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| Dockets Entered
On January 9, 2004
Table of Contents
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| Docket #
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| Title
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| 1995N-0309
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| CGMPs for the Production of Infant Formula
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1998P-1194
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| Withdrawal NADA Approval for Posilac - rBGH
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| 2000P-0685
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| Revise of Yogurt Standards
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2002N-0058
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| Pediculicide Drug Products for OTC Human Use
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| 2002N-0277
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| Bioterrorism; Establishment & Maintenance of Records
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2002P-0489
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| Request Revision of CVM's Bioequivalence Guidelines
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2003D-0504
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| Bundling Multiple Devices in a Single Application; Draft Guidance for Industry and FDA; Availability
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| 2003D-0562
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| Compliance Policy Guide Sec.110.300 b
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2003P-0530
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| Silicone Gel-filled Breast Implants
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| 2004P-0013
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| Review safety of Nutropin Depot Injection, issue direction to Genentech Inc. to add warnings regarding diabetes in their safety literature, and consider amending 21 CFR 314.80(e) Postmarketing studies
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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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| 1995N-0309
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| CGMPs for the Production of Infant Formula
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| C
26
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| American Academy of Pediatrics (AAP)
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| Vol #:
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| 9
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
12202
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| New Chapter, Inc.
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| Vol #:
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| 97
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| LET
12203
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| New Chapter, Inc.
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| Vol #:
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| 97
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| LET
12204
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| New Chapter, Inc.
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| Vol #:
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| 97
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| LET
12205
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| Solstice Medicine Company
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| Vol #:
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| 97
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| LET
12206
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| Solstice Medicine Company
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| Vol #:
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| 97
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| LET
12207
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| Solstice Medicine Company
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| Vol #:
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| 97
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| LET
12208
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| Solstice Medicine Company
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| Vol #:
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| 97
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| LET
12209
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| Solstice Medicine Company
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| Vol #:
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| 97
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| LET
12210
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| Solstice Medicine Company
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| Vol #:
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| 97
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| LET
12211
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| Solstice Medicine Company
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| Vol #:
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| 97
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| LET
12212
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| Solstice Medicine Company
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| Vol #:
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| 97
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| LET
12213
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| Solstice Medicine Company
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| Vol #:
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| 97
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| LET
12214
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| Source Naturals
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| Vol #:
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| 97
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| C
326
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| Sexual Assault and Violence Intervention Program (SAVI)
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| Vol #:
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| 125
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| C
327
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| State of Washington Dept of Health
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| Vol #:
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| 125
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| C 328
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| S. Dubinsky
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| Vol #:
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| 125
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| C
329
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| Operation Outcry: Silent No More
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| Vol #:
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| 125
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| C 330
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| G. Mueller
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| Vol #:
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| 125
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| C 331
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| B. Boone
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| Vol #:
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| 125
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| C 332
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| M. O'Dell
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| Vol #:
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| 125
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| C
333
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| American Academy of Family Physicians
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| Vol #:
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| 125
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| C 334
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| M.L. Palazzo
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| Vol #:
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| 125
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| C
335
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| Form Letter
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| Vol #:
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| 126
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1354
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| C. Cogle
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| Vol #:
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| 233
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| 2002N-0058
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| Pediculicide Drug Products for OTC Human Use
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| SUP
1
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| Supplemental Material
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| Vol #:
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| 1
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| 2002N-0277
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| Bioterrorism; Establishment & Maintenance of Records
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| C
105
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| Comite Interprofessionnel Du Vin de Champagne
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| Vol #:
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| 16
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| C
106
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| Fountain fruit Corporation
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| Vol #:
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| 16
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| C
287
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| Department of Defense (DoD)
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| Vol #:
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| 22
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| 2002P-0489
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| Request Revision of CVM's Bioequivalence Guidelines
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| PDN
1
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| HFC-1 to James H. Schafer, D.V.M.
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| Vol #:
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| 1
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| C
56
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| Form Letters
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| Vol #:
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| 4
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| C
57
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| ECR Pharmaceuticals
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| Vol #:
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| 5
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| C
58
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| T. Kerr
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| Vol #:
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| 5
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| C
59
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| Adams Laboratories, Inc.
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| Vol #:
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| 4
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| C
60
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| Healthpoint, Ltd
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| Vol #:
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| 5
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| 2003D-0504
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| Bundling Multiple Devices in a Single Application; Draft Guidance for Industry and FDA; Availability
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| C
1
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| Olympus America, Inc.
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| Vol #:
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| 1
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| 2003D-0562
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| Compliance Policy Guide Sec.110.300 b
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| C 1
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| M.L. Sotelo
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| Vol #:
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| 1
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| C
7
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| Tru Hearing
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| Vol #:
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| 1
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| 2003P-0530
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| Silicone Gel-filled Breast Implants
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| C
2
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| Action Against Silicone Gel-UK
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| Vol #:
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| 1
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| C
3
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| Secretary Dutch Silicone Support Group,St.SVS
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| Vol #:
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| 1
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| 2004P-0013
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| Review safety of Nutropin Depot Injection, issue direction to Genentech Inc. to add warnings regarding diabetes in their safety literature, and consider amending 21 CFR 314.80(e) Postmarketing studies
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| ACK
1
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| HFA-305 to Consumer
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| Vol #:
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| 1
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| CP
1
Attachment
1, 2, 3,
4, 5,
6, 7,
8, 9,
10, 11,
12, 13
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| Consumer
|
| Vol #:
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| 1
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| 2004P-0015
|
| Deny approval of any New Drug Application ( NDA ) for recombinant salmon calcitonin (rsCT ) nasal spray
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| ACK
1
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| HFA-305 to Buc & Beardsley
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| Vol #:
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| 1
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| CP
1
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| Buc & Beardsley
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| Vol #:
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| 1
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