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| Dockets Entered
On July 28, 2005
Table of Contents
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| Docket #
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| Title
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| 2000N-0504
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| Egg Safety Action Plan
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2002N-0510
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| Proposal to Debar Thomas M. Rodgers, Jr.
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| 2003D-0180
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| Guidance for Industry and the Food and Drug Administration; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile; Availability; Reques
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| 2003E-0410
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| Patent Term Restoration Application for Zubrin (tepoxalin), U.S. Patent No. 4,826,868
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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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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004P-0294
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| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| 2005D-0174
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| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
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| 2005D-0183
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| Guidance for Industry on Antiviral Drug Development Conducting Virology Studies and Submitting the Data to the Agency
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| 2005D-0203
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| Guidance for Industry on Safety Testing of Drug Metabolites
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| 2005D-0261
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| Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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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-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 2005P-0048
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| Professional labeling for aspirin dosing in order to specify the morefavorable benefit/risk profile of aspirin doses of 75-150 mg/day for secondary cardiovascular prevention, 5-=150 mg/day for seconda
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| 2005P-0094
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| Remove the drug Iressa (gefitnib; AstraZeneca) from the market immediately
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| 2005Q-0297
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| Qualified Health Claim: Green Tea and Reduced Risk of Cardiovascular Disease
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| 2000N-0504
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| Egg Safety Action Plan
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| EC 25
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| Center for Science in the Public Interest
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| Vol #:
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| 32
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| CMD
1
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| HF-1
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| Vol #:
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| 504
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| 2002N-0510
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| Proposal to Debar Thomas M. Rodgers, Jr.
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| BKG
1
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| Tabs 1 - 4
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| Vol #:
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| 1
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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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| 2003D-0180
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| Guidance for Industry and the Food and Drug Administration; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile; Availability; Reques
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| EC 1
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| Mr. giulio giove
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| Vol #:
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| 1
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| 2003E-0410
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| Patent Term Restoration Application for Zubrin (tepoxalin), U.S. Patent No. 4,826,868
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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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| 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 5
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| Ms. Sherrill Gibbs
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| Vol #:
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| 1
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| CS
11
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| HFA-305
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| Vol #:
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| 2
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| OR
10
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| HF-3
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| Vol #:
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| 2
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| 2004P-0294
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| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
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| EC
3
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| McNeil Nutritionals, LLC
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| Vol #:
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| 2
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| EC
3
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| National Association of Boards of Pharmacy
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| Vol #:
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| 1
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| EC
4
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| University of Leeds
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| Vol #:
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| 1
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| EC
5
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| Gold Standard, Inc.
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| Vol #:
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| 1
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| EC
6
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| National Association of Chain Drug Stores
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| Vol #:
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| 1
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| EC
7
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| Catalina Health Resource
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| Vol #:
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| 1
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| EC
8
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| First DataBank, Inc.
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| Vol #:
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| 1
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| EC
9
Attachment
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| American Society of Health-System Pharmacists
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| Vol #:
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| 1
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| EC
10
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| Public Citizen's Health Research Group
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| Vol #:
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| 1
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| EC
11
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| American Pharmacists Association
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| Vol #:
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| 1
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| EC
12
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| AARP
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| Vol #:
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| 1
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| EC 13
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| Thomson Healthcare
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| Vol #:
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| 1
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| EC
14
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| Wolters Kluwer Health
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| Vol #:
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| 1
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| EC
15
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| American Society of Health-System Pharmacists
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| Vol #:
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| 1
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| EC
16
Attachment
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| American Society of Health-System Pharmacists
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| Vol #:
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| 1
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| EC
17
Attachment
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| American Society of Health-System Pharmacists
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| Vol #:
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| 1
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| 2005D-0174
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| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
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| EC
6
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| Covenant Medical Center
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| Vol #:
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| 1
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| 2005D-0183
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| Guidance for Industry on Antiviral Drug Development Conducting Virology Studies and Submitting the Data to the Agency
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| EC
1
Attachment
1, 2
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| Hoffmann-La Roche, Inc.
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| Vol #:
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| 1
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| EC 2
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| Pfizer Inc
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| Vol #:
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| 1
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| EC
3
Attachment
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| Trimeris, Inc
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| Vol #:
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| 1
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| EC
4
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| Schering-Plough
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| Vol #:
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| 1
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| EC
5
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| GlaxoSmithKline
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| Vol #:
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| 1
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| 2005D-0203
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| Guidance for Industry on Safety Testing of Drug Metabolites
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| EC
1
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| Alcon Research, Ltd.
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| Vol #:
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| 1
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| C
1
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| WhiteHill Oral Technologies, Inc.
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| Vol #:
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| 1
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| |
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| 2005D-0261
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| Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
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|
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| BKG
1
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| Tabs 1 - 13
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| Vol #:
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| 1
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| EC
10
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| American Thyroid Association
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| Vol #:
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| 1
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| EC
11
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| The Endocrine Society
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| Vol #:
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| 1
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| EC
12
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| American Association of Clinical Endocrinologists
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| Vol #:
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| 1
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| EC
13
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| ThyCa: Thyroid Cancer Survivors' Association, Inc.
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| Vol #:
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| 1
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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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| EC
4
Attachment
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| Harvard Medical School
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| Vol #:
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| 1
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| BKG
1
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| Reference 1 - 11 found in 70FR41356
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| Vol #:
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| 1
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| EC
1
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| Oregon State University
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| Vol #:
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| 1
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| EC
2
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| Mrs. Lois Mellon
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| Vol #:
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| 1
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| EC
3
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| Mrs. Rachelle Hartze
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| Vol #:
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| 1
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| EC
4
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| Mrs. Jennifer Brown
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| Vol #:
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| 1
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| 2005P-0048
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| Professional labeling for aspirin dosing in order to specify the morefavorable benefit/risk profile of aspirin doses of 75-150 mg/day for secondary cardiovascular prevention, 5-=150 mg/day for seconda
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| LET
1
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| HFD-1 to McNeil Consumer & Specialty Pharmaceuticals
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| Vol #:
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| 1
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| 2005P-0094
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| Remove the drug Iressa (gefitnib; AstraZeneca) from the market immediately
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| C
2
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| Washington Legal Foundation
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| Vol #:
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| 1
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| 2005Q-0297
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| Qualified Health Claim: Green Tea and Reduced Risk of Cardiovascular Disease
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| ACK
1
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| HFS-830 to AAC Consulting Group
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| Vol #:
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| 1
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| QHC
1
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| AAC Consulting Group
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| Vol #:
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| 1
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