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| Dockets Entered
On July 25, 2007
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| Docket #
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| Title
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| 1985V-0284
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| Starlight series one laser light show
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| 1985V-0287
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| Laser light show & projector
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| 1996V-0210
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| Variance for Laser Light Show
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| 1999V-4395
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| Laser Light Show
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| 2004P-0448
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| DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| 2006D-0480
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| Guidance for Industry
on Complementary & Alternative Medicine Products & Their Regulation
by the Food and Drug Administration
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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-0123
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| Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0405
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| Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
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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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| 2007E-0057
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| Patent Extension Application for EMSAM (selegiline transdermal system), U.S. Reissue No. 34,579
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| 2007N-0165
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice
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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-0034
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| To make a determination on three (3) reference listed drug products that have not been withdrawn from commercial distribution for reasons other than safety or effectiveness
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| 2007P-0052
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| Determine whether a Reference Listed drug Brethine has been voluntarily withdrawn from distribution and sale for reasons other than safety or effectiveness, and thus permit the filing of an ANDA for B
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| 1985V-0284
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| Starlight series one laser light show
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| VRA 11
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| Lynne L. Rice
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| Vol #:
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| 1
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| 1985V-0287
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| Laser light show & projector
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| VRA 11
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| Lynne L. Rice
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| Vol #:
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| 1
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| C 256
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| Form Letter Count 15
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| Vol #:
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| 52
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| 1996V-0210
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| Variance for Laser Light Show
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| VRA 7
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| Lynne Rice
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| Vol #:
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| 1
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| 1999V-4395
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| Laser Light Show
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| VAR 2
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| Lightwave International, Inc
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| 1
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| 2004P-0448
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| DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
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| AMD 3
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| Hill Dermaceuticals, Inc
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| Vol #:
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| 1
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| LET 5
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| Miriam Provost, Ph.D.
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| Vol #:
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| 7
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| 2006D-0480
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| Guidance for Industry
on Complementary & Alternative Medicine Products & Their Regulation
by the Food and Drug Administration
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| C 1365
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| Duane Dewispelaere
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| Vol #:
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| 25
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| C 4
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| University of Colorado Health Sciences Center
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| Vol #:
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| 1
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| C 5
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| American Association for Respiratory Care
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| Vol #:
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| 1
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| C 6
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| Sunrise Pulmonary Group, Inc.
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| Vol #:
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| 1
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| C 7
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| Southdale Allergy and Asthmna Clinic, LLC
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| Vol #:
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| 1
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| EXT 2
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| GRACEWAY PHARMACEUTICALS
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| Vol #:
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| 1
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| 2006P-0123
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| Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
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| ACK 2
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| FDA/DDM to Mylan Technologies Inc.
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| Vol #:
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| 1
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| PSA 1
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| Mylan Technologies Inc.
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| Vol #:
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| 1
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| C 107
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| Claire Bresnahan
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| Vol #:
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| 7
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| C 108
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| Bryan Todd
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| Vol #:
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| 7
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| C 109
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| Mrs Eric Feirtag
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| Vol #:
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| 7
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| C 110
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| Linsay Collins
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| Vol #:
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| 7
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| 2006P-0405
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| Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
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| C 7
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| Wayne L. Pines
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| Vol #:
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| 2
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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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| C 5
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| Western Institutional Review Board
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| Vol #:
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| 1
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| 2007E-0057
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| Patent Extension Application for EMSAM (selegiline transdermal system), U.S. Reissue No. 34,579
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| ADV 1
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| U.S. Patent and Trademark Office to Vinson & Elkins, L.L.P.
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| Vol #:
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| 1
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| 2007N-0165
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice
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| N 2
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| FDA
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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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| BKG 1
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| Handout-William Vaugh
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| Vol #:
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| 1
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| LST 1
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| American Medical Association
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| Vol #:
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| 1
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| TS 1
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| Joseph W. Cranston
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| Vol #:
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| 1
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