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| Dockets Entered
On August 5, 2005
Table of Contents
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| Docket #
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| Title
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| 1991V-0204
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| Laser Light Show
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| 2004D-0187
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| Guidance for Industry on Premarketing Risk Assessment
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| 2004D-0333
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| Emergency Use Authorization of Medical Products
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| 2004D-0422
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| Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)
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| 2004D-0460
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| Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization
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| 2004N-0458
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| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| 2005D-0174
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| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
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| 2005D-0203
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| Guidance for Industry on Safety Testing of Drug Metabolites
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 2005P-0048
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| Professional labeling for aspirin dosing in order to specify the morefavorable benefit/risk profile of aspirin doses of 75-150 mg/day for secondary cardiovascular prevention, 5-=150 mg/day for seconda
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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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| 2005V-0230
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| Laser Light Show
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| 2005V-0260
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| Laser Light Show
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| 2005V-0287
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| Projector for a Laser Light Show
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| 2005V-0309
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| Laser Light Show
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| 1991V-0204
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| Laser Light Show
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| VRA
7
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| HFZ-200 to Mare-Bare, Inc./dba Stardust Resort & Casino
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| Vol #:
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| 1
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| 2004D-0187
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| Guidance for Industry on Premarketing Risk Assessment
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| EC 4
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| Mr. Chris Paulse
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| Vol #:
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| 1
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| 2004D-0333
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| Emergency Use Authorization of Medical Products
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| EC 1
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| Ms. Andrea Sutherland
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| Vol #:
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| 1
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| 2004D-0422
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| Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)
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| EC 2
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| Ms. Andrea Sutherland
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| Vol #:
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| 1
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| 2004D-0460
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| Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization
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| EC 6
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| Ms. Andrea Sutherland
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| Vol #:
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| 1
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| 2004N-0458
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| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
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| EC 42
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| Mr. Chris Paulse
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| 1
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| C 53
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| Ms. J. C. Wimmer
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| Vol #:
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| 4
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| C
6
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| Novartis Pharmaceuticals Corporation
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| Vol #:
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| 1
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| 2005D-0174
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| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
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| EC 7
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| Ms. Andrea Sutherland
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| Vol #:
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| 1
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| 2005D-0203
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| Guidance for Industry on Safety Testing of Drug Metabolites
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| C
6
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| AtraZeneca Pharmaceuticals, LP
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| Vol #:
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| 1
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| C
7
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| Pfizer, Inc.
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| Vol #:
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| 1
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| EC
2
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| Johnson
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| Vol #:
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| 1
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| EC
3
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| Amgen
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| Vol #:
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| 1
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| EC
4
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| Amgen
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| Vol #:
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| 1
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| EC
5
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| Pfizer
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| Vol #:
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| 1
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| EC
6
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| GlaxoSmithKline
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| Vol #:
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| 1
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| EC
7
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| Novartis Pharmaceuticals Inc.
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| Vol #:
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| 1
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| EC
8
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| Novartis Pharmaceuticals Inc.
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| Vol #:
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| 1
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| EC 4
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| Mr. paul bavaro
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| Vol #:
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| 1
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| EC
15
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| Mrs. Laura Gasser
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| Vol #:
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| 1
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| EC
16
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| Ms. Laura Hatfield
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| Vol #:
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| 1
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| 2005P-0048
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| Professional labeling for aspirin dosing in order to specify the morefavorable benefit/risk profile of aspirin doses of 75-150 mg/day for secondary cardiovascular prevention, 5-=150 mg/day for seconda
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| SUP
1
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| McNeil Consumer & Specialty Pharmaceuticals
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| Vol #:
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| 4
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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
2
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| RS Medical
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| Vol #:
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| 3
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| 2005V-0230
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| Laser Light Show
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| VRA
1
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| HFZ-200 to Crazy Horse Memorial
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| Vol #:
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| 1
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| 2005V-0260
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| Laser Light Show
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| VRA
1
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| HFZ-200 to Fisher Theatrical
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| Vol #:
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| 1
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| 2005V-0287
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| Projector for a Laser Light Show
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