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| Dockets Entered
On August 9, 2007
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| Docket #
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| Title
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| 2001D-0286
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| In Vitro HIV Drug Resistance Genotype Assays [510(k)s]
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| 2002D-0081
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| Hepatitis B Surface Antigen (HBSAG) Assays to Test Blood
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005N-0272
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| Irradiation in the Production, Processing & Handling of Food
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| 2006P-0302
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| Permit the filing of an ANDA Suitability for Sodium Chloride Injection
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| 2007D-0125
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| Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
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| 2007D-0213
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| Guidance for Industry on Providing Regulatory Submissions in Electronic Format Receipt Date
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| 2007D-0268
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
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| 2007N-0050
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Label Comprehension Study
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| 2007N-0179
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| Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop
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| 2007P-0097
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| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
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| 2007P-0187
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| Requirements of Iodized Salt on Ingredient Labels
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| 2007P-0282
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| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
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| 2001D-0286
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| In Vitro HIV Drug Resistance Genotype Assays [510(k)s]
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| REF 1
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| References
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| Vol #:
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| 2
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| 2002D-0081
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| Hepatitis B Surface Antigen (HBSAG) Assays to Test Blood
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| REF 1
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| References
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| Vol #:
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| 2
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| C 4
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| C. Harris
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| Vol #:
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| 3
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| CS 28
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| FDA/DDM
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| Vol #:
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| 245
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| OR 25
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| FDA/Administrative Law Judge
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| Vol #:
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| 245
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| 2005N-0272
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| Irradiation in the Production, Processing & Handling of Food
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| C 3622
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| MDS Nordion
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| Vol #:
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| 47
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| C 3623
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| Unknown
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| Vol #:
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| 47
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| C 3624
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| J. Herd
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| Vol #:
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| 47
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| C 3625
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| B. Sanders
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| Vol #:
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| 47
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| C 3626
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| S. Yerger
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| Vol #:
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| 47
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| C 3627
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| L. Risdon
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| Vol #:
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| 47
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| EC 3
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| Sanofi Pasteur
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| Vol #:
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| 1
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| EC 4
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| sanofi-aventis
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| Vol #:
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| 1
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| 2007D-0268
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
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| EC 1
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| Ms. Renee Cummings
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| Vol #:
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| 1
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| 2007N-0050
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Label Comprehension Study
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| EC 5
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| Mr. bill wells
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| Vol #:
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| 1
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| 2007N-0179
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| Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop
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| EC 4
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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 5
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| Healthcare Distribution Management Association
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| Vol #:
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| 1
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| EC 6
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| Academy of Managed Care Pharmacy
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| Vol #:
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| 1
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| EC 7
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| NACDS
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| Vol #:
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| 1
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| 2007P-0097
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| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
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| EC 5
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| Mrs. Lisa Letarte
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| Vol #:
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| 1
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| 2007P-0187
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| Requirements of Iodized Salt on Ingredient Labels
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| EC 1
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| Mrs. Lucinda Brisendine
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| Vol #:
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| 1
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| 2007P-0282
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| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
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| EC 1
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| Massachusetts Institute of Technology
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| Vol #:
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| 1
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| EC 2
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| Ms. Pat Mainer
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| Vol #:
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| 1
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| EC 3
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| Mr. Joshua Rosen
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| Vol #:
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| 1
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