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| Dockets Entered
On April 27, 2005
Table of Contents
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| Docket #
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| Title
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0528
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| Revision of the Requirements for Spore-Forming Microorganisms
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004N-0527
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| Medical Devices; Medical Device Reporting
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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-0015
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| Deny approval of any New Drug Application ( NDA ) for recombinant salmon calcitonin (rsCT ) nasal spray
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| 2005D-0004
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| Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations
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| 2005D-0056
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| Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular a
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 2005P-0162
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| ANDA suitability for Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP, 5 mg/ 0.05 mg/ 5 mL.
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| 2005V-0163
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| Projector for a Laser light Show
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| 2005V-0164
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| Laser Light Show
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7475
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| S and H Wyck
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| Vol #:
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| 319
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 2088
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| L. Kosmela
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| Vol #:
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| 300
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| C 34
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| J. Kloster
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| Vol #:
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| 10
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| 2003N-0528
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| Revision of the Requirements for Spore-Forming Microorganisms
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| C
1
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| Sanofi-Synthelabo, Inc. and Aventis Pharmaceuticals (sanofi aventis)
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| Vol #:
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| 1
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| C 5
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| D. Swanson, R.Ph, M.S., BCNP, CIP
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| Vol #:
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| 2
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| C 165
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| D. Zook
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| Vol #:
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| 39
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| 2004N-0527
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| Medical Devices; Medical Device Reporting
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| C
1
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| Dade Behring Inc.
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| Vol #:
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| 1
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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
16
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| The Family Practice Center
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| Vol #:
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| 2
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| C 17
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| C. Klivans
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| Vol #:
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| 2
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| C 18
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| R. Haug
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| Vol #:
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| 2
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| 2004P-0015
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| Deny approval of any New Drug Application ( NDA ) for recombinant salmon calcitonin (rsCT ) nasal spray
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| RC
1
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| Buc & Beardsley
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| Vol #:
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| 1
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| 2005D-0004
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| Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations
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| C
2
Attachment
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 1
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| C
3
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| AstraZeneca, LP
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| Vol #:
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| 1
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| 2005D-0056
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| Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular a
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| C
1
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| American Society for Reproductive Medicine (ASRM) and Society for Assisted Reproductive Tech (SA
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| Vol #:
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| 1
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| C 1
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| D. Swanson, R.Ph, M.S., BCNP, CIP
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| Vol #:
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| 1
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| C 10
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| R.
Reinhard
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| Vol #:
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| 3
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| C
11
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| Quorum Review, Inc.
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| Vol #:
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| 3
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| C
12
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| Abbott Laboratories
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| Vol #:
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| 3
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| 2005P-0162
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| ANDA suitability for Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP, 5 mg/ 0.05 mg/ 5 mL.
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| ACK
1
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| HFA-305 to Lachman Consultant Services, Inc
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| Vol #:
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| 1
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| 2005V-0163
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| Projector for a Laser light Show
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| ACK
1
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| HFA-305 to Peachstate Audio & Lighting
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| Vol #:
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| 1
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| VAR
1
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| Peachstate Audio & Lighting
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| Vol #:
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| 1
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| 2005V-0164
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| Laser Light Show
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