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| Dockets Entered
On April 25, 2005
Table of Contents
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| Docket #
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| Title
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| 1977N-0094I
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| Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro
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| 1978N-0038
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| Sunscreen Drug Products
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| 1998D-0514
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| Industry on ANDA's: Impurities in Drug Substances
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| 2000D-1383
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| Surveillance & Detention w/o Physical Examination of Condoms
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002N-0277
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| Bioterrorism; Establishment & Maintenance of Records
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| 2004N-0242
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| Institutional Review Boards; Registration Requirements
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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-0463
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| Food Labeling: Prominence of Calories
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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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| 2004Q-0097
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| Qualified Health Claim: Calcium and various cancers
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| 2004Q-0098
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| Qualified Health Claim: Calcium and hypertension
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| 2004Q-0099
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| Qualified Health Claim: Calcium and menstrual disorders
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| 2004Q-0102
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| Qualified Health Claim: Calcium and Kidney/urinary stones
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| 2004Q-0144
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| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 2004Q-0201
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| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
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| 2005D-0030
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| Guidance for Industry on Clinical Lactation Studies Study Design, Data Analysis, and Recommendations for Labeling
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| 2005D-0103
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| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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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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| 2005P-0013
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| Cefixime for Oral Suspension, 200 mg/mL, as an Abbreviated New Drug Applicaton(ANDA)
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| 2005P-0044
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| ANDA Suitability for Chlorozoxazone Tablets USP, 375 mg
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| 2005P-0060
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| Hydrochlorothiazide Tablets 12.5 mg, is suitable for submission in an ANDA
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| 2005P-0080
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| ANDA Suitability for Prednisolone Sodium Phosphate Solution 10 mg/5 mL, 20 mg/5 mL and 25 mg/5 mL (equivalent prednisolone base)
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| 2005P-0090
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| Amend or revoke 5 CFR 5501.101(c)(2) based upon a review of the basis, intended purpose and actual societal needs
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| 2005P-0093
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| Revoke part of 5 CFR 5501.104(b)(3) prohibits owership of financial interest in a publicly traded or publicly available inestment funds
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| MT
16
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| HFD-560 and Consumer Healthcare Products Assn (CHPA)
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| Vol #:
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| 257
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| 1977N-0094I
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| Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro
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| MT
1
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| HFD-560 and Consumer Healthcare Products Assn (CHPA)
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| Vol #:
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| 10
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| 1978N-0038
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| Sunscreen Drug Products
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| CR 9
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| Number not used
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| Vol #:
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| 150
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| 1998D-0514
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| Industry on ANDA's: Impurities in Drug Substances
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| C
8
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| Sanofi-Synthelabo, Inc. and Aventis Pharmaceuticals (Sanofi Aventis)
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| Vol #:
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| 1
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| 2000D-1383
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| Surveillance & Detention w/o Physical Examination of Condoms
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| C
2
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| Ansell Healthcare (Ansell)
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| Vol #:
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| 1
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 2086
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| P. Harrington
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| Vol #:
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| 300
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| C 2087
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| B. McCall
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| Vol #:
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| 300
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| 2002N-0277
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| Bioterrorism; Establishment & Maintenance of Records
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| TR
1
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| 2/1/2005 Transcript on Domestic Outreach Grassroots Meeting held in Boston, Massachusetts
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| Vol #:
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| 21
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| TR
2
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| 2/1/2005 Transcript on Domestic Outreach Grassroots Meeting held in Philadelphia, Pennsylvania
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| Vol #:
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| 22
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| TR
3
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| 1/25/2005 Transcript on Domestic Outreach Grassroots Meeting held in Chicago, Illinois
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| Vol #:
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| 23
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| TR
4
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| 1/25/2005 Transcript on Domestic Outreach Grassroots Meeting held in Seattle, Washington
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| Vol #:
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| 24
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| TR
5
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| 1/27/2005 Transcript on Domestic Outreach Grassroots Meeting held in San Francisco, California
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| Vol #:
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| 25
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| 2004N-0242
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| Institutional Review Boards; Registration Requirements
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| REF
1
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| OMB Review of NPR1 published 07/06/2004
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| Vol #:
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| 1
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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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| C
2
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| American Osteopathic Association
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| Vol #:
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| 1
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| C 23
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| Mr. J. C. Groen
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| Vol #:
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| 1
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| REF
1
Tab
A, Tab
B, Tab
C
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| OMB review ANPR published 4-4-2005
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| Vol #:
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| 1
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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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| C
1
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| American Red Cross (Red Cross)
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| Vol #:
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| 1
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| 2004Q-0097
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| Qualified Health Claim: Calcium and various cancers
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| LET
7
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| Marine Bio Co. Ltd
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| Vol #:
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| 15
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| 2004Q-0098
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| Qualified Health Claim: Calcium and hypertension
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| LET
9
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| Marine Bio Co Ltd
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| Vol #:
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| 9
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| 2004Q-0099
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| Qualified Health Claim: Calcium and menstrual disorders
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| LET
7
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| Marine Bio Co Ltd
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| Vol #:
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| 4
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| 2004Q-0102
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| Qualified Health Claim: Calcium and Kidney/urinary stones
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| LET
7
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| Marine Bio Co Ltd
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| Vol #:
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| 6
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| 2004Q-0144
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| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
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| LET
6
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| Nutrition 21 Inc
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| Vol #:
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| 11
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| C 99
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| J. Acia
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| Vol #:
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| 9
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| C 100
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| L. Fulwider
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| Vol #:
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| 9
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| EXT
1
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| The Solae Company
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| Vol #:
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| 9
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| 2004Q-0201
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| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
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| LET
5
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| American Longevity Inc
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| Vol #:
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| 16
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| 2005D-0030
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| Guidance for Industry on Clinical Lactation Studies Study Design, Data Analysis, and Recommendations for Labeling
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| C
6
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| Eli Lilly and Company (Lilly)
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| Vol #:
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| 1
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| 2005D-0103
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| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
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| C 1
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| B. Lenich
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| Vol #:
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| 1
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| C
5
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| Cook Group, Inc. (Cook)
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| Vol #:
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| 3
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| C
6
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| GlaxoSmithKline (GSK)
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| Vol #:
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| 3
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| C
7
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| MedImmune, Inc.
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| Vol #:
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| 3
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| C
8
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| AstraZeneca, LP
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| Vol #:
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| 3
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| C
9
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| Novartis Pharmaceuticals Corporation (Novartis)
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| Vol #:
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| 3
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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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| C
2
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| Assn of Food and Drug Officials (AFDO)
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| Vol #:
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| 1
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| 2005P-0013
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| Cefixime for Oral Suspension, 200 mg/mL, as an Abbreviated New Drug Applicaton(ANDA)
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| PAV
1
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| HFD-600 to Lupin Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2005P-0044
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| ANDA Suitability for Chlorozoxazone Tablets USP, 375 mg
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| PAV
1
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| HFD-600 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2005P-0060
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| Hydrochlorothiazide Tablets 12.5 mg, is suitable for submission in an ANDA
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| PAV
1
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| HFD-600 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2005P-0080
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| ANDA Suitability for Prednisolone Sodium Phosphate Solution 10 mg/5 mL, 20 mg/5 mL and 25 mg/5 mL (equivalent prednisolone base)
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| PAV
1
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| HFD-600 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2005P-0090
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| Amend or revoke 5 CFR 5501.101(c)(2) based upon a review of the basis, intended purpose and actual societal needs
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| C 1
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| J. Bryce
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| Vol #:
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| 1
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