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| Dockets Entered
On July 15, 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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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| 1999F-5522
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| Ionizing radiation /control of Food-borne pathogens safe use
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| 2000N-1596
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| Uniform Compliance Date for Food Labeling Regulations
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| 2001E-0032
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| Patent Extension for VISUDYNE, No. 5,095,030
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| 2002E-0097
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| Patent Term Application for Clarinex
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| 2002E-0340
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| Antagon, U.S. Patent No. 4,801,577
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| 2003E-0260
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| Patent Extension for Amevive (alefacept), 5,547,853
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| 2004D-0118
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| International Conference on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
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| 2004E-0023
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| Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate )
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| 2004N-0279
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| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
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| 2004N-0382
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| Food Labeling: Safe Handling Statements: Labeling of Shell Eggs
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| 2004N-0539
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| Establishing a Docket for the Development of Plasma Standards Public Workshop; Availability
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| 2004P-0223
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| Whole Grain Descriptive Claims
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| 2004P-0294
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| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
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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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| |
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| 2005D-0106
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| Guidance for Industry on Systemic Lupus Erythematosus Developing Drugs for Treatment
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| |
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| 2005D-0133
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| Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
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| 2005D-0174
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| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
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| 2005D-0219
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| Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
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| 2005E-0249
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| Patent Term Extension Application for Enablex, U.S. Patent No. 5,096,890
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| 2005E-0251
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| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-506), U.S. Patent No. 5,376,634
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| 2005E-0252
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| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-754), U.S. Patent No. 5,376,634
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| 2005E-0253
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| Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498
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| 2005E-0259
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| Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
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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-0098
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| Food and Drug Administration/Drug Information Association Cross Labeling Workshop: Combination Products and Mutually Conforming Labeling
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| |
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| 2005N-0147
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| Sprout Safety Public Meeting
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| 2005N-0157
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| Agency Information Collection Activities: Proposed Collection; Postmarketing Adverse Drug Experience Reporting
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| 2005N-0190
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Export of FDA Regulated Products Export Certificates
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| 2005N-0231
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| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
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| 2005N-0262
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| ubmission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| |
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| 2005V-0260
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| Laser Light Show
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| 1976N-0052G
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| OTC general comments & combinations
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| BKG 3
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| Refs 1 - 11 found in 70FR40232
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| Vol #:
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| 37
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| NPR
5
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| FDA
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| Vol #:
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| 37
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| 1995N-0205
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| OTC Bronchodilator Drug Products
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| BKG 1
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| Refs 1 - 30 found in 70FR40237
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| Vol #:
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| 8
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| NPR
2
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| FDA
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| Vol #:
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| 8
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| EC
382
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| International Food Additives Council
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| Vol #:
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| 9
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| EC
383
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| Calorie Control Council
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| Vol #:
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| 9
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| EC
384
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| The Food Allergy
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| Vol #:
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| 9
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| EC 385
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| Dr. Mark Davis
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| Vol #:
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| 9
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| 1999F-5522
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| Ionizing radiation /control of Food-borne pathogens safe use
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| C 97
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| consumer
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| Vol #:
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| 6
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| 2000N-1596
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| Uniform Compliance Date for Food Labeling Regulations
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| EREG 1
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| Shawn Wagner
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| Vol #:
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| 1
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| 2001E-0032
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| Patent Extension for VISUDYNE, No. 5,095,030
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| |
|
|
| LET
4
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| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
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|
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| 2002E-0097
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| Patent Term Application for Clarinex
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| |
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| LET
2
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| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
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|
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| 2002E-0340
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| Antagon, U.S. Patent No. 4,801,577
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| LET
4
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| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
|
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| 2003E-0260
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| Patent Extension for Amevive (alefacept), 5,547,853
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| LET
4
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| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
|
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| 2004D-0118
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| International Conference on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
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| EC 3
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| Mr. Richard Brodie
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| Vol #:
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| 1
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| EC 4
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| Mrs. Barb Forbish
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| Vol #:
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| 1
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| 2004E-0023
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| Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate )
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| LET
5
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| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2004N-0279
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| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
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| EC
1
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| GlaxoSmithKline
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| Vol #:
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| 1
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| EC
2
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| Hoffmann-La Roche, Inc.
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| Vol #:
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| 1
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| 2004N-0382
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| Food Labeling: Safe Handling Statements: Labeling of Shell Eggs
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| EC
3
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| ILdI Inc.
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| Vol #:
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| 1
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| EC
3
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| Xceleron Ltd
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| Vol #:
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| 2
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| EC
4
Attachment
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| University of Southern California
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| Vol #:
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| 2
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| 2004N-0539
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| Establishing a Docket for the Development of Plasma Standards Public Workshop; Availability
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| |
|
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| EC
2
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| AABB
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| Vol #:
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| 1
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| EC
3
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| AABB
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| Vol #:
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| 1
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| EC
4
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| European Medicines Agency
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| Vol #:
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| 1
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| EC
5
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| European Medicines Agency (EMEA)
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| Vol #:
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| 1
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| EC
6
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| America's Blood Centers
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| Vol #:
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| 1
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| 2004P-0223
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| Whole Grain Descriptive Claims
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| C
20
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| PennState, Department of Nutritional Sciences
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| Vol #:
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| 5
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| C
21
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| Foundation for the Advancement of Grain Based Foods
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| Vol #:
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| 5
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| 2004P-0294
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| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
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|
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| EC
2
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| Calorie Control Council
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| Vol #:
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| 2
|
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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
16
Attachment
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| Fleminger, Inc
|
| Vol #:
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| 8
|
| |
|
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| 2005D-0106
|
| Guidance for Industry on Systemic Lupus Erythematosus Developing Drugs for Treatment
|
| |
|
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| C
3
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| Lupus Foundaiton of America Inc
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| Vol #:
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| 1
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| EC
1
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| GlaxoSmithKline
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| Vol #:
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| 1
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| EC
2
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| Hoffmann- La Roche, Inc.
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| Vol #:
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| 1
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| EC
3
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| Lupus Research Institute
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| Vol #:
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| 1
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| |
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| EC
4
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| Lupus Foundation of America, Inc.
|
| Vol #:
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| 1
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| |
|
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| EC
5
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| Centocor
|
| Vol #:
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| 1
|
| |
|
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| 2005D-0122
|
| Guidance for Industry on Exploratory IND Studies
|
| |
|
|
| EC
2
|
| EFPIA
|
| Vol #:
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| 1
|
| |
|
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| EC
3
|
| Xceleron Ltd
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| Vol #:
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| 1
|
| |
|
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| EC
4
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| Xceleron Ltd
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| Vol #:
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| 1
|
| |
|
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| EC
5
|
| Johnson
|
| Vol #:
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| 1
|
| |
|
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| EC
6
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| Hoffmann-La Roche, Inc.
|
| Vol #:
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| 1
|
|
| | | | | | | | |
| |
|
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| EC
7
|
| JAPANESE PHARMACEUTCAL MANUFACTURERS ASSOCIATION
|
| Vol #:
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| 1
|
| |
|
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| EC
8
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| Schering-Plough
|
| Vol #:
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| 1
|
| |
|
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| EC 9
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| Dr. John Coupal
|
| Vol #:
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| 1
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| |
|
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| EC
10
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| Regulatory Affairs Branch, CTEP, NCI
|
| Vol #:
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| 1
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| |
|
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| EC
11
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| David Geffen School of Medicine at UCLA
|
| Vol #:
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| 1
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| |
|
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| EC
12
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| Novartis Pharmaceuticals Corporation
|
| Vol #:
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| 1
|
| |
|
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| EC 13
|
| Dr. Michelle Tallin
|
| Vol #:
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| 1
|
| |
|
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| EC
14
|
| Organichem Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| EC 15
|
| Dr. Joseph Hung
|
| Vol #:
|
| 1
|
| |
|
|
| EC
16
|
| Amgen
|
| Vol #:
|
| 1
|
| |
|
|
| EC
17
|
| Mayo Clinic
|
| Vol #:
|
| 1
|
|
| |
|
| 2005D-0133
|
| Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
|
| |
|
|
| NCR
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005D-0174
|
| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
|
| |
|
|
| EC
4
|
| WakeMed
|
| Vol #:
|
| 1
|
| |
|
|
| EC 5
|
| Ms. Russell Yandon
|
| Vol #:
|
| 1
|
| |
|
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| 2005D-0219
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| Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
|
| |
|
|
| EC 1
|
| Mrs. Stephanie Barney
|
| Vol #:
|
| 1
|
| |
|
|
| 2005E-0249
|
| Patent Term Extension Application for Enablex, U.S. Patent No. 5,096,890
|
| |
|
|
| LET
2
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2005E-0251
|
| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-506), U.S. Patent No. 5,376,634
|
| |
|
|
| LET
2
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
| |
|
| 2005E-0252
|
| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-754), U.S. Patent No. 5,376,634
|
| |
|
|
| LET
2
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2005E-0253
|
| Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498
|
| |
|
|
| LET
2
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2005E-0259
|
| Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
|
| |
|
|
| LET
2
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0065
|
| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
|
| |
|
|
| EC 4
|
| National Fisheries Institue
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0098
|
| Food and Drug Administration/Drug Information Association Cross Labeling Workshop: Combination Products and Mutually Conforming Labeling
|
|
| | | | | | | | |
| |
|
|
| EC
2
|
| Combination Product Coalition
|
| Vol #:
|
| 1
|
| |
|
|
| EC
3
|
| Eli Lilly and Company
|
| Vol #:
|
| 1
|
| |
|
|
| EC
4
|
| AdvaMed
|
| Vol #:
|
| 1
|
| |
|
|
| EC
5
|
| AdvaMed
|
| Vol #:
|
| 1
|
| |
|
|
| EC
6
|
| AdvaMed
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0147
|
| Sprout Safety Public Meeting
|
| |
|
|
| EC
1
|
| Hydros Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC
2
|
| International Sprout Growers Association
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0157
|
| Agency Information Collection Activities: Proposed Collection; Postmarketing Adverse Drug Experience Reporting
|
| |
|
|
| EC
1
|
| Pharm Res
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0190
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Export of FDA Regulated Products Export Certificates
|
| |
|
|
| EC
1
|
| Block Imaging International
|
| Vol #:
|
| 1
|
| |
|
|
| EC
2
|
| Bio-Tek Instruments, Inc
|
| Vol #:
|
| 1
|
|
| |
|
| 2005N-0231
|
| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
|
|
|
|
|
|
|
| |
|
|
| EC
2
|
| USDA-ARS-WRRC
|
| Vol #:
|
| 1
|
| |
|
|
| EC
3
|
| Food Products Association
|
| Vol #:
|
| 1
|
|
| |
|
| 2005N-0262
|
| ubmission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2005V-0260
|
| Laser Light Show
|
| |
|
|
| CR
1
Attachment
|
| Fisher Theatrical
|
| Vol #:
|
| 1
|
|
|
