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| Dockets Entered
On June 6, 2007
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| Docket #
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| Title
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| 1999D-1651
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| Chemistry,Mfging/Control Changes to an approved NADA/ANADA
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| 2000E-1253
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| Patent Extension Application for RAPLON (rapacuronium bromide), U.S. Patent No. 5,418,226
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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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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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| 2006N-0479
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| Insect Repellent-Sunscreen Drug Products for Over-the-Counter Human Use
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| 2007D-0025
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| Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container; Availability
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| 2007D-0083
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| Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process
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| 2007D-0106
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| Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection
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| 2007D-0117
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| Guidance for Industry on Orally Disintegrating Tablets
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| 2007D-0168
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| Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
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| 2007D-0169
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| Guidance for Industry Bioequivalence Recommendations for Specific Products
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| 2007D-0173
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| Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
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| 2007N-0051
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| Safety of Fresh Produce; Public Hearings
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| 2007N-0090
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| Zimulti Endocrinologic and Metabolic Drugs Advisory Committee Meeting, June 13, 2007
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| 2007N-0105
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Food Bioterrorism Risk Awareness
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 2007N-0215
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| Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
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| 1999D-1651
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| Chemistry,Mfging/Control Changes to an approved NADA/ANADA
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| GDL 2
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| Guidance
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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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| 2000E-1253
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| Patent Extension Application for RAPLON (rapacuronium bromide), U.S. Patent No. 5,418,226
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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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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| EC 98
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| Mr. GW Seals
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| Vol #:
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| 8
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| EC 99
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| Mrs. Peggy Hostettler
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| Vol #:
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| 8
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| C 1221
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| A. Leonard
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| Vol #:
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| 68
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| C 1222
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| K. Gibbs
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| Vol #:
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| 68
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| |
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| EC 27
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| Mrs. Wanda Chapman
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| Vol #:
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| 2
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| EC 293
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| Ms. Mary Johnson
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| Vol #:
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| 6
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| EC 294
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| Ms. Caroline MIles
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| Vol #:
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| 6
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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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| EC 33275
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| Ms. Laura Pappis
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| Vol #:
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| 197
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| EC 33276
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| Mrs. Darlene Brummond
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| Vol #:
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| 197
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| EC 33277
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| Mrs. wendy teague
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| Vol #:
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| 201
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| EC 33278
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| Ms. Debrah Roemisch
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| Vol #:
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| 197
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| EC 33279
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| Ms. A. Butler
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| Vol #:
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| 197
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| EC 33280
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| Mrs. Cynthia Thompson
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| Vol #:
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| 197
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| EC 33281
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| Mrs. Patricia Kays
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| Vol #:
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| 197
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| EC 33282
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| Ms. Samantha McTighe
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| Vol #:
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| 197
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| EC 33283
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| Mr. Lyle Gurnsey
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| Vol #:
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| 197
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| EC 33284
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| none
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| Vol #:
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| 197
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| EC 33285
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| Mr. jakob sohn
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| Vol #:
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| 197
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| EC 33286
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| Miss. Jennifer Johnson
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| Vol #:
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| 197
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| EC 33287
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| Ms. Victoria Smith
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| Vol #:
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| 197
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| EC 33288
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| Mrs. Laraine Aubuchon
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| Vol #:
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| 197
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| EC 33289
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| private citizen
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| Vol #:
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| 197
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| BKG 1
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| Background Information
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| Vol #:
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| 2
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| EA 1
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| Environmental Assessment
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| Vol #:
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| 1
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| FONS 1
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| Findings of No Significant Impact
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| Vol #:
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| 1
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| NPR 1
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| FDA
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| Vol #:
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| 1
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| 2006N-0479
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| Insect Repellent-Sunscreen Drug Products for Over-the-Counter Human Use
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| EC 1
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| American Academy of Pediatrics
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| Vol #:
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| 1
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| EC 2
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| CSPA / DEET Task Force
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| Vol #:
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| 1
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| EC 3
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| CSPA / DEET Task Force
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| Vol #:
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| 3
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| 2007D-0025
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| Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container; Availability
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| EC 2
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| AdvaMed (Advanced Medical Technology Association)
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| Vol #:
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| 1
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| 2007D-0083
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| Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process
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| | | | | | | | |
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| EC 3
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| ELA Medical, Inc; a subsidiary of Sorin Group
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| Vol #:
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| 1
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| 2007D-0106
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| Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection
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| EC 7
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| Council on Governmental Relations
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| Vol #:
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| 1
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| |
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| 2007D-0117
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| Guidance for Industry on Orally Disintegrating Tablets
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| EC 3
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| Mallinckrodt Inc.
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| Vol #:
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| 1
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| EC 4
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| CIMA LABS INC.
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| Vol #:
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| 1
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| 2007D-0168
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| Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
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|
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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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|
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| 2007D-0169
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| Guidance for Industry Bioequivalence Recommendations for Specific Products
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|
|
|
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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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|
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| 2007D-0173
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| Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
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| EC 1
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| Catholic Healthcare West
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| Vol #:
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| 1
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| 2007N-0051
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| Safety of Fresh Produce; Public Hearings
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| EC 11
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| California Cantaloupe Advisory Board
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| Vol #:
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| 2
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| EC 12
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| NSF International
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| Vol #:
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| 2
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| 2007N-0090
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| Zimulti Endocrinologic and Metabolic Drugs Advisory Committee Meeting, June 13, 2007
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| EC 4
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| Mr. Raymond Braun
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| Vol #:
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| 1
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| 2007N-0105
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Food Bioterrorism Risk Awareness
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| EC 1
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| (Member) Mount Vernon Farmer's Market
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| Vol #:
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| 1
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| EAPE 255
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| Lennartz, Crystal
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| Vol #:
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| 7
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| 2007N-0215
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| Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
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| NM 1
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| FDA
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| Vol #:
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| 1
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