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| Dockets Entered
On July 1, 2005
Table of Contents
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| Docket #
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| Title
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| 1979P-0418
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| Argon laser
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| 1981P-0001
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| Laser Lumia Projection System
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| 1999V-0555
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| Laser images dual RGB projector
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| 2003V-0124
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| Laser Light Show
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| 2004P-0060
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| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
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| 2004P-0223
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| Whole Grain Descriptive Claims
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| 2004P-0550
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| Determine that AstraZeneca LP's Xylocaine (lidocaine) 10% Oral Spray (NDA 14-394) was voluntarily withdrawn or withheld from sale for reasons other than safety or effficacy
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| 2004P-0557
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| ANDA for a generic version of Efudex Cream(fluorouracil) cream
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| 2005D-0021
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| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
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| 2005D-0047
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| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| 2005D-0103
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| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
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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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| 1979P-0418
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| Argon laser
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| VRA
7
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| HFZ-200 to Brevarde Community College
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| Vol #:
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| 1
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| 1981P-0001
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| Laser Lumia Projection System
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| VRA
12
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| HFZ-200 to Lighting Systems Design, Inc
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| Vol #:
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| 1
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| 1999V-0555
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| Laser images dual RGB projector
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| VRA
3
Attachment
A, B
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| HFZ-200 to Cook Arts, Science, and Technology Center
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| Vol #:
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| 1
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| 2003V-0124
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| Laser Light Show
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| VRA
2
Attachment
A, B
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| HFZ-200 to Universal Studios Florida
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| Vol #:
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| 1
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| 2004P-0060
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| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
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| LET
13
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| HFS-800 to Hogan & Hartson LLP
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| Vol #:
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| 3
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| 2004P-0223
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| Whole Grain Descriptive Claims
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| C
19
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| ConAgra Foods Inc
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| Vol #:
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| 5
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| 2004P-0550
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| Determine that AstraZeneca LP's Xylocaine (lidocaine) 10% Oral Spray (NDA 14-394) was voluntarily withdrawn or withheld from sale for reasons other than safety or effficacy
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| LET
1
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| HFD-5 to Arent Fox PLLC
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| Vol #:
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| 1
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| 2004P-0557
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| ANDA for a generic version of Efudex Cream(fluorouracil) cream
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| LET
1
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| HFD-5 to Valeant Pharmaceuticals International
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| Vol #:
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| 1
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| 2005D-0021
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| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
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| C
6
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| Boehringer Ingelheim Pharmaceuticals Inc
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| Vol #:
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| 1
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| EMC
1
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| PDA
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| Vol #:
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| 1
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| EMC
2
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| Amgen Inc
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| Vol #:
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| 1
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| 2005D-0047
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| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
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| C
5
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| Vaccines Research Advocate
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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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| C
1
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| National Organization for Rare Disorders Inc
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| Vol #:
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| 1
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| C
2
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| Ovation Pharmaceuticals Inc
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| Vol #:
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| 1
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| 2005D-0103
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| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
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| EMC
1
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| R Reinhard, G Broder, T Gibson, D Crawford
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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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| EMC
2
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| American Society of Clinical Oncology
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| Vol #:
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| 1
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| EMC
3
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| Merck & Co. Inc
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| Vol #:
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| 1
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| EMC
4
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| Abbott Global Medical and Scientific Affairs
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| Vol #:
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| 1
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