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| Dockets Entered
On November 10, 2003
Table of Contents
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| Docket #
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| Title
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| |
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| 1999N-1852
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| Status reports/postmarketing studies-human drugs&biological
|
| |
|
|
| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
| |
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
| |
|
|
| 2002P-0506
|
| Was Wydase (Hyaluronidase) Inj. withdrawn for Safety Reasons
|
| |
|
|
| 2003D-0380
|
| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
|
| |
|
|
| 2003D-0382
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| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
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| |
|
|
| 2003D-0478
|
| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
|
| |
|
|
| 2003M-0157
|
| PMA, Medtronic Activa Dystonia Therapy, H020007
|
| |
|
|
| 2003M-0173
|
| PMA Healthtronics OssaTron, P990086/S003
|
| |
|
|
| 2003M-0174
|
| TECHNOLAS 217A Excimer Laser System, P990027/S004
|
| |
|
|
| 2003M-0175
|
| PMA Essure System, P020014
|
| |
|
|
| 2003M-0189
|
| P010055 - ProstaLund? CoreTherm? System Microwave Thermotherapy for BPH, Approved 12/23/02
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| |
|
|
| 2003M-0190
|
| P980035/S013 - Medtronic AT500 DDDRP Pacing System (Model AT501) and Model 9968 Software, Approved 3/27/03
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| |
|
|
| 2003M-0240
|
| P990069 - EPMed Systems, Inc., ALERTB. System (ALERTB. Catheter, ALERTB. Interface Cable, and ALERTB. Companionb
|
| |
|
|
| 2003M-0241
|
| P020028 - Series 50 XMO (Model M1350C) Fetal/Maternal Monitor System with Integrated Fetal Oxygen Saturation Monitoring
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| |
|
|
| 2003M-0242
|
| Zenith AAA Endovascular Graft and H&L One-Shot' Introduction System, P020018
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| |
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| 2003M-0262
|
| PMA Immulite HBsAG Confirmatory Kit, P010050
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| |
|
|
| 2003M-0271
|
| P010051 - IMMULITEB. Anti-HBc and IMMULITEB. 2000 Anti-HBc, Approved 6/24/02
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| |
|
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| 2003M-0272
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| P010053 - IMMULITEB. Anti-HBc IgM and IMMULITEB. 2000 Anti-HBc IgM, Approved 7/26/02
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| |
|
|
| 2003M-0287
|
| P010052 - IMMULITEB. Anti-HBs and IMMULITEB. 2000 Anti-HBs, Approved 7/22/02
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| |
|
|
| 2003M-0320
|
| Premarket Approval, FX miniRAIL, Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter,P020037
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| |
|
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| 2003M-0332
|
| P010001, Ceramic TRANSCEND Hip Articulation System, Approved 2/3/03
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| |
|
|
| 2003M-0333
|
| STAR S4 ActiveTrak Excimer Laser System and WaveScan WaveFront System
|
| |
|
|
| 2003M-0337
|
| P000013 - Osteonics ABC System and Trident System
|
| |
|
|
| 2003M-0339
|
| P020002 - ThinPrep Imaging System
|
| |
|
|
| 2003M-0343
|
| Premarket Approval, P020052 - Response CV Catheter System
|
| |
|
|
| 2003M-0352
|
| PMA P020049, ProCol Vascular Bioprosthesis
|
| |
|
|
| 2003N-0017
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| Risk Management Programs on the Practice of Pharmacy
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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
|
| |
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
| |
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
| |
|
|
| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| 2003P-0021
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| Withdrawal of Wydase, Hyaluronidase Injection
|
| |
|
|
| 2003P-0479
|
| Allow importation of Canadian versions of drugs that are approved to the United States
|
| |
|
|
| 2003P-0520
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| Laser Light Show
|
| |
|
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| 2003V-0521
|
| Laser Light Show
|
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|
|
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|
|
|
|
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|
|
|
|
|
|
| 1995N-0304
|
| Ephedrine Alkaloids:
Reports of Adverse Events; Availability
|
|
|
|
|
| EMC 936
|
| No signature
|
| Vol #:
|
| 375
|
|
|
|
|
| EMC 937
|
| Audrey
|
| Vol #:
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| 375
|
|
|
|
|
| EMC 938
|
| Kathy Hadam
|
| Vol #:
|
| 375
|
|
|
|
|
| EMC 939
|
| Dawn Ondo
|
| Vol #:
|
| 375
|
|
|
|
|
| EMC 940
|
| Mark A. Dreifke
|
| Vol #:
|
| 375
|
|
|
|
|
| EMC 941
|
| No signature
|
| Vol #:
|
| 375
|
|
|
|
|
| 1999N-1852
|
| Status reports/postmarketing
studies-human drugs&biological
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1999N-4282
|
| Biotechnology in
the Year 2000 and Beyond; Public Meetings
|
|
|
|
|
| EMC 4076
|
| Martha Herrero
|
| Vol #:
|
| 514
|
|
|
|
|
| EMC 4077
|
| Audrey Minich
|
| Vol #:
|
| 514
|
|
|
|
|
| 1999P-2630
|
| Establish a Daily
Value for "added sugars"
|
|
|
|
|
| EMC 627
|
| Paul Borokhov
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 628
|
| Shannon Rogers
|
| Vol #:
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| 32
|
|
|
|
|
| EMC 629
|
| Brett Brodie
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 630
|
| Gena McKinley
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 631
|
| Alissa Green
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 632
|
| Georgann Hallenbrook
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 633
|
| Cathy Blais
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 634
|
| Elaine Hillen
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 635
|
| Felix Aguilar, MD
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 636
|
| William Gardner
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 637
|
| Dale Krewson
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 638
|
| Gretchen Ross
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 639
|
| Diane Farina
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 640
|
| Dr. Jim Hanson
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 641
|
| John Cleveland
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 642
|
| Jessica Cousino
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 643
|
| Mr. Denham
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 644
|
| Daniel Barnett
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 645
|
| Mary Larson-Edwards
|
| Vol #:
|
| 32
|
|
|
|
|
| EMC 646
|
| Lori Tubbs
|
| Vol #:
|
| 32
|
|
|
|
|
| 2001D-0583
|
| Food Security Guidance
|
|
| | | | | | | | |
|
| |
|
| EC 17
|
| Adinolfi, Thomas
|
| Vol #:
|
| 1
|
| |
|
|
| EC 18
|
| Slitt, Laura
|
| Vol #:
|
| 1
|
|
| |
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
| |
|
|
| EC 271
|
| SANCHEZ, ARTEMISA BLANCA
|
| Vol #:
|
| 15
|
| |
|
|
| EC 273
|
| Tankersley, Frank
|
| Vol #:
|
| 15
|
| |
|
|
| EC 276
|
| ZHOU, LINGUANG
|
| Vol #:
|
| 15
|
| |
|
|
| EC 277
|
| zhou, linguang
|
| Vol #:
|
| 15
|
| |
|
|
| EC 278
|
| Gustafson, Beth
|
| Vol #:
|
| 15
|
| |
|
|
| EC 279
|
| Baglieri, George
|
| Vol #:
|
| 15
|
| |
|
|
| EC 282
|
| NGUYEN, BA TONG
|
| Vol #:
|
| 15
|
| |
|
|
| EC 283
|
| Stecker, Gail
|
| Vol #:
|
| 15
|
| |
|
|
| EC 284
|
| NGUYEN, GIANG CHAU
|
| Vol #:
|
| 15
|
| |
|
|
| EC 288
|
| Haugen, Patrick
|
| Vol #:
|
| 15
|
| |
|
|
| EC 289
|
| Farren, Glenn
|
| Vol #:
|
| 15
|
| |
|
|
| EC 290
|
| Duffy, Pete
|
| Vol #:
|
| 15
|
| |
|
|
| EC 291
|
| CHENG, KENNY
|
| Vol #:
|
| 15
|
| |
|
|
| EC 292
|
| Mello, Paulo
|
| Vol #:
|
| 15
|
| |
|
|
| EC 293
|
| Thurber, Pamela
|
| Vol #:
|
| 15
|
| |
|
|
| EC 294
|
| OTERO, CARLOS
|
| Vol #:
|
| 15
|
| |
|
|
| EC 296
|
| Donner-Abreu, Marcia
|
| Vol #:
|
| 15
|
| |
|
|
| EC 297
|
| Donner-Abreu, Marcia
|
| Vol #:
|
| 15
|
| |
|
|
| EC 298
|
| Savitz, Paige
|
| Vol #:
|
| 15
|
| |
|
|
| EC 300
|
| Johnston, Ralph
|
| Vol #:
|
| 15
|
| |
|
|
| EC 303
|
| HIREBET, GHANASHYAM
|
| Vol #:
|
| 15
|
| |
|
|
| EC 305
|
| HIREBET, GHANASHYAM
|
| Vol #:
|
| 15
|
| |
|
|
| EC 307
|
| souad, ROUANI
|
| Vol #:
|
| 15
|
| |
|
|
| EC 308
|
| souad, ROUANI
|
| Vol #:
|
| 15
|
| |
|
|
| EC 309
|
| Faurby, Vibeke
|
| Vol #:
|
| 15
|
| |
|
|
| EC 310
|
| Mesrobian, Peter
|
| Vol #:
|
| 15
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| EC 309
|
| McGraw, Jonathan
|
| Vol #:
|
| 17
|
| |
|
|
| EC 310
|
| COOKSON, DAVID
|
| Vol #:
|
| 17
|
| |
|
|
| EC 311
|
| mcgraw, jon
|
| Vol #:
|
| 17
|
| |
|
|
| EC 312
|
| Kerpan, Louis
|
| Vol #:
|
| 17
|
| |
|
|
| EC 313
|
| Grasso, AJ
|
| Vol #:
|
| 17
|
|
| | | | | | | | |
|
|
|
| EC 314
|
| Faurby, Vibeke
|
| Vol #:
|
| 17
|
| |
|
|
| EC 315
|
| gordon, donald
|
| Vol #:
|
| 17
|
| |
|
|
| EC 316
|
| Ellsworth, Tanya
|
| Vol #:
|
| 17
|
| |
|
|
| 2002P-0506
|
| Was Wydase (Hyaluronidase) Inj. withdrawn for Safety Reasons
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0163
|
| Blood Product Safety in Cases of Suspected SARS,Severe Acute
|
| |
|
|
| EC 4
|
| Slitt, Laura
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0165
|
| Current Good Manufacturing Practices for Medical Gases
|
| |
|
|
| EC 2
|
| Waters, Ronald
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0195
|
| Draft Guidance for Industry on Necessity of the Use of Food Product Categories in Registration of Food Facilities
|
| |
|
|
| EC 16
|
| McCarter, J.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0290
|
| Compounding of Drugs for Use in Animals Compliance Policy Guide
|
| |
|
|
| EC 5
|
| Adams, Janice
|
| Vol #:
|
| 1
|
| |
|
|
| EC 6
|
| Dowse, Anita
|
| Vol #:
|
| 1
|
| |
|
|
| EC 7
|
| Crawford, Nancy
|
| Vol #:
|
| 1
|
| |
|
|
| EC 9
|
| Caruso, Diana
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0380
|
| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
|
| |
|
|
| EC 1
|
| Anderson, Nathan
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| Materna, Joan
|
| Vol #:
|
| 1
|
| |
|
|
| EC 3
|
| Stoedter, William
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
7
|
| Merck & Co., Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
8
|
| International Assn for Pharmaceutical Science and Technology (PDA)
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
9
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
10
|
| DSM Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0382
|
| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
|
| |
|
|
| EC 4
|
| Dafforn, Christopher
|
| Vol #:
|
| 3
|
| |
|
|
| EC 5
|
| Anderson, Nathan
|
| Vol #:
|
| 3
|
| |
|
|
| EC 6
|
| Anderson, Nathan
|
| Vol #:
|
| 3
|
| |
|
|
| EC 8
|
| Reh, Robert
|
| Vol #:
|
| 3
|
| |
|
|
| EC 10
|
| Reh, Robert
|
| Vol #:
|
| 3
|
| |
|
|
| EC 11
|
| Gilmour, Nicolas M
|
| Vol #:
|
| 3
|
| |
|
|
| EC 12
|
| Gilmour, Nicolas M
|
| Vol #:
|
| 3
|
|
| | | | | | | | |
|
| |
|
| EC 13
|
| Hokinson, Ann
|
| Vol #:
|
| 3
|
| |
|
|
| EC 14
|
| Hokinson, Ann
|
| Vol #:
|
| 3
|
| |
|
|
| EC 15
|
| Hokinson, Ann
|
| Vol #:
|
| 3
|
| |
|
|
| EC 16
|
| Phelan, Maurice
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
20
|
| La Calhene
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
21
|
| Merck & Co., Inc. (Merck)
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
22
|
| Generic Pharmaceutical Assn (GPhA)
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
23
|
| Quality Systems Consulting, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
24
|
| Bosch Packaging Technology
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 25
|
| Irving J. Pflug
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 26
|
| Irving J. Pflug
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
27
|
| Accugenix
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
28
|
| Advanced Barrier Concepts, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
29
|
| Advanced Barrier Concepts, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 30
|
| Mike J. Wikol
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 31
|
| Bill Whyte
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
32
|
| Parenteral Society
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
33
|
| Robert BOSCH GmbH
|
| Vol #:
|
| 3
|
| |
|
|
| 2003D-0385
|
| Guidance for Industry: Comparability Protocols b
|
| |
|
|
| EC 1
|
| Anderson, Nathan
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0434
|
| Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications: Effect on FDA Review Clock and Performance Assessment; Availability
|
| |
|
|
| EC 2
|
| mayo, serena
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0478
|
| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
|
| |
|
|
| EC 3
|
| shuller, kathleen
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 11
|
| Connie Quirk
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 12
|
| Charlotte Melson
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0157
|
| PMA, Medtronic Activa Dystonia Therapy, H020007
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0173
|
| PMA Healthtronics OssaTron, P990086/S003
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0174
|
| TECHNOLAS 217A Excimer Laser System, P990027/S004
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0175
|
| PMA Essure System, P020014
|
|
| | | | | | | | |
|
| |
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0189
|
| P010055 - ProstaLund? CoreTherm? System Microwave Thermotherapy for BPH, Approved 12/23/02
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0190
|
| P980035/S013 - Medtronic AT500 DDDRP Pacing System (Model AT501) and Model 9968 Software, Approved 3/27/03
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0240
|
| P990069 - EPMed Systems, Inc., ALERTB. System (ALERTB. Catheter, ALERTB. Interface Cable, and ALERTB. Companionb
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0241
|
| P020028 - Series 50 XMO (Model M1350C) Fetal/Maternal Monitor System with Integrated Fetal Oxygen Saturation Monitoring
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0242
|
| Zenith AAA Endovascular Graft and H&L One-Shot' Introduction System, P020018
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0262
|
| PMA Immulite HBsAG Confirmatory Kit, P010050
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0271
|
| P010051 - IMMULITEB. Anti-HBc and IMMULITEB. 2000 Anti-HBc, Approved 6/24/02
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0272
|
| P010053 - IMMULITEB. Anti-HBc IgM and IMMULITEB. 2000 Anti-HBc IgM, Approved 7/26/02
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0287
|
| P010052 - IMMULITEB. Anti-HBs and IMMULITEB. 2000 Anti-HBs, Approved 7/22/02
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0320
|
| Premarket Approval, FX miniRAIL, Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter,P020037
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0332
|
| P010001, Ceramic TRANSCEND Hip Articulation System, Approved 2/3/03
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0333
|
| STAR S4 ActiveTrak Excimer Laser System and WaveScan WaveFront System
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0337
|
| P000013 - Osteonics ABC System and Trident System
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0339
|
| P020002 - ThinPrep Imaging System
|
|
| | | | | | | | |
|
| |
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0343
|
| Premarket Approval, P020052 - Response CV Catheter System
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0352
|
| PMA P020049, ProCol Vascular Bioprosthesis
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0017
|
| Risk Management Programs on the Practice of Pharmacy
|
| |
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0069
|
| FDA Task Force on Consumer Health Info for Better Nutrition
|
| |
|
|
| EC 86
|
| Craig, Steven
|
| Vol #:
|
| 1
|
| |
|
|
| EC 87
|
| Early, Dan
|
| Vol #:
|
| 1
|
| |
|
|
| EC 88
|
| O'Mara, Ruth
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC
103
|
| BanTransFat
|
| Vol #:
|
| 3
|
| |
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
| |
|
|
| EMC
3
|
| National Grain and Feed Assn (NGFA)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0338
|
| Obesity
|
| |
|
|
| EC 32
|
| Wagner, Kent
|
| Vol #:
|
| 6
|
| |
|
|
| EC 36
|
| Hannan, Beth
|
| Vol #:
|
| 6
|
| |
|
|
| EC 37
|
| steele, shirley
|
| Vol #:
|
| 6
|
| |
|
|
| EC 38
|
| Hill, Melissa
|
| Vol #:
|
| 6
|
| |
|
|
| EC 39
|
| Preast, Terri
|
| Vol #:
|
| 6
|
| |
|
|
| EC 41
|
| Ruhl, Janet
|
| Vol #:
|
| 6
|
| |
|
|
| EC 42
|
| Schade, Patricia
|
| Vol #:
|
| 6
|
| |
|
|
| EC 43
|
| Kizer, Janyne
|
| Vol #:
|
| 6
|
| |
|
|
| EC 44
|
| Schwartz, Toby
|
| Vol #:
|
| 6
|
| |
|
|
| EC 45
|
| Walters, Kimberly
|
| Vol #:
|
| 6
|
| |
|
|
| EC 46
|
| Muray, Kathleen
|
| Vol #:
|
| 6
|
| |
|
|
| EC 48
|
| Turpin, Lisa
|
| Vol #:
|
| 6
|
| |
|
|
| EC 49
|
| Rodenburg, Mark
|
| Vol #:
|
| 6
|
| |
|
|
| EC 50
|
| Anandan, Tarek
|
| Vol #:
|
| 6
|
| |
|
|
| EC 51
|
| McCaliister, AnnMarie
|
| Vol #:
|
| 6
|
|
| | | | | | | | |
|
| |
|
| EC 52
|
| Blackburn, George
|
| Vol #:
|
| 6
|
| |
|
|
| EC 54
|
| Herb, Ellyn
|
| Vol #:
|
| 6
|
| |
|
|
| EC 55
|
| Smith, Tiffany
|
| Vol #:
|
| 6
|
| |
|
|
| EC 57
|
| lee, gavin
|
| Vol #:
|
| 6
|
| |
|
|
| EC 59
|
| Frank, Arthur
|
| Vol #:
|
| 6
|
| |
|
|
| EC 60
|
| Wolf, Mary-Anne
|
| Vol #:
|
| 6
|
| |
|
|
| 2003N-0346
|
| Food Labeling: Ingredient Labeling of Dietary Supplements That Contain Botanicals
|
| |
|
|
| EC 2
|
| Taylor, Leslie
|
| Vol #:
|
| 4
|
| |
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
| |
|
|
| EC 12
|
| Swan, Richard
|
| Vol #:
|
| 5
|
| |
|
|
| EC 14
|
| White, Ed
|
| Vol #:
|
| 5
|
| |
|
|
| EC 15
|
| Austin, Timothy
|
| Vol #:
|
| 5
|
| |
|
|
| EC 16
|
| Yu, Lea
|
| Vol #:
|
| 5
|
| |
|
|
| EC 19
|
| Natan, Michael
|
| Vol #:
|
| 5
|
| |
|
|
| EC 20
|
| Schmidt, Patrick
|
| Vol #:
|
| 5
|
| |
|
|
| EC 21
|
| Sandor, Robert
|
| Vol #:
|
| 5
|
| |
|
|
| EC 22
|
| Samony, John
|
| Vol #:
|
| 5
|
| |
|
|
| EC 23
|
| Movens, Daniel
|
| Vol #:
|
| 1
|
| |
|
|
| EC 24
|
| Murphy, Deborah
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 31
|
| Lewis T. Knotnik
|
| Vol #:
|
| 4
|
| |
|
|
| EMC
32
|
| National Assn of Chain Drug Stores
|
| Vol #:
|
| 4
|
| |
|
|
| EMC
33
|
| National Council on Patient Information and Education (NCPIE)
|
| Vol #:
|
| 4
|
| |
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| EC 1
|
| Rothermel, Wayne
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| Korsmo, Jill
|
| Vol #:
|
| 1
|
| |
|
|
| EC 4
|
| Barnes, William
|
| Vol #:
|
| 1
|
| |
|
|
| EC 5
|
| Haskett, Debbie
|
| Vol #:
|
| 1
|
| |
|
|
| EC 6
|
| Hulsey, Carrie
|
| Vol #:
|
| 1
|
| |
|
|
| EC 7
|
| Smith, Emily
|
| Vol #:
|
| 1
|
| |
|
|
| EC 8
|
| Hugo, Gigi
|
| Vol #:
|
| 1
|
| |
|
|
| EC 9
|
| Palko, Joseph
|
| Vol #:
|
| 1
|
| |
|
|
| EC 10
|
| Johnson, Conny
|
| Vol #:
|
| 1
|
| |
|
|
| EC 12
|
| Schnell, Tracy
|
| Vol #:
|
| 1
|
| |
|
|
| EC 13
|
| Hall, Kathleen
|
| Vol #:
|
| 1
|
| |
|
|
| EC 15
|
| Bartlett, Paul
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EC 17
|
| DiPrete, Ken
|
| Vol #:
|
| 1
|
| |
|
|
| EC 18
|
| Bard, Becky
|
| Vol #:
|
| 1
|
| |
|
|
| EC 19
|
| Cockrum, Sky
|
| Vol #:
|
| 1
|
| |
|
|
| EC 20
|
| Conger, Jaimie
|
| Vol #:
|
| 1
|
| |
|
|
| EC 21
|
| Wiley, John
|
| Vol #:
|
| 1
|
| |
|
|
| EC 22
|
| Reilly, Frank
|
| Vol #:
|
| 1
|
| |
|
|
| EC 23
|
| Ward, Cheryl
|
| Vol #:
|
| 1
|
| |
|
|
| EC 24
|
| cattellion, carine
|
| Vol #:
|
| 1
|
| |
|
|
| EC 25
|
| Cates, Jodiann
|
| Vol #:
|
| 1
|
| |
|
|
| EC 26
|
| Jung, Adam
|
| Vol #:
|
| 1
|
| |
|
|
| EC 27
|
| Jung, Holly
|
| Vol #:
|
| 1
|
| |
|
|
| EC 28
|
| Peters, Stacey
|
| Vol #:
|
| 1
|
| |
|
|
| EC 29
|
| Stanton, Sue
|
| Vol #:
|
| 1
|
| |
|
|
| EC 30
|
| Ervin, Jean
|
| Vol #:
|
| 1
|
| |
|
|
| EC 31
|
| Bechtholt, Susan
|
| Vol #:
|
| 1
|
| |
|
|
| EC 32
|
| Cochran, Pamela
|
| Vol #:
|
| 1
|
| |
|
|
| EC 33
|
| Martin, Beverly
|
| Vol #:
|
| 1
|
| |
|
|
| EC 34
|
| slovak, suzanne
|
| Vol #:
|
| 1
|
| |
|
|
| EC 35
|
| James, Peter
|
| Vol #:
|
| 1
|
| |
|
|
| EC 36
|
| Lind, Charlotte
|
| Vol #:
|
| 1
|
| |
|
|
| EC 37
|
| RASH, Linda
|
| Vol #:
|
| 1
|
| |
|
|
| EC 38
|
| OWENS, DONNA
|
| Vol #:
|
| 1
|
| |
|
|
| EC 39
|
| Wills, Tracy
|
| Vol #:
|
| 1
|
| |
|
|
| EC 40
|
| Charland, Roberta
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 2
|
| Prairie Exotics, Ltd
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 3
|
| No signature
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 4
|
| Steven V. Matthews
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 5
|
| Kathy Gee
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 6
|
| Bonnie Winters
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 7
|
| Janet Bradley
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 8
|
| Paul Bartlett
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 9
|
| Lynne Alberts
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 10
|
| Lynne Alberts
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 11
|
| Frann Harrison
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0422
|
| Annual Stakeholder Meeting on the Implementation of MDUFMA Provisions
|
| |
|
|
| EC 2
|
| Touhey, Paul
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EC 3
|
| Wildman, Patrick
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0021
|
| Withdrawal of Wydase, Hyaluronidase Injection
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0479
|
| Allow importation of Canadian versions of drugs that are approved to the United States
|
| |
|
|
| EMC 1
|
| Bill Scarbro
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 2
|
| Lou Tuccillo
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 3
|
| James Townsend
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 4
|
| Ellen Latoria
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0520
|
| Laser Light Show
|
| |
|
|
| CP 1
|
| NUMBER NOT USED
|
| Vol #:
|
| 1
|
| |
|
|
| 2003V-0521
|
| Laser Light Show
|
| |
|
|
| ACK 1
|
| HFA-305 to Heritage Planetarium
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| Heritage Planetarium
|
| Vol #:
|
| 1
|
|
|
