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| Dockets Entered
On October 27, 2005
Table of Contents
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| Docket #
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| Title
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| 1998V-0152
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| Laser light show
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| 2000P-1322
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| Food Labeling and Allergen Contamination Control
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| 2002D-0307
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| Potassium Chloride Modified-Release Tablets and Capsules
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2004D-0283
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| Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004N-0516
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| Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
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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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| 2005D-0324
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| International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries
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| 2005D-0337
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| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque
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| 2005D-0390
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| International Conference on Harmonisation; Guidance on E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
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| 2005D-0392
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| Guidance: Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System
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| 2005FL-0434
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| Food Allergen Labeling Notification (FALN): Extensively Hydrolyzed Casein
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| 2005N-0311
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| Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop
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| 2005N-0317
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005N-0347
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| Biological Products for Treatment of Rare Plasma Protein Disorders
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| 2005N-0414
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Generic FDA Rapid Response Surveys
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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| 2005P-0046
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| removal of patent listings by reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed
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| 2005P-0116
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| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
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| 2005P-0134
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| Concerning Marketing Exclusivity for Vitrase (NDA 21-64)
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| 2005P-0397
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| Classification of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System
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| 2005P-0400
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| permission to Donna Ricks to contine using Palladone for severe chronic pain due to stage 4 metastic breast cancer
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0423
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| Immediately add a black box warning regarding the risks of drug-induced blindness for the three phosphodiesterase 5 inhibitors that are prescribed for the treatment of erectile dysfuntion
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| 2005P-0433
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| Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512
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| 1998V-0152
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| Laser light show
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| EXP 2
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| Magic Fire LaserShows, LLC
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| Vol #:
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| 1
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| 2000P-1322
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| Food Labeling and Allergen Contamination Control
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| EMC 617
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| J. Pendergrast
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| Vol #:
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| 30
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| 2002D-0307
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| Potassium Chloride Modified-Release Tablets and Capsules
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| GDL
2
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| Guideline
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| EMC 55
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| P. Bosold
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| Vol #:
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| 14
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| EMC 56
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| S. Shamblin
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| Vol #:
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| 14
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| EMC 57
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| C. Hauserman
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| Vol #:
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| 14
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| EMC 58
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| D. Gundlach
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| Vol #:
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| 14
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 545
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| Mission Possible International
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| Vol #:
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| 8
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1144
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| V. Carlisi
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| Vol #:
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| 11
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| EMC 1145
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| J. Compton
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| Vol #:
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| 11
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| EMC 1146
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| M. Dam
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| Vol #:
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| 11
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| 2004D-0283
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| Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
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| EMC 1
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| B. Sachau
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| Vol #:
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| 1
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| EMC 1147
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| I. Licea
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| Vol #:
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| 15
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| 2004N-0516
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| Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
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| EMC 3
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| B. Sachau
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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
5
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| Univerisity at Buffalo
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| Vol #:
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| 1
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| EC
3
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| University at Buffalo
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| Vol #:
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| 1
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| EC
4
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| University of Pittsburgh
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| Vol #:
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| 1
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| EC
5
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| Stony Brook University School of Dental Medicine
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| Vol #:
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| 1
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| EC
6
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| University of Missouri-Kansas City SOD
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| Vol #:
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| 1
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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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| EC
2
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| Cryonic Life Insurance Company
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| Vol #:
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| 1
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| EC
3
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| Stanford University
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| Vol #:
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| 1
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| EC
4
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| Americas Blood Centers
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| Vol #:
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| 1
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| EC
5
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| AABB
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| Vol #:
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| 1
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| EC
6
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| Armed Services Blood Program
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| Vol #:
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| 1
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| EC
7
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| Armed Services Blood Program
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| Vol #:
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| 1
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| EMC
1
Attachment
1, 2
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| Blood Systems, Inc.
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| Vol #:
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| 1
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| EMC
2
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| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 1
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| 2005D-0324
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| International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries
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| EMC
2
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| Merck & Co., Inc.
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| Vol #:
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| 1
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| 2005D-0337
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| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque
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| EC
1
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| Ms. Nicolle Singer
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| Vol #:
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| 1
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| |
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| 2005D-0390
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| International Conference on Harmonisation; Guidance on E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
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| C
1
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| AstraZeneca, LP
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| Vol #:
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| 1
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| 2005D-0392
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| Guidance: Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System
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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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| 2005FL-0434
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| Food Allergen Labeling Notification (FALN): Extensively Hydrolyzed Casein
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| FLN
1
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| Ross Products Division, Abbott Laboratories
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| Vol #:
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| 1
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| 2005N-0311
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| Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop
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| EMC
1
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| Abbott Laboratories
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| Vol #:
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| 1
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| 2005N-0317
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
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| EC
1
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| Cryonic Life Insurance Company
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| Vol #:
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| 1
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| C 219
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| E. Ross
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| Vol #:
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| 19
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| C
220
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| Planned Parenthood of Montana
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| Vol #:
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| 19
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| C 221
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| 13 signatures
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| Vol #:
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| 19
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| C 222
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| R. Hall, MD
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| Vol #:
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| 19
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| C 223
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| No signature
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| Vol #:
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| 19
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| C 224
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| A. Davis
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| Vol #:
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| 19
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| C 225
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| B. Marret
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| Vol #:
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| 19
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| | | | | | | | |
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| EMC 211
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| J. Toussaint
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| Vol #:
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| 3
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| EMC 212
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| I. Conley
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| Vol #:
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| 3
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| EMC 213
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| K. Simonian
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| Vol #:
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| 3
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| EMC 214
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| S. Jones
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| Vol #:
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| 3
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| EMC 215
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| A. Hiniker
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| Vol #:
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| 3
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| EMC 216
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| L. Pemberton
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| Vol #:
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| 3
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| 2005N-0347
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| Biological Products for Treatment of Rare Plasma Protein Disorders
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| EC
1
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| Cryonic Life Insurance Company
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| Vol #:
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| 1
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| EMC 6
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| B. Ziltz
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| Vol #:
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| 2
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| WDL
1
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| Aventis Pharmaceuticals
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| Vol #:
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| 1
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| EMC 1
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| B. Sachau
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| Vol #:
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| 1
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| |
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| 2005N-0414
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Generic FDA Rapid Response Surveys
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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-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| PDN
1
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| HFD-001 to Ivax Pharmaceuticals, Inc.
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| Vol #:
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| 2
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| 2005P-0046
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| removal of patent listings by reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed
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| PDN
1
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| HFD-001 to Ranbaxy Laboratories Limited
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| Vol #:
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| 2
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|
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| 2005P-0116
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| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
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| EMC 8
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| R. Rodriguez
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| Vol #:
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| 2
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| EMC 9
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| C. Finkelstein
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| Vol #:
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| 2
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| 2005P-0134
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| Concerning Marketing Exclusivity for Vitrase (NDA 21-64)
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| PDN
1
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| HFD-001 to ISTA Pharmaceuticals
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| Vol #:
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| 1
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| EMC 2
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| M. Richardson, CRNA
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| Vol #:
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| 13
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|
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| 2005P-0397
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| Classification of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System
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|
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| NFR 1
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| FDA
|
| Vol #:
|
| 1
|
|
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| 2005P-0400
|
| permission to Donna Ricks to contine using Palladone for severe chronic pain due to stage 4 metastic breast cancer
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