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| Dockets Entered
On May 25, 2007
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| Docket #
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| Title
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| 1977N-0094L
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| Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
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| 1998D-0777
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| Investigating out of Specification(OOS)Test Results fr Pharm
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| 2001D-0221
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| Biological Product Deviation Reporting for Licensed Manufact
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| 2001D-0432
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| Evalution of the effects of Orally Inhaled and Intranasal
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2003V-0179
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| Laser Light Show
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| 2005D-0112
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| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
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| 2006E-0495
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| Patent Extension Application for Model KDR401 and KRD403 Pacemaker, U.S. Patent No. 4,958,632
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| 2006E-0502
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| Patent Extension Application for Prezista (darunavir ethanolate), U.S. Patent No. 6,248,775
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| 2006E-0516
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| Patent Extension Application for SPRYCEL (dasatinib), U.S. Patent No. 6,596,746
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| 2007D-0020
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| Medical Devices: Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices
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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-0027
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| Voluntary Self Inspection of Medicated Feed Manufacturing Facilities
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| 2007D-0080
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| Guidance for Industry on Indexing Structured Product Labeling
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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-0118
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| Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
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| 2007E-0009
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| Patent Extension Application for Myozyme (Aglucosidase alfa), U.S. Patent No. 6,118,045
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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-0200
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Comment Request; Health and Diet Survey
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| 2007N-0208
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| Interim Melamine and Melamine Analogues Safety/Risk Assessment; Availability
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| 2007P-0214
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| ANDA Suitability for Cefazolin Injection, USP 2 g Vials
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| 2007Q-0192
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| Health Claim Notification: Unsaturated Fatty Acids and Risk of Heart Disease
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| 2007V-0141
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| Laser Light Show
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| |
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| EC 1
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| A Brand New Kind Of Dinasaur
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| Vol #:
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| 200
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| EC 2
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| Ms. charisse Texeira
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| Vol #:
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| 200
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| EC 3
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| Ms. Caroline Miles
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| Vol #:
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| 200
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| 1977N-0094L
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| Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
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| C 1
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| National Kidney Foundation, Inc.
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| Vol #:
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| 1
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| C 2
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| American Academy of Family Physicians
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| Vol #:
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| 1
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| C 3
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| National Association of Chain Drug Stores
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| Vol #:
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| 1
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| C 4
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| Bayer HealthCare
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| Vol #:
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| 1
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| C 5
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| Consumer Healthcare Products Association
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| Vol #:
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| 1
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| C 6
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| Consumer Healthcare Products Association
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| Vol #:
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| 1
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| 1998D-0777
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| Investigating out of Specification(OOS)Test Results fr Pharm
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| EC 2
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| Ms. charisse texeira
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| Vol #:
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| 2
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| 2001D-0221
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| Biological Product Deviation Reporting for Licensed Manufact
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| EC 3
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| Ms. Caroline Miles
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| Vol #:
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| 1
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| 2001D-0432
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| Evalution of the effects of Orally Inhaled and Intranasal
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| EC 2
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| Ms. charisse texeira
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| Vol #:
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| 1
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| EC 39
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| Ms. charisse Texeira
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| Vol #:
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| 6
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| EC 8156
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| Mr. Jason Lorenzen
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| Vol #:
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| 65
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| EC 8157
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| Union of Concerned Scientists
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| Vol #:
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| 186
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| EC 8158
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| Union of Concerned Scientists
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| Vol #:
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| 187
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| 2003V-0179
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| Laser Light Show
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| ACK 2
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| FDA/DDM to Musititlan Entertainment
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| Vol #:
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| 1
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| VAR 2
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| Musititlan Entertainment
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| Vol #:
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| 1
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| EC 33
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| Foote Health System
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| Vol #:
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| 1
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| 2005D-0112
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| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
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| EC 9
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| Dr. michael weiner
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| Vol #:
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| 1
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| EC 10
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| Phy. Health Specialist
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| Vol #:
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| 1
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| EC 11
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| Mr. Robert Youngs
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| Vol #:
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| 1
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| 2006E-0495
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| Patent Extension Application for Model KDR401 and KRD403 Pacemaker, U.S. Patent No. 4,958,632
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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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| 2006E-0502
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| Patent Extension Application for Prezista (darunavir ethanolate), U.S. Patent No. 6,248,775
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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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| 2006E-0516
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| Patent Extension Application for SPRYCEL (dasatinib), U.S. Patent No. 6,596,746
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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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| 2007D-0020
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| Medical Devices: Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices
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| EC 1
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| Mr. GW Seals
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| Vol #:
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| 1
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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 1
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| ThermoGenesis
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| Vol #:
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| 2
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| 2007D-0027
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| Voluntary Self Inspection of Medicated Feed Manufacturing Facilities
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| EC 4
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| U.S. CITIZEN
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| Vol #:
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| 1
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| 2007D-0080
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| Guidance for Industry on Indexing Structured Product Labeling
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| EC 1
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| Baxter Healthcare Corporation
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| Vol #:
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| 1
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| EC 2
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| GlaxoSmithKline
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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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| EC 1
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| Smith and Nephew
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| Vol #:
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| 1
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| EC 2
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| Smith and Nephew
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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 2
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| Rush University Medical Center
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| Vol #:
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| 1
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| EC 3
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| Kestrel Consultants, Inc.
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| Vol #:
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| 1
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| EC 4
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| Western Institutional Review Board
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| Vol #:
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| 1
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| EC 5
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| Park Nicollet Institute
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| Vol #:
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| 1
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| EC 6
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| IRB, Baystate Med Center-Tufts Univ School of Med
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| Vol #:
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| 1
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| 2007D-0117
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| Guidance for Industry on Orally Disintegrating Tablets
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| EC 1
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| SPI Pharma Inc.
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| Vol #:
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| 1
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| 2007D-0118
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| Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
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| EC 2
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| University of Iowa
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| Vol #:
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| 1
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| 2007E-0009
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| Patent Extension Application for Myozyme (Aglucosidase alfa), U.S. Patent No. 6,118,045
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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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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| EAPE 226
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| Varasteh, Laleh
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| Vol #:
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| 7
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| EAPE 227
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| Stevens, Leslie
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| Vol #:
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| 7
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| EAPE 228
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| varasteh, laleh
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| Vol #:
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| 7
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| 2007N-0200
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Comment Request; Health and Diet Survey
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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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| 2007N-0208
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| Interim Melamine and Melamine Analogues Safety/Risk Assessment; Availability
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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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| RA 1
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| Risk Assessment
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| Vol #:
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| 1
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| REF 1
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| Reference (Apendix I of theRisk Assessment)
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| Vol #:
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| 2
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| 2007P-0214
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| ANDA Suitability for Cefazolin Injection, USP 2 g Vials
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| ACK 1
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| FDA / DDM to Sandoz, Inc.
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| Vol #:
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| 1
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| 2007Q-0192
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| Health Claim Notification: Unsaturated Fatty Acids and Risk of Heart Disease
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| ACK 1
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| FDA/CFSAN to Frito-Lay, Inc
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| Vol #:
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| 2
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| HCN 1
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| Frito-Lay, Inc
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| Vol #:
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| 1
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| LET 1
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| Frito-Lay, Inc
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| Vol #:
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| 2
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| 2007V-0141
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| Laser Light Show
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| CR 1
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| FDA/DDM to Boulevard Investments, LLC
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| Vol #:
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| 1
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