 1
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| C 10
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| M Merkal
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| Vol #:
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| 1
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| EC
436
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| Professional Medical Services
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| Vol #:
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| 2
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| EC
437
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| Families for Life
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| Vol #:
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| 2
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| EC 438
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| Mrs. Ruth Ann Carter
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| Vol #:
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| 2
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| EC 439
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| Ms. Dorothy Wells
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| Vol #:
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| 2
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| EC 440
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| Mr. Russell Engbrecht
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| Vol #:
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| 2
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| EMC
164
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| Juridic Embassy, Micro ICU Project
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| Vol #:
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| 3
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| EMC 165
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| A Benson
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| Vol #:
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| 3
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| 2005N-0349
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| FDA Survey of Current Manufacturing Practices in the Food Industry
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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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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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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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| 2005P-0116
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| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
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| LET
1
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| HFD-5 to Venable LLP
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| Vol #:
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| 2
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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