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| Dockets Entered
On July 30, 2004
Table of Contents
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| Docket #
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| Title
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| 1979P-0055
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| Avi Laserlumia
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1997V-0006
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| Laser Light Show
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001V-0158
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| Laser Light show
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| 2002N-0275
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| Bioterrorism Preparedness; Administrative Detention
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2003N-0308
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| CIVIL MONEY PENALTIES HEARINGS; MAXIMUM PENALTY AMOUNTS AND Compliance with the FEDERAL CIVIL PENALTIES Inflation Adjustment Act
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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| 2004D-0118
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| International Conference on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004N-0181
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| Critical Path Initiative
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| 2004N-0184
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| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
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| 2004N-0254
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| Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004N-0267
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| Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications
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| 2004N-0286
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| Withdrawal of Six Guidances on the Clinical Evaluation of or Requirements for Approval of Certain Classes of Drugs
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| 2004N-0330
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| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
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| 2004N-0337
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| Subpart D IRB Referral, Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder; A Functional Magnetic Resonance Study.
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| 2004P-0037
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| 513(f) Reclassification Petition for TV-TIP Sound Amplifier
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| 2004P-0055
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| Issue a written opinion stating that Bio-Rad's longstanding practice, previously accepted by the agency, of developing unified, truthful labeling for domestic and international sales of its control pr
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| 2004P-0164
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| Exemption from the medical devices tracking requirements for Heartstream automated external defibrillators
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| 2004P-0340
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| action on regulation of generic transdermal fentanyl delivery system, and new product approvals for transdermal fentanyl products
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| 2004S-0270
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| Notice Announcing Publication of the Report to Congress Entitled Plan for the Transfer of Responsibility for Medicare Appeals and Soliciting Comments
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| 2004V-0284
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| Projector for a laser light show
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| 1979P-0055
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| Avi Laserlumia
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| VRA
13
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| HFZ-300 to Audio Visual Imagineering, Inc.
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| Vol #:
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| 1
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
14137
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| Integrative Therapeutics Inc.
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| Vol #:
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| 122
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| LET
14138
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| Shaklee Corporation
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| Vol #:
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| 122
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| LET
14139
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| Wyeth Consumer Healthcare, a division of Wyeth
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| Vol #:
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| 122
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| | | | | | | | |
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| 1997V-0006
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| Laser Light Show
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| VRA
2
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| HFZ-300 to Lars Lighting
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| Vol #:
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| 1
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| C 43
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| P. Goodman
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| Vol #:
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| 2
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| C 44
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| S. Robles
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| Vol #:
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| 2
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| C 45
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| C. Bingham
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| Vol #:
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| 2
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| C 46
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| E. Saeva
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| Vol #:
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| 2
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| C 47
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| L. Staples
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| Vol #:
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| 2
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| C 48
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| V. Regine
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| Vol #:
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| 2
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 420
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| Center for Veterinary Medicine
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| Vol #:
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| 425
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| EXB 421
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| Center for Veterinary Medicine
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| Vol #:
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| 425
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| EXB 422
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| Center for Veterinary Medicine
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| Vol #:
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| 425
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| EXB 423
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| Center for Veterinary Medicine
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| Vol #:
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| 425
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| EXB 424
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| Center for Veterinary Medicine
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| Vol #:
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| 425
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| EXB 425
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| Center for Veterinary Medicine
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| Vol #:
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| 425
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| EXB 426
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| Center for Veterinary Medicine
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| Vol #:
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| 425
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| EXB 427
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| Center for Veterinary Medicine
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| Vol #:
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| 425
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| EXB 428
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| Center for Veterinary Medicine
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| Vol #:
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| 425
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| EXB 429
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| Center for Veterinary Medicine
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| Vol #:
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| 426
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| EXB 430
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| Center for Veterinary Medicine
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| Vol #:
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| 426
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| EXB 431
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| Center for Veterinary Medicine
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| Vol #:
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| 426
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| EXB 432
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| Center for Veterinary Medicine
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| Vol #:
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| 426
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| EXB 433
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| Center for Veterinary Medicine
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| Vol #:
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| 426
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| EXB 434
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| Center for Veterinary Medicine
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| Vol #:
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| 426
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| EXB 435
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| Center for Veterinary Medicine
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| Vol #:
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| 426
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| EXB 436
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| Center for Veterinary Medicine
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| Vol #:
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| 426
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| EXB 437
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| Center for Veterinary Medicine
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| Vol #:
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| 426
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| EXB 438
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| Center for Veterinary Medicine
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| Vol #:
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| 426
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| EXB 439
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| Center for Veterinary Medicine
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| Vol #:
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| 426
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| EXB 440
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| Center for Veterinary Medicine
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| Vol #:
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| 426
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| EXB 441
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| Center for Veterinary Medicine
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| Vol #:
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| 426
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| EXB 442
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| Center for Veterinary Medicine
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| Vol #:
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| 426
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| EXB 443
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| Center for Veterinary Medicine
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| Vol #:
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| 426
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| | | | | | | | |
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|
|
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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|
|
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| LST
17
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| Downlink Attendance Sheet
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| Vol #:
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| 28
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| LST
18
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| Bioterrorism Act Seminar Attendance Sheet
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| Vol #:
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| 28
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| LST
19
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| Bioterrorism Act Seminar Attendance Sheet
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| Vol #:
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| 28
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|
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| LST
20
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| List of FDA Domestic Outreach Meetings
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| Vol #:
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| 28
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| TR
8
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| Meeting Held in Denver Colorado on March 2, 2004
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| Vol #:
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| 29
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| TR
9
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| Meeting Held in Fresno California on March 4, 2004
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| Vol #:
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| 30
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| TR
10
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| Meeting held in El Paso Texas on March 9, 2004
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| Vol #:
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| 31
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| TR
11
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| Meeting held in Salt Lake City, Utah on March 11, 2004
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| Vol #:
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| 32
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| TR
12
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| Meeting held in Kansas City Missouri on March 16, 2004
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| Vol #:
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| 33
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| TR
13
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| Meeting held in New Orleans, Louisiana on March 18, 2004
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| Vol #:
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| 34
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| TR
14
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| Meeting held in Philadelphia, Pennsylvania on March 24, 2004
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| Vol #:
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| 35
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| TR
15
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| Meeting held in Boston, Massachusetts on April 1, 2004
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| Vol #:
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| 36
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|
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| LST
17
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| Downlink Attendence Sheet
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| Vol #:
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| 30
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|
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| LST
18
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| Bioterrorism Act Seminar Attendance Sheet
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| Vol #:
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| 30
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| LST
19
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| Bioterrorism Act Seminar Attendance Sheet
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| Vol #:
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| 30
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|
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| LST
20
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| List of FDA Domestic Outreach Meetings
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| Vol #:
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| 30
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|
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| TR
7
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| Meeting held in Denver, Colorado on March 2, 2004
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| Vol #:
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| 31
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|
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| TR
8
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| Meeting held in Fresno, California on March 4, 2004
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| Vol #:
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| 32
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| TR
9
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| Meeting held in El Paso, Texas on March 9, 2004
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| Vol #:
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| 33
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| TR
10
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| Meeting held in Salt Lake City, Utah on March 11, 2004
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| Vol #:
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| 34
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| TR
11
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| Meeting held in Kansas City, Missouri on March 16, 2004
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| Vol #:
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| 35
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| TR
12
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| Meeting held in New Orleans, Louisiana on March 18, 2004
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| Vol #:
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| 36
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| TR
13
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| Meeting held in Philadelphia, Pennsylvania on March 24, 2004
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| Vol #:
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| 37
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| TR
14
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| Meeting held in Boston, Massachusetts on April 1, 2004
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| Vol #:
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| 38
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|
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| 2003N-0308
|
| CIVIL MONEY PENALTIES HEARINGS; MAXIMUM PENALTY AMOUNTS AND Compliance with the FEDERAL CIVIL PENALTIES Inflation Adjustment Act
|
|
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
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| 1
|
|
|
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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|
|
|
|
| LET
1
|
| HFZ-1 to Committee for Truth in Psychiatry
|
| Vol #:
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| 2
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|
|
|
|
| 2004D-0118
|
| International Conference on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
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|
|
|
|
| C
3
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| Millennium Pharmaceuticals, Inc.
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| Vol #:
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| 1
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|
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| 2004N-0081
|
| BSE Risk Materials in Foods and Cosmetics
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|
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|
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| SUP 1
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| BSE Stakeholders Conference Calls
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| Vol #:
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| 7
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|
| | | | | | | | |
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| 2004N-0181
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| Critical Path Initiative
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| C 6
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| S and P Bloom
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| Vol #:
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| 1
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| C
7
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| Assn of Clinical Research Organizations (ACRO)
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| Vol #:
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| 1
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| C 8
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| E. Alter
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| Vol #:
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| 1
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| C 9
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| S and P Bllom
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| Vol #:
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| 1
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| C 10
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| K and M Shore
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| Vol #:
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| 1
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| C
11
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| Chiron Corporation
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| Vol #:
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| 1
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| C 12
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| J. Donalty
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| Vol #:
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| 1
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| C 13
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| M. Jans, JD
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| Vol #:
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| 1
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| C
14
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| Bristol-Myers Squibb Company (BMS)
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| Vol #:
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| 1
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|
|
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| 2004N-0184
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| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
|
|
|
|
|
| C
5
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| Phillips Foods, Inc.
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| Vol #:
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| 1
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| C
6
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| National Nutritional Foods Assn (NNFA)
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| Vol #:
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| 1
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| C
7
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| National Food Processors Assn (NFPA)
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| Vol #:
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| 1
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|
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| 2004N-0254
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| Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children
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|
|
|
|
| C 3
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| L. Latson, MD
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| Vol #:
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| 1
|
|
|
|
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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|
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|
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| C 2
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| M. Fish
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| Vol #:
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| 1
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| C 3
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| Form Letters
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| Vol #:
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| 2
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| C 4
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| Form Letters
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| Vol #:
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| 3
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| C 5
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| Form Letters
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| Vol #:
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| 4
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|
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| C 6
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| Form Letters
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| Vol #:
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| 5
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|
|
|
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| 2004N-0267
|
| Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications
|
|
|
|
|
| NPR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0286
|
| Withdrawal of Six Guidances on the Clinical Evaluation of or Requirements for Approval of Certain Classes of Drugs
|
|
|
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0330
|
| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
|
|
|
|
|
| NM
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0337
|
| Subpart D IRB Referral, Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder; A Functional Magnetic Resonance Study.
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0037
|
| 513(f) Reclassification Petition for TV-TIP Sound Amplifier
|
|
|
|
|
| PDN
1
|
| HFZ-1 to Etymotic Research, Inc.
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
|
|
|
| 2004P-0055
|
| Issue a written opinion stating that Bio-Rad's longstanding practice, previously accepted by the agency, of developing unified, truthful labeling for domestic and international sales of its control pr
|
|
|
|
|
|
|
|
|
| LET
1
|
| HFZ-1 to Bio-Rad Laboratories
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004P-0164
|
| Exemption from the medical devices tracking requirements for Heartstream automated external defibrillators
|
|
|
|
|
| LET
1
|
| HFZ-300 to Philips Medical Systems
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004P-0340
|
| action on regulation of generic transdermal fentanyl delivery system, and new product approvals for transdermal fentanyl products
|
|
|
|
|
| ACK
1
|
| VA Palo Alto Health Care System
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
Attachments
|
| VA Palo Alto Health Care System
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004S-0270
|
| Notice Announcing Publication of the Report to Congress Entitled Plan for the Transfer of Responsibility for Medicare Appeals and Soliciting Comments
|
|
|
| C
1
|
| Center for Medicare Advocacy, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004V-0284
|
| Projector for a laser light show
|
|
|
|
|
| VRA
1
|
| HFZ-300 to Jose Ayala
|
| Vol #:
|
| 1
|
|
