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| Dockets Entered
On October 23, 2003
Table of Contents
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| Docket #
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| Title
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| 1978N-0036L
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| OTC Laxative
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2000N-1484
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| Safety Reporting Requirements Human Drug/Biological Products
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| 2000V-1287
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| Laser Light Show
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| 2001P-0323
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| Not rely on non-public filings to approve an innovator NDA;
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| 2001V-0393
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| Laser Light Show
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| 2002N-0475
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| Financial Relationships & Interest in Research Involving Hum
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| 2002P-0447
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| Immediately revoke its acceptance for NDA 21-435 for amlodin
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| 2003D-0465
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| Guidance for Industry on Providing Regulatory Submissions in Electronic Format b
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| 2003D-0466
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| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on b
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| 2003N-0269
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation
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| 2003N-0455
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| Training Program for Regulatory Project Managers; Information Available to Industry
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| 2003V-0489
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| Laser Light Show
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| 1978N-0036L
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| OTC Laxative
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| NPR
10
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| FDA
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| Vol #:
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| 121
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7101
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| Rosemary Foyt
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| Vol #:
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| 301
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| C 7102
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| Florence Francis
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| Vol #:
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| 301
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| C 7103
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| Eleanor Rivette
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| Vol #:
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| 301
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| C 7104
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| John J. Gabriel
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| Vol #:
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| 301
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| C 7105
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| Mary-Jane Newborn
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| Vol #:
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| 301
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| C 7106
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| Susannah L. Biggs
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| Vol #:
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| 301
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| C 7107
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| Angela Magnano
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| Vol #:
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| 301
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| C 7108
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| Bernice Dobrosz
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| Vol #:
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| 301
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| C 7109
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| Cindy Ekleberry
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| Vol #:
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| 301
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| C 7110
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| William L. Duffey
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| Vol #:
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| 301
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| C 7111
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| Robert Clerico
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| Vol #:
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| 301
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| C 7112
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| J. Anzelone
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| Vol #:
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| 301
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| C 7113
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| David B. Shalek
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| Vol #:
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| 301
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| C 7114
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| Teresann Furlan
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| Vol #:
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| 301
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| C 7115
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| L.V. Taylor
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| Vol #:
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| 301
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| C 7116
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| Karen C. Dipietro
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| Vol #:
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| 301
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| C 7117
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| Albert Dunn Jr.
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| Vol #:
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| 301
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| C 7155
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| Cynthia K. Schwartz
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| Vol #:
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| 30230
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| C 7156
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| Dr. Aimee K. Lubell
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| Vol #:
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| 302
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| C 7157
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| Brenda Shoss
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| Vol #:
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| 302
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| C 7158
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| No signature
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| Vol #:
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| 302
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| C 7159
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| Laura A. Schweinberger
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| Vol #:
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| 302
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| C 7160
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| Marian F. McAleenan
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| Vol #:
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| 302
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| C 7161
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| Ken Seibert
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| Vol #:
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| 302
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| C 7162
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| Nancy Clough
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| Vol #:
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| 302
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| C 7163
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| Karen Harendza
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| Vol #:
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| 302
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| C 7164
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| Doris Hughes
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| Vol #:
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| 302
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| 2000N-1484
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| Safety Reporting Requirements Human Drug/Biological Products
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| C
47
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| Aids Treatment Activists Coalition (ATAC)
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| Vol #:
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| 6
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| C
48
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| Assn of Clinical Research Organizations (ACRO)
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| Vol #:
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| 6
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| C
49
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| The Cleveland Clinic Foundation
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| Vol #:
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| 6
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| C
50
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| Plasma Protein Therapeutics Assn (PPTA)
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| Vol #:
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| 6
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| C
51
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| Bristol-Myers Squibb (BMS)
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| Vol #:
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| 6
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| LET
1
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| Bristol-Myers Squibb (BMS)
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| Vol #:
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| 6
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| 2000V-1287
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| Laser Light Show
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| VRA
2
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| HFZ-300 to Main Light Industries, Inc.
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| Vol #:
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| 1
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| 2001P-0323
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| Not rely on non-public filings to approve an innovator NDA;
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| PDN
1
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| HFD-1 to Pfizer Inc. & Pharmacia Corp.
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| Vol #:
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| 1
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| 2001V-0393
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| Laser Light Show
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| VRA
2
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| HFZ-300 to Ace Mitchell Bowler's Mart
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| Vol #:
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| 1
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| 2002N-0475
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| Financial Relationships & Interest in Research Involving Hum
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| LET
1
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| Bristol-Myers Squibb (BMS)
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| Vol #:
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| 2
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| 2002P-0447
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| Immediately revoke its acceptance for NDA 21-435 for amlodin
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| PDN
1
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| HFD-1 to Pfizer Inc.
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| Vol #:
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| 1
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| 2003D-0465
|
| Guidance for Industry on Providing Regulatory Submissions in Electronic Format b
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|
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2003D-0466
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| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on b
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|
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|
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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| | | | | | | | |
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| NAD
1
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| FDA
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| Vol #:
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| 1
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|
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| 2003D-0478
|
| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
|
|
|
|
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
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|
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| HER
1
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| Korangy Radiology Associates, P.A.
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| Vol #:
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| 1
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| 2003N-0269
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation
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|
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|
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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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| 2003N-0455
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| Training Program for Regulatory Project Managers; Information Available to Industry
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2003V-0489
|
| Laser Light Show
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| ACK 1
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| HFA-305 to Discovery Beach Restaurant & Club Inc.
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| Vol #:
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| 1
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| VAR
1
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| Discovery Beach Restaurant & Club Inc.
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| Vol #:
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| 1
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