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| Dockets Entered
On January 14, 2005
Table of Contents
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| Docket #
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| Title
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| 2000N-1409
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| Revision of the Identification of the Ionotophoresis
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004D-0440
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| Guidance for Industry on Computerized Systems Used in Clinical Trials
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| 2004D-0460
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| Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization
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| 2004D-0466
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| Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act
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| 2004D-0510
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| Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
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| 2004D-0549
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| Guidance for Industry on Labeling OTC Human
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| 2004F-0546
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| FAP 2253) the safe use of polyurethane polymer coating in ruminant feed
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| 2004N-0242
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| Institutional Review Boards; Registration Requirements
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004N-0330
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| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| 2004N-0436
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004N-0458
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| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
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| 2004N-0480
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| The Minor Use & Minor Species (MUMS) Animal Health Act
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| 2004N-0564
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| Agency Information Collection Activities; Proposed Collection;
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| 2004N-0565
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| Agency Information Collection Activities; Proposed Collection;
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| 2004P-0150
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| ANDA Suitability for 7.5 mg oxycodone hydrochloride/325 mg acetaminophen and 10.0 mg oxycodone hydrochloride/325 mg acetaminophen
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| 2004P-0239
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| Issue a Final and Complete Guidance Document to Determine Bioequivalence (BE) for Nasal Spray Products.
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| 2004P-0266
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| Take immediate action to cease the unlawful distribution of misbranded, adulterated and unlabeled cosmetics.
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| 2004P-0293
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| Carbohydrate Labeling - Remove Dietary Fiber from Total Carbohydrates
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| 2004P-0320
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| Refrain from approving certain applications submitted under section 505(b)(2) of the FDCA that reference Depakote (divalproex sodium delayed- release tablets)
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| 2004P-0457
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| Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
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| 2004P-0506
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| fentanyl transdermal products reduce the potential for abuse of certain types of these products
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| 2005N-0003
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug Product Labeling; Medication Guide Requirements
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| 2005P-0020
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| replace inacurate and/or misleading wording as unpasteurized and replace with the word untreated
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| 2000N-1409
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| Revision of the Identification of the Ionotophoresis
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| EC 1
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| Scripps Healthcare
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| Vol #:
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| 1
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| EC 34
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| Mr. Kenneth Richter
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| Vol #:
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| 10
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| EC 35
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| Mrs. Harriet Copperman
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| Vol #:
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| 10
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| EC
36
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| Guildford Friends of the Earth Group
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| Vol #:
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| 10
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| EC 37
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| Mr. J Cockburn
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| Vol #:
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| 10
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| EC
38
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| International Certification Services, Inc.
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| Vol #:
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| 10
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| EC 39
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| Ms. Sue Paskins
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| Vol #:
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| 10
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| EC 40
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| Friend of the Earth
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| Vol #:
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| 10
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| EC 41
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| Ms. Fran Gustman
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| Vol #:
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| 10
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| EC 42
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| Ms. Ssuan Roberts
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| Vol #:
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| 10
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| EC 43
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| Ms. Maryla Hart
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| Vol #:
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| 10
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| EC
44
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| ALliance for Nautral Food
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| Vol #:
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| 10
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| EC 45
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| Mr. Nicholas Weir
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| Vol #:
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| 10
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| 2004D-0440
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| Guidance for Industry on Computerized Systems Used in Clinical Trials
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| C
15
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| Clinical Cardiovascular Research, LLC
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| Vol #:
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| 2
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| C
16
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| Society of Quality Assurance (SQA)
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| Vol #:
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| 2
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| C
17
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 2
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| 2004D-0460
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| Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization
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| EC 2
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| Mr. Robert Baldwin
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| Vol #:
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| 1
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| 2004D-0466
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| Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act
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| C
2
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| American Herbal Products Assn (AHPA)
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| Vol #:
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| 1
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| C
3
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| Standard Process, Inc and MediHerb Pty, Ltd
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| Vol #:
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| 1
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| C
4
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| Traditional Medicinals, Inc.
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| Vol #:
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| 1
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| C
5
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| National Food Processors Assn (NFPA)
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| Vol #:
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| 1
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| C
6
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| Basic Research, LLC
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| Vol #:
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| 2
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| 2004D-0510
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| Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
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| C
2
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| Taylor Shellfish Farms
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| Vol #:
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| 1
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| C
3
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| Garbo Lobster Company, Inc.
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| Vol #:
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| 1
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| 2004D-0549
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| Guidance for Industry on Labeling OTC Human
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| GDL
1
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| Guideline
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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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| 2004F-0546
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| FAP 2253) the safe use of polyurethane polymer coating in ruminant feed
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| NFL
1
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| FDA
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| Vol #:
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| 1
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| 2004N-0242
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| Institutional Review Boards; Registration Requirements
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| EREG 1
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| Coffey, Julie
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| Vol #:
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| 1
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| | | | | | | | |
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| EREG 143
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| Conteh-Morgan, S
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| Vol #:
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| 23
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| EREG 144
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| EDWARDS, GERALD
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| Vol #:
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| 23
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| EREG 145
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| Erbe, Gale
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| Vol #:
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| 23
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| EREG 146
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| Comnes, Barbara
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| Vol #:
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| 23
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| EREG 147
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| Jebousek, Nyla
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| Vol #:
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| 23
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| 2004N-0330
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| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
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| EC 55
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| Dr. David Fassler
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| Vol #:
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| 1
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| EC 56
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| Dr. Darrel Regier
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| Vol #:
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| 1
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| C
11
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| Plasma Protein Therapeutics Assn (PPTA)
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| Vol #:
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| 4
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| C
3
Attachment
1, 2
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| Harbor-UCLA Medical Center
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| Vol #:
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| 2
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| C
4
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| University of Pittsburgh
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| Vol #:
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| 2
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| 2004N-0436
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| C
4
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| Miami Research Associates
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| Vol #:
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| 3
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| 2004N-0458
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| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
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| EC
9
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| American Heart Association
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| Vol #:
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| 1
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| EC 10
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| Mrs. Beverly Yarborough
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| Vol #:
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| 1
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| 2004N-0480
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| The Minor Use & Minor Species (MUMS) Animal Health Act
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| C
1
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| Smart Drug Systems, Inc. (Smart)
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| Vol #:
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| 1
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| EC
2
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| Keep Antibiotics Working
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| Vol #:
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| 1
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| EC
3
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| American Pet Products Manufacturers Assn.
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| Vol #:
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| 1
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| EC
4
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| Organic Trade Association
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| Vol #:
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| 1
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| 2004N-0564
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| Agency Information Collection Activities; Proposed Collection;
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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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| 2004N-0565
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| Agency Information Collection Activities; Proposed Collection;
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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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| 2004P-0150
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| ANDA Suitability for 7.5 mg oxycodone hydrochloride/325 mg acetaminophen and 10.0 mg oxycodone hydrochloride/325 mg acetaminophen
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| LET
1
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| HFD-600 to Endo Pharmaceuticals, Inc.
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| Vol #:
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| 2
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| 2004P-0239
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| Issue a Final and Complete Guidance Document to Determine Bioequivalence (BE) for Nasal Spray Products.
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| SUP
1
Tab
1
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| GlaxoSmithKline (GSK)
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| Vol #:
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| 2
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| 2004P-0266
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| Take immediate action to cease the unlawful distribution of misbranded, adulterated and unlabeled cosmetics.
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| LET
2
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| Environmental Working Group
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| Vol #:
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| 1
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| MM
1
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| Meeting between FDA and the Environmental Working Group
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| Vol #:
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| 1
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| MT
1
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| Telephone Conversation between FDA and the Environmental Working Group
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| Vol #:
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| 1
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| 2004P-0293
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| Carbohydrate Labeling - Remove Dietary Fiber from Total Carbohydrates
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| LET
1
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| HFS-800 to National Starch and Chemical Company
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| Vol #:
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| 1
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| 2004P-0320
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| Refrain from approving certain applications submitted under section 505(b)(2) of the FDCA that reference Depakote (divalproex sodium delayed- release tablets)
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| LET
2
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| HFD-005 to Hogan & Hartson
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| Vol #:
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| 1
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| 2004P-0457
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| Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
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| C
1
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| Hogan & Hartson, LLP
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| Vol #:
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| 2
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| 2004P-0506
|
| fentanyl transdermal products reduce the potential for abuse of certain types of these products
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| RC
1
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| Alza Corporation (ALZA)
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| Vol #:
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| 2
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| 2005N-0003
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug Product Labeling; Medication Guide Requirements
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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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| 2005P-0020
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| replace inacurate and/or misleading wording as unpasteurized and replace with the word untreated
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| CP
1
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| Perricone Juices
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| Vol #:
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| 1
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