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| Dockets Entered
On November 8, 2005
Table of Contents
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| Docket #
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| Title
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| 1976N-0052G
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| OTC general comments & combinations
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| 1995N-0205
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| OTC Bronchodilator Drug Products
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| 1995N-0294
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| Quality/fill container; common or unusual name regulations
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-0033
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| Combat the spread of transmissible spongiform encephalopathy
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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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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| 2004D-0146
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| Guidance for Industry: Validation of Analytical Procedures for Type C Medicated Feeds
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| 2005D-0334
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| Guidance for Industry on the Pediatric Research Equity Act
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| 2005D-0344
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| Ear, Nose, and Throat Devices; Tinnitus Masker; Designation of Special Controls
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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-0346
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| Ear, Nose, and Throat Devices; Tinnitus Masker; Designation of Special Controls
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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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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2005N-0404
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| Solicitation of Public Review and Comment on Research Protocol:
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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| 2005N-0419
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| Change of Name; Technical Amendment
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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-0450
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| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
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| 1976N-0052G
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| OTC general comments & combinations
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| EMC
2
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| Wyeth Consumer Healthcare (Wyeth)
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| Vol #:
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| 35
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| 1995N-0205
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| OTC Bronchodilator Drug Products
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| EMC
1
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| Wyeth Consumer Healthcare (Wyeth)
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| Vol #:
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| 7
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| 1995N-0294
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| Quality/fill container; common or unusual name regulations
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| EMC
12
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| Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 5
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| EMC 4232
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| J. Rich
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| Vol #:
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| 515
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| 1999P-0033
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| Combat the spread of transmissible spongiform encephalopathy
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| EMC 14
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| J. Seidel
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| Vol #:
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| 9
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| | | | | | | | |
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| EMC 5849
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| J. Rich
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| Vol #:
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| 789
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| EMC 118
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| G. Copeland
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| Vol #:
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| 14
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| EMC 119
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| G. Kuttesch
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| Vol #:
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| 14
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| EMC 120
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| S. Crabtree
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| Vol #:
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| 14
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| EMC 121
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| K and C Cheek
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| Vol #:
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| 14
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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 1151
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| J. Moll
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| Vol #:
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| 11
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| EMC 1152
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| No signature
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| Vol #:
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| 11
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| 2004D-0146
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| Guidance for Industry: Validation of Analytical Procedures for Type C Medicated Feeds
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| GDL
2
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| Guidance
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| Vol #:
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| 1
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|
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| NAD
2
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| FDA
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| Vol #:
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| 1
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|
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| EMC
1148
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| New Zealand Embassy
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| Vol #:
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| 15
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|
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| EMC 1149
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| A. Kingsley, MPA, PhD
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| Vol #:
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| 15
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| EMC
1150
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| Devro, Inc.
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| Vol #:
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| 15
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| EMC
1151
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| Darling International, Inc.
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| Vol #:
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| 15
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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|
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| N
4
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| FDA
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| Vol #:
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| 1
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|
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| 2005D-0334
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| Guidance for Industry on the Pediatric Research Equity Act
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|
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| EC
1
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| AstraZeneca LP
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| Vol #:
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| 1
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|
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| 2005D-0344
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| Ear, Nose, and Throat Devices; Tinnitus Masker; Designation of Special Controls
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|
|
|
|
| GDL
1
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| Guidance
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| Vol #:
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| 1
|
|
|
|
|
| 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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|
|
|
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| EMC 447
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| J. Thomas
|
| Vol #:
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| 33
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| EMC 448
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| A. Ziemba
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| Vol #:
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| 33
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|
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| EMC 449
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| V. Prongay
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| Vol #:
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| 33
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| EMC 450
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| M. Murdoch
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| Vol #:
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| 33
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| EMC 451
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| L. Larson
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| Vol #:
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| 33
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|
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| 2005N-0346
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| Ear, Nose, and Throat Devices; Tinnitus Masker; Designation of Special Controls
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| | | | | | | | |
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| NPR
1
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| FDA
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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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|
|
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| EC
5
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| Ms. Yasaman Ayat
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| Vol #:
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| 2
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|
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| EC
6
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| Commercial Alert
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| Vol #:
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| 2
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| EMC 52
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| J. Tardos
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| Vol #:
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| 2
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| EMC 53
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| S. Lundquist
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| Vol #:
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| 2
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| EMC 54
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| J. Berry
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| Vol #:
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| 2
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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|
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| EAPE 66
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| Ratto, Nick
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| Vol #:
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| 1
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| EAPE 67
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| Burkholder , Rebecca
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| Vol #:
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| 1
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| EAPE 68
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| Winckler, Susan
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| Vol #:
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| 1
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| EAPE 69
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| Day, Ruth
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| Vol #:
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| 1
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| EAPE 70
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| Dhruvakumar, Sadhana
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| Vol #:
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| 1
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| EAPE 71
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| Andrews, Elizabeth
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| Vol #:
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| 1
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| EMC
1
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| RTI Health Solutions
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| Vol #:
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| 1
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| 2005N-0404
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| Solicitation of Public Review and Comment on Research Protocol:
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| EC
4
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| Ms. Melissa Harry
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| Vol #:
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| 1
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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| EC
1
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| Dr. Iwan Darmansjah
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| Vol #:
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| 1
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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|
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| EC
1
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| Mr. Richard Rockwell
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| Vol #:
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| 1
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| 2005N-0419
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| Change of Name; Technical Amendment
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|
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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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| |
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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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| EC
152
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| Ms. Cathi Galvin
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| Vol #:
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| 3
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| EC
153
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| Sylacauga Anesthesia, P.C.
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| Vol #:
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| 3
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|
|
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| 2005P-0450
|
| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
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|
|
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| ACK
1
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| HFA-305 to Center for Science in the Public Interest
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| Vol #:
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| 1
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| CP
1
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| Center for Science in the Public Interest
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| Vol #:
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| 1
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| LET
1
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| American College of Preventive Medicine et al
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| Vol #:
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| 1
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