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Dockets Entered On June 24. 2003
TABLE OF
CONTENTS (Linked) |
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Docket # |
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Title
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2000N-1484
|
|
Safety Reporting Requirements
Human Drug/Biological Products |
|
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2000N-1571
|
|
Enrofloxacin for Poultry: Opportunity
for Hearing |
|
|
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2002N-0204
|
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Bar Code Label Requirements
for human drug products |
|
|
|
2002N-0500
|
|
Classification of Silicone
Sheeting |
|
|
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2002N-0528
|
|
Risk Management Workshop, April
9-11, 2003 [PDUFA III] |
|
|
|
2003D-0044
|
|
Reporting Results for Studies
Evaluating Diagnostic Tests |
|
|
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2003D-0118
|
|
Decorative Contact Lens (Import
alert #86-10) |
|
|
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2003D-0137
|
|
Surgical Masks - Premarket
Notification [510(k)] Submissions; Draft Guidance for Industry and
FDA; Availability |
|
|
|
2003D-0186
|
|
Guidance for Industry: Use
of Material From Deer and Elk In Animal Feed |
|
|
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2003N-0069
|
|
FDA Task Force on Consumer
Health Info for Better Nutrition |
|
|
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2003N-0158
|
|
Specification for Annotated
Electrocardiographic Waveform |
|
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2003N-0169
|
|
Dental Amalgam; Request for
Information |
|
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2003P-0289
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outlaw and prohibit the use
of hydrogenated and partially hydrogenated fats in all prepared,manufactured
and processed food products intended for human consumption |
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2003P-0291
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Enforce the law and prevent
unlaw sale of contact lens |
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2003P-0292
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to permit the filing of an
ANDA for a Ceftazidime for Injection,UPS,phamacy bulk package in
a 100 gram dosage strength packaged in plastic bags that are contained within foil outer wraps |
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CONTENTS |
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1999F-4372 |
|
National Fisheries Institute
and the Louisiana Dep of Agricu |
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EMC 434 |
|
Simon Ireland |
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Vol #: |
|
8 |
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EMC 435 |
|
Phyllis Aniya Sladek
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Vol #: |
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8 |
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1999F-5321 |
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Food Safety & Inspection
service safe use of ionizing radiai |
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EMC 337 |
|
Simon Ireland |
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Vol #: |
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8 |
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EMC 338 |
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Phyllis Aniya Sladek
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Vol #: |
|
8 |
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1999F-5322 |
|
Ionizing Radiation for the
Treatment of Food |
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EMC 336 |
|
Simon Ireland |
|
Vol #: |
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6 |
|
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EMC 337 |
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Phyllis Aniya Sladek
|
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Vol #: |
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6 |
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1999F-5522 |
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Ionizing radiation /control
of Food-borne pathogens safe use |
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EMC 339 |
|
Simon Ireland |
|
Vol #: |
|
6 |
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EMC 340 |
|
Phyllis Aniya Sladek
|
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Vol #: |
|
6 |
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2000N-1484 |
|
Safety
Reporting Requirements Human Drug/Biological Products |
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EMC 6 |
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Washington Uiversity Medical Center
|
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Vol #: |
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3 |
|
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2000N-1571 |
|
Enrofloxacin
for Poultry: Opportunity for Hearing |
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MO 50 |
|
Bayer Corporation |
|
Vol #: |
|
378 |
|
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RMO 26 |
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Center for Veterinary Medicine
|
|
Vol #: |
|
378 |
|
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2000P-1211 |
|
Establish Mandatory Pre-Market
Safety Testing for GE Foods |
|
|
|
C 12712 |
|
Cassia Batson |
|
Vol #: |
|
788 |
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EMC 5608 |
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Claudette Griffith |
|
Vol #: |
|
788 |
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EMC 5609 |
|
Jennifer Loch |
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Vol #: |
|
788 |
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EMC 5610 |
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Gretchyn Bailey |
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Vol #: |
|
788 |
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EMC 5611 |
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Laura Andrews |
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Vol #: |
|
788 |
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EMC 5612 |
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Lindsay Mackenzie |
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Vol #: |
|
788 |
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EMC 5613 |
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Eric Paul Jacobsen |
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Vol #: |
|
788 |
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EMC 5615 |
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Suzanne Ferreira |
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Vol #: |
|
788 |
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EMC 5617 |
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Andrew McGrath |
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Vol #: |
|
788 |
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EMC 5618 |
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Lisamarie McGrath |
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Vol #: |
|
788 |
|
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EMC 5619 |
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PJ Perkins |
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Vol #: |
|
788 |
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EMC 5620 |
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Dorothy B Bucklin |
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Vol #: |
|
788 |
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EMC 5621 |
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Nikki Sexton |
|
Vol #: |
|
788 |
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EMC 5622 |
|
Nicole Cherok |
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Vol #: |
|
788 |
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EMC 5623 |
|
John Crockett |
|
Vol #: |
|
788 |
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EMC 5624 |
|
Molly Steele |
|
Vol #: |
|
788 |
|
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EMC 5625 |
|
Sarah Reichert |
|
Vol #: |
|
788 |
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EMC 5626 |
|
Sarah Reichert |
|
Vol #: |
|
788 |
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EMC 5627 |
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Nona Sturdevatn |
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Vol #: |
|
788 |
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EMC 5628 |
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Gina Zondorak |
|
Vol #: |
|
788 |
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EMC 5629 |
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Nicole Gershon |
|
Vol #: |
|
788 |
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EMC 5630 |
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Harriet Sharp |
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Vol #: |
|
788 |
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EMC 5631 |
|
Jason Mayfield |
|
Vol #: |
|
788 |
|
|
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EMC 5632 |
|
Simon Ireland |
|
Vol #: |
|
788 |
|
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EMC 5634 |
|
Brendon Drew |
|
Vol #: |
|
788 |
|
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EMC 5635 |
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Diane Thompson |
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Vol #: |
|
788 |
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EMC 5636 |
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Jennifer Dedrick |
|
Vol #: |
|
788 |
|
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EMC 5637 |
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Phyllis Aniya Sladeck
|
|
Vol #: |
|
788 |
|
|
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EMC 5639 |
|
Michael Pellecchia |
|
Vol #: |
|
788 |
|
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EMC 5640 |
|
S J Todd |
|
Vol #: |
|
788 |
|
|
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EMC 5641 |
|
Colin NG |
|
Vol #: |
|
788 |
|
|
|
|
|
EMC 5642 |
|
Constance Sheldon |
|
Vol #: |
|
788 |
|
|
|
|
|
2001F-0047 |
|
Foodborne pathogens in raw-frozen-cooked-partially
cooked |
|
|
|
EMC 441 |
|
Simon Ireland |
|
Vol #: |
|
8 |
|
|
|
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|
EMC 442 |
|
Phyllis Aniya Sladek
|
|
Vol #: |
|
8 |
|
|
|
|
|
2001P-0075 |
|
Switch Status of Emergency
Contraceptives from Rx to OTC |
|
|
|
EMC 446 |
|
Matt Siegel |
|
Vol #: |
|
39 |
|
|
|
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EMC 447 |
|
No signature |
|
Vol #: |
|
39 |
|
|
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EMC 448 |
|
Margaret O'Neal |
|
Vol #: |
|
39 |
|
|
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EMC 449 |
|
Gina Gambidilla et al.
|
|
Vol #: |
|
39 |
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EMC 450 |
|
Laurie Rosenzweig |
|
Vol #: |
|
39 |
|
|
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2001P-0345 |
|
Listing the color additive
yellow #5 for use in food/Drug |
|
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EMC 1177 |
|
Chris Conforti |
|
Vol #: |
|
5 |
|
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EMC 1178 |
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Donnie P. Ducharme |
|
Vol #: |
|
5 |
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EMC 1179 |
|
Ken Kucera |
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Vol #: |
|
5 |
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EMC 1180 |
|
Evan Jaundzems |
|
Vol #: |
|
5 |
|
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|
2002D-0325 |
|
Polyvinychloride using Plasticier
di-(2-ethyhexyl)phthalate |
|
|
|
EMC 114 |
|
Benjamin Rivkind |
|
Vol #: |
|
3 |
|
|
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EMC 115 |
|
Christine Maloney |
|
Vol #: |
|
3 |
|
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|
EMC 116 |
|
Claire Wallace |
|
Vol #: |
|
3 |
|
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EMC 117 |
|
Mary Teurman |
|
Vol #: |
|
3 |
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EMC 118 |
|
Charis A. McGuire |
|
Vol #: |
|
3 |
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EMC 119 |
|
Karen Lionetti |
|
Vol #: |
|
3 |
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EMC 120 |
|
Linda Daniel |
|
Vol #: |
|
3 |
|
|
|
|
|
2002N-0204 |
|
Bar
Code Label Requirements for human drug products |
|
|
|
EMC 177 |
|
Koss on Care,LLC |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 178 |
|
National Quality Forum (NQF)
|
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 179 |
|
Merck & Co., Inc. |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 180 |
|
American Assn of Blood Banks
(AABB) |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 181 |
|
National Alliance for Health
Information Technology (the "Alliance") |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 182 |
|
Industry Forum Subcommittee
of VISI |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 183 |
|
American Medical Assn (AMA)
|
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 184 |
|
Interagency Regulatory Analysis
Committee |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 185 |
|
Academy of Managed Care Pharmacy
(AMCP) |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 186 |
|
Health Industry Business Communications
Council (HIBCC) |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 187 |
|
Tri-TAC |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 188 |
|
Uniform Code Council
|
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 189 |
|
National Assn of Chain Drug
Stores |
|
Vol #: |
|
16 |
|
|
|
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|
EMC 190 |
|
America's Blood Centers
|
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 191 |
|
Printronix, Inc. |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 192 |
|
AIM, Inc. |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 193 |
|
RDG & BarCodeAmerica.com
|
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 194 |
|
American Academy of Orthopaedic
Surgeons (AAOS/Academy) |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 195 |
|
Healthcare Distribution Management
Assn |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 196 |
|
Healthcare Information and
Managemet Systems Society (HIMSS) |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 197 |
|
GlaxoSmithKline (GSK)
|
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 198 |
|
McKesson Corporation
|
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 199 |
|
DocuSys, Inc. |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 200 |
|
American Assn of Critical Care
Hurses |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 201 |
|
Bridge Medical |
|
Vol #: |
|
16 |
|
|
|
|
|
EMC 202 |
|
Bridge Medical |
|
Vol #: |
|
16 |
|
|
|
|
|
2002N-0277 |
|
Bioterrorism; Establishment
& Maintenance of Records |
|
|
|
EMC 26 |
|
Kraft Foods |
|
Vol #: |
|
8 |
|
|
|
|
|
EMC 27 |
|
Irish Exporters Assn |
|
Vol #: |
|
8 |
|
|
|
|
|
2002N-0278 |
|
Bioterrorism; Prior Notice
of Imported Food Shipments |
|
|
|
EMC 111 |
|
Number Not Used |
|
Vol #: |
|
14 |
|
|
|
|
|
EMC 112 |
|
Irish Exporters Assn
|
|
Vol #: |
|
14 |
|
|
|
|
|
2002N-0417 |
|
Applications for FDA Approval
to Market a New Drug |
|
|
|
|
|
|
|
EMC 10 |
|
Greg Miller |
|
Vol #: |
|
4 |
|
|
|
|
|
2002N-0500
|
|
Classification
of Silicone Sheeting |
|
|
|
EMC 1 |
|
National Center for Policy
research for Women and Families |
|
Vol #: |
|
1 |
|
|
|
|
|
2002N-0528
|
|
Risk
Management Workshop, April 9-11, 2003 [PDUFA III] |
|
|
|
EMC 36 |
|
Applied Clinical Intelligence,
LLC |
|
Vol #: |
|
8 |
|
|
|
|
|
EMC 37 |
|
Bristol-Myers Squibb
|
|
Vol #: |
|
8 |
|
|
|
|
|
EMC 38 |
|
Genentech, Inc. |
|
Vol #: |
|
8 |
|
|
|
|
|
2002P-0317 |
|
Recall Aspartame as a Neurotoxic
Drug |
|
|
|
EMC 250 |
|
Betty Martini |
|
Vol #: |
|
5 |
|
|
|
|
|
EMC 251 |
|
Betty Martini |
|
Vol #: |
|
5 |
|
|
|
|
|
EMC 252 |
|
Betty Martini |
|
Vol #: |
|
5 |
|
|
|
|
|
EMC 253 |
|
Peggy Mouton |
|
Vol #: |
|
5 |
|
|
|
|
|
EMC 254 |
|
Sherry Kaufman |
|
Vol #: |
|
5 |
|
|
|
|
|
2003D-0044
|
|
Reporting
Results for Studies Evaluating Diagnostic Tests |
|
|
|
EMC 1 |
|
Dade Behring, Inc. |
|
Vol #: |
|
1 |
|
|
|
|
|
2003D-0118
|
|
Decorative Contact Lens (Import
alert #86-10) |
|
|
|
EMC 2 |
|
Contact Lens Institute (CLI)
|
|
Vol #: |
|
1 |
|
|
|
|
|
2003D-0137
|
|
Surgical Masks - Premarket
Notification [510(k)] Submissions; Draft Guidance for Industry and
FDA; Availability |
|
|
|
EMC 1 |
|
3M Center |
|
Vol #: |
|
1 |
|
|
|
|
|
EMC 2 |
|
Kimberly-Clark Health Care
|
|
Vol #: |
|
1 |
|
|
|
|
|
2003D-0186
|
|
Guidance for Industry: Use
of Material From Deer and Elk In Animal Feed |
|
|
|
EMC 3 |
|
National Assn of Fish and Wildlife
Agencies (IAFWA) |
|
Vol #: |
|
1 |
|
|
|
|
|
EMC 4 |
|
Nebraska Game and Parks Commission
|
|
Vol #: |
|
1 |
|
|
|
|
|
EMC 5 |
|
National By-Products, LLC (NBP)
|
|
Vol #: |
|
1 |
|
|
|
|
|
EMC 6 |
|
Darling International, Inc.
|
|
Vol #: |
|
1 |
|
|
|
|
|
2003M-0240 |
|
P990069 - EPMed Systems, Inc.,
ALERTB. System (ALERTB. Catheter, ALERTB. Interface Cable, and ALERTB.
Companion with Software Version 1.08 |
|
|
|
AAV 1 |
|
EPMed Systems, Inc.
|
|
Vol #: |
|
1 |
|
|
|
|
|
2003M-0241 |
|
P020028 - Series 50 XMO (Model
M1350C) Fetal/Maternal Monitor System with Integrated Fetal Oxygen
Saturation Monitoring |
|
|
|
AAV 1 |
|
Philips Medical Systems, Inc.
|
|
Vol #: |
|
1 |
|
|
|
|
|
2003M-0262 |
|
PMA Immulite HBsAG Confirmatory
Kit, P010050 |
|
|
|
AAV 1 |
|
Diagnostic Products Corporation
|
|
Vol #: |
|
1 |
|
|
|
|
|
2003M-0271 |
|
P010051 - IMMULITEB. Anti-HBc
and IMMULITEB. 2000 Anti-HBc, Approved 6/24/02 |
|
|
|
AAV 1 |
|
Diagnostic Products Corporation
|
|
Vol #: |
|
1 |
|
|
|
|
|
2003M-0272 |
|
P010053 - IMMULITEB. Anti-HBc
IgM and IMMULITEB. 2000 Anti-HBc IgM, Approved 7/26/02 |
|
|
|
AAV 1 |
|
Diagnostic Products Corporation
|
|
Vol #: |
|
1 |
|
|
|
|
|
2003M-0287 |
|
P010052 - IMMULITEB. Anti-HBs
and IMMULITEB. 2000 Anti-HBs, Approved 7/22/02 |
|
|
|
AAV 1 |
|
Diagnostic Products Corporation
|
|
Vol #: |
|
1 |
|
|
|
|
|
2003N-0056 |
|
Patient Examination & Surgeons'
Gloves; Test Procedures |
|
|
|
EMC 2 |
|
Victoria Steelman, PhD, RN
|
|
Vol #: |
|
1 |
|
|
|
|
|
EMC 3 |
|
Peter Yew Nieng Choon
|
|
Vol #: |
|
1 |
|
|
|
|
|
2003N-0069 |
|
FDA
Task Force on Consumer Health Info for Better Nutrition |
|
|
|
EMC 9 |
|
American Dietetic Assn
|
|
Vol #: |
|
1 |
|
|
|
|
|
2003N-0158
|
|
Specification for Annotated
Electrocardiographic Waveform |
|
|
|
EMC 5 |
|
National Electrical Manufacturers
Assn (NEMA) |
|
Vol #: |
|
1 |
|
|
|
|
|
2003N-0169 |
|
Dental
Amalgam; Request for Information |
|
|
|
EMC 129 |
|
Mercury Exposure |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 130 |
|
Wanda Brown |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 131 |
|
American Student Dental Assn
|
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 132 |
|
Wisconsin Dental Assn
|
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 133 |
|
Ronald L. King, DDS
|
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 134 |
|
No signature |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 135 |
|
Freya Koss |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 136 |
|
S. Korel, DMD |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 137 |
|
Ronald L. King, DDS
|
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 138 |
|
Murlene Brake |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 139 |
|
Freya Koss |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 140 |
|
Dr. Michael Lewis |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 141 |
|
Bernard Windham |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 142 |
|
Bernard Windham |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 143 |
|
Bernard Windham |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 144 |
|
Bernard Windham |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 145 |
|
Maryanne Rygg |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 146 |
|
Maryanne Rygg |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 147 |
|
Maryanne Rygg |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 148 |
|
Birgit Calhoun |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 149 |
|
Birgit Calhoun |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 150 |
|
Bernard Windham |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 151 |
|
Debbie Bevel |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 152 |
|
Debbie Bevel |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 153 |
|
Debbie Bevel |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 154 |
|
Stuart Scheckner,DMD
|
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 155 |
|
Dr. Peter Kraub |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 156 |
|
Vanja Karlsson Sweden
|
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 157 |
|
No signature |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 158 |
|
Bernard Windham |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 159 |
|
Bernard Windham |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 160 |
|
Bernard Windham |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 161 |
|
Bernard Windham |
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 162 |
|
Consumers for Dental Choice
|
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 163 |
|
Consumers for Dental Choice
|
|
Vol #: |
|
3 |
|
|
|
|
|
EMC 164 |
|
Consumers for Dental Choice
|
|
Vol #: |
|
3 |
|
|
|
|
|
2003P-0289 |
|
outlaw
and prohibit the use of hydrogenated and partially hydrogenated
fats in all prepared,manufactured and processed food products intended
for human consumption |
|
|
|
ACK 1 |
|
HFA-305 to Diana E. Kelly
|
|
Vol #: |
|
1 |
|
|
|
|
|
CP 1 |
|
Diana E. Kelly |
|
Vol #: |
|
1 |
|
|
|
|
|
2003P-0291 |
|
Enforce
the law and prevent unlaw sale of contact lens |
|
|
|
ACK 1 |
|
HFA- 305 to The National Contact
Lens Enforement Petition |
|
Vol #: |
|
1 |
|
|
|
|
|
CP 1 |
|
Tim Milburn O.D. |
|
Vol #: |
|
1 |
Attachments |
|
|
|
|
2003P-0292 |
|
to
permit the filing of an ANDA for a Ceftazidime for Injection,UPS,phamacy
bulk package in a 100 gram dosage strength packaged in plastic bags
that are contained within foil outer wraps |
|
|
|
ACK 1 |
|
HFA-305 to Samson Medical Technologies,L.L.C.
|
|
Vol #: |
|
1 |
|
|
|
|
|
CP 1 |
|
Samson Medical Technologies,
L.L.C. |
|
Vol #: |
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
