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| Dockets Entered On
April 10, 2006
Table of Contents
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| 1991F-0457
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| Safe use of Glycerides and Polyethylene Glycol Esters
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| 1997P-0498
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| Label foods & beverages containing greater than 5mg caffeine
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| 1998D-1218
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| Pilot program for gamma irradiated blood & blood components
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| 1998P-1121
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| Grated Parmesan Cheese Deviating from Identity standard
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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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| 2003N-0324
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| New Animal Drugs; Removal of Obsolete and Redundant Regulations
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| 2004P-0294
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| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| 2005N-0347
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| Biological Products for Treatment of Rare Plasma Protein Disorders
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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| 2005P-0095
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| ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP
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| 2006D-0044
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| Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
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| 2006D-0066
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| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| 2006D-0121
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| Guidance for Industry and Food and Drug Administration: In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path
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| 2006N-0019
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| Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
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| 2006N-0029
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Impact of Coupons on Consumer Perceptions of Products in Prescription Drugs in Direct-to-Consumer Prescription Drug Prin
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| 2006N-0036
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
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| 2006N-0109
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| General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities
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| 2006P-0060
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| ANADA for Unibute Granules 200 mg phenylbutazone per g of of granules instant of paste
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| 2006P-0101
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| Petition for Review of Codex Standard for Honey Under 21 CFR 130.6
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| 2006P-0154
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| remove from the market, the prescription version of Xenical (orlistat,Roche Pharmaceuticals)
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| 2006V-0153
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| Variance for Hair Removal System
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| 1976N-0052N
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| OTC Nasal Decongestants
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| SUP 8
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| Robinson & Cole, LLP
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| Vol #:
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| 93
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| SUP 8
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| Robinson & Cole, LLP
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| Vol #:
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| 105
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| | | | | | | | |
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| 1991F-0457
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| Safe use of Glycerides and Polyethylene Glycol Esters
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| OB 3
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| I. Harding
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| Vol #:
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| 1
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| 1997P-0498
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| Label foods & beverages containing greater than 5mg caffeine
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| EMC 6
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| B. Crum
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| Vol #:
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| 1
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| 1998D-1218
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| Pilot program for gamma irradiated blood & blood components
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| EMC 22
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| C. Chawla
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| Vol #:
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| 3
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| 1998P-1121
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| Grated Parmesan Cheese Deviating from Identity standard
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| LET 8
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| HFS-800 to Arthur Schuman, Inc.
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| Vol #:
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| 2
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| SUP 1
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| Arthur Schuman, Inc.
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| Vol #:
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| 2
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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 1317
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| R. Seath
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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 626
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 627
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 628
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 629
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 630
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 631
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| Mission Possible International
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| Vol #:
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| 9
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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 1263
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| No signature
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| Vol #:
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| 12
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| EMC 1264
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| No signature
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| Vol #:
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| 12
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| EMC 1265
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| M. Nagorny
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| Vol #:
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| 12
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| EMC 1266
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| J. Whelan
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| Vol #:
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| 12
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| EMC 1267
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| T. Fuchs
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| Vol #:
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| 12
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| EMC 1268
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| N. Wade
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| Vol #:
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| 12
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| EMC 1269
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| J. Manning
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| Vol #:
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| 12
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| EMC 1270
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| No signature
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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 300
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| Consumers for Dental Choice
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| Vol #:
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| 7
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| 2003N-0324
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| New Animal Drugs; Removal of Obsolete and Redundant Regulations
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| NFR 1
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| FDA
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| Vol #:
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| 1
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| NFR 2
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| FDA
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| Vol #:
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| 1
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| NFR 3
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| FDA
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| Vol #:
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| 1
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| 2004P-0294
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| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
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| EMC 3
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| Mission Possible International
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| Vol #:
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| 2
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| C 52
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| G. Pantalos, PhD
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| Vol #:
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| 6
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| 2005N-0347
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| Biological Products for Treatment of Rare Plasma Protein Disorders
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| C 1
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| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 1
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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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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| 2005P-0095
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| ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP
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| SUP 1
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| Luitpold Pharmaceuticals, Inc.
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| Vol #:
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| 3
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| 2006D-0044
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| Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
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| C 7
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| Stanford University
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| Vol #:
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| 1
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| C 8
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| AstraZeneca Pharmaceuticals, LP
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| Vol #:
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| 1
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| 2006D-0066
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| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| C 5
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| Liberty Richter
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| Vol #:
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| 1
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| 2006D-0121
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| Guidance for Industry and Food and Drug Administration: In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path
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| GDL 1
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| Guidance
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| Vol #:
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| 1
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| NAD 1
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| FDA
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| Vol #:
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| 1
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| 2006N-0019
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| Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
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| C 2
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| Stryker Spine
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| Vol #:
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| 1
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| 2006N-0029
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Impact of Coupons on Consumer Perceptions of Products in Prescription Drugs in Direct-to- Consumer Prescription Drug Prin
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| C 1
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| Sanofi-aventis US, Inc.
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| Vol #:
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| 1
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| 2006N-0036
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
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| C 1
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| Kellogg Company (Kellogg)
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| Vol #:
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| 1
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| 2006N-0109
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| General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities
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| BKG 1
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| Background Material
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| Vol #:
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| 2
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| 2006P-0060
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| ANADA for Unibute Granules 200 mg phenylbutazone per g of of granules instant of paste
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| PAV 1
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| HFV-100 to MacLeon Pharmaceuticals Inc.
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| Vol #:
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| 1
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| 2006P-0101
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| Petition for Review of Codex Standard for Honey Under 21 CFR 130.6
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| C 1
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| Tropical Blossom Honey Co., Inc.
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| Vol #:
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| 1
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| ACK 1
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| HFA-305 to Chemically Associated Neurological Disorders
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| Vol #:
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| 1
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| PSA 1
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| Chemically Associated Neurological Disorders
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| Vol #:
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| 1
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| 2006P-0154
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| remove from the market, the prescription version of Xenical (orlistat,Roche Pharmaceuticals)
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| CP 1
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| Public Citizen
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| Vol #:
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| 1
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| 2006V-0153
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| Variance for Hair Removal System
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| ACK 1
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| HFA-305 to Palomar Medical Technologies, Inc.
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| Vol #:
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| 1
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| VAR 1
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| Palomar Medical Technologies, Inc.
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| Vol #:
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| 1
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