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| Dockets Entered
On June 2, 2005
Table of Contents
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| Docket #
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| Title
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| 1999F-5522
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| Ionizing radiation /control of Food-borne pathogens safe use
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| 2004N-0559
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| Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
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| 2004P-0520
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| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
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| 2004P-0522
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| Off label drug use for CYTOTEC
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| 2004P-0532
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| Sample distribution by mail or common carrier
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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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| 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-0116
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| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
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| 2005P-0215
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| NUMBER NOT USED
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| 1999F-5522
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| Ionizing radiation /control of Food-borne pathogens safe use
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| C
96
Attachments
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| The Center for Food Safety-Public Citizen
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| Vol #:
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| 10
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| C
54
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| Chocolate Manufacturers Association
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| Vol #:
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| 5
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| 2004N-0559
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| Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
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| C
20
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| Pfizer, Inc.
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| Vol #:
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| 2
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| 2004P-0520
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| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
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| RC
2
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| IVAX Pharmaceuticals, Inc.
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| Vol #:
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| 2
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| 2004P-0522
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| Off label drug use for CYTOTEC
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| LET
1
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| HFD-005 to The Tatia French Memorial Foundation
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| Vol #:
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| 1
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| LET
2
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| HFD-005 to Grateful Doula Services
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| Vol #:
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| 1
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| 2004P-0532
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| Sample distribution by mail or common carrier
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| LET
1
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| HFD-005 to Amit Wohl
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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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| C
8
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| Novo Nordisk
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| Vol #:
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| 1
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| C
9
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| Council on Governmental Relations (COGR)
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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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| C
1
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| Eortc Data Center
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| Vol #:
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| 1
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