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| Dockets
Entered On November 21, 2003
Table of Contents
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| Docket #
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| Title
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| 1978N-0064
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| OTC Antiperspirant
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| 1996D-0009
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| Impurities in new drug products guideline
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| 1998E-0849
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| Patent Extension 4,490,351 VITREON
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| |
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| 1998E-1217
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| Patent Extension, Topomax, 4,513,006
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| |
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| |
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| 1999E-5112
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| Patent Extension Novoseven, #4,784,950
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| |
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| 1999N-1168
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| Public Health Impact of Foodborne Listeria Monocytogenes
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| |
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| |
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| |
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| 2000E-1238
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| Patent Extension Temodar (temozolomide), #5,260,291
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| |
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| 2000E-1239
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| Patent Extension Rapamune (sirolimus), #5,100,899
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| 2000E-1248
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| Patent Extension Tikosyn (dofetilide) #4,959,366
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| |
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| 2000E-1249
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| Patent Extension Avandia #5,002,953
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| |
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| 2000P-1275
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| Health Claim: Vegetable oil sterol esters & coronary heart d
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| 2000P-1276
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| Health Claim: Plant stanol esters and heart disease
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| 2001N-0067
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| Reclassification of Dental Mercury
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| |
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| |
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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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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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| |
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| 2002P-0163
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| Expedite Over-the-Counter Approval for Desloratidine
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| |
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| |
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| 2003D-0204
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| Guidance for Industry: IRB Review of Stand-Alone HIPAA Authorizations; Availability
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| |
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| 2003D-0290
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| Compounding of Drugs for Use in Animals Compliance Policy Guide
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| |
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| 2003D-0349
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| Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
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| |
|
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| 2003D-0382
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| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
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| |
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| 2003D-0493
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| Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
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| |
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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
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| |
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| 2003N-0169
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| Dental Amalgam; Request for Information
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| |
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| 2003N-0338
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| Obesity
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| |
|
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| 2003N-0346
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| Food Labeling: Ingredient Labeling of Dietary Supplements That Contain Botanicals
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| |
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| |
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2003N-0472
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| Statement of Work for the Evaluation of First Cycle Review Performance; Availability
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| 2003N-0482
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Mammography Facilities, Standards, and Lay Summaries for Patients
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| |
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| 2003P-0162
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| Import Canadian food products that do not meet labeling regs
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| 2003P-0274
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| In re Tier 1 initial Approval Program
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| | | | | | | | |
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| |
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| 2003P-0479
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| Allow importation of Canadian versions of drugs that are approved to the United States
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| |
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| 2003P-0534
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| Glyburide and metformin hydrochloride Oral Solution 1.25 mg/250 mg per 5 mL; 2.5 mg/500 mg per 10
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| 1978N-0064
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| OTC Antiperspirant
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| |
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| C
49
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| HFD-560 to Sidley Austin Brown & Wood, LLP
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| Vol #:
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| 51
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| C
50
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| HFD-560 to Hill Top Research, Inc.
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| Vol #:
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| 51
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| C
51
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| HFD-560 to Hill Top Research, Inc.
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| Vol #:
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| 51
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| C
52
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| HFD-560 to Hill Top Research, Inc.
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| Vol #:
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| 51
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| 1996D-0009
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| Impurities in new drug products guideline
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| |
|
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| GDL
1
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| GUIDANCE
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| Vol #:
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| 1
|
| |
|
|
| NAD
4
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| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 1998E-0849
|
| Patent Extension 4,490,351 VITREON
|
| |
|
|
| LET
5
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| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 1998E-1217
|
| Patent Extension, Topomax, 4,513,006
|
| |
|
|
| LET
3
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| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| |
|
|
| C 7275
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| Eugenia A. Frashier
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| Vol #:
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| 303
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| |
|
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| C 7276
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| Georgia Meyers
|
| Vol #:
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| 303
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| |
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| C 7277
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| Jane Schwartz
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| Vol #:
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| 303
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| |
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| C 7278
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| Rev. Tammy Toepke-Floyd
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| Vol #:
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| 303
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| C 7279
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| Charles Sehorn
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| Vol #:
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| 303
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| C 7280
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| Carolyn Bearden
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| Vol #:
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| 303
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| C 7281
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| Paula Berry
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| Vol #:
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| 303
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| |
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| C 7282
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| Patricia Miller
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| Vol #:
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| 303
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| |
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| C 7283
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| Katherine
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| Vol #:
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| 303
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| |
|
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| C 7284
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| Karen Turnbull
|
| Vol #:
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| 303
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| |
|
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| C 7285
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| Joyce a & Morgan Margraf
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| Vol #:
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| 303
|
| |
|
|
| 1999E-5112
|
| Patent Extension Novoseven, #4,784,950
|
| |
|
|
| LET
3
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 1999N-1168
|
| Public Health Impact of Foodborne Listeria Monocytogenes
|
| |
|
|
| NM
4
|
| FDA
|
| Vol #:
|
| 21
|
|
| | | | | | | | |
| |
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
| |
|
|
| EMC 4078
|
| James Stout
|
| Vol #:
|
| 514
|
| |
|
|
| EMC 4079
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| Mike Perez
|
| Vol #:
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| 514
|
| |
|
|
| EMC 4080
|
| Jill Albanese
|
| Vol #:
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| 514
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| |
|
|
| EMC 4081
|
| Lorissa Byely
|
| Vol #:
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| 514
|
| |
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
| |
|
|
| EMC 689
|
| Morton Genser
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 690
|
| Joyce Tapiero
|
| Vol #:
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| 32
|
| |
|
|
| EMC 691
|
| Joan S. Frank,MS,RD
|
| Vol #:
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| 32
|
| |
|
|
| EMC 692
|
| PT Trammel
|
| Vol #:
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| 32
|
| |
|
|
| EMC 693
|
| Paul RW Anthony
|
| Vol #:
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| 32
|
| |
|
|
| EMC 694
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| John Riddell
|
| Vol #:
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| 32
|
| |
|
|
| EMC 695
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| Kristen Fitzgerald
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| Vol #:
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| 32
|
| |
|
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| EMC 696
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| Kelly Minehan
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| Vol #:
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| 32
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| |
|
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| EMC 697
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| Kris Patterson
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| Vol #:
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| 32
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| |
|
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| EMC 698
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| Alissa Dewaele
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| Vol #:
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| 32
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| |
|
|
| EMC 699
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| Allison Chait
|
| Vol #:
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| 32
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| |
|
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| EMC 700
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| Sharon Foster
|
| Vol #:
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| 32
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| |
|
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| EMC 701
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| Alicia Bakowski
|
| Vol #:
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| 32
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| |
|
|
| EMC 702
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| Matthew Spencer
|
| Vol #:
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| 32
|
| |
|
|
| EMC 703
|
| Lauren Anderson
|
| Vol #:
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| 32
|
| |
|
|
| 2000E-1238
|
| Patent Extension Temodar (temozolomide), #5,260,291
|
| |
|
|
| LET
4
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2000E-1239
|
| Patent Extension Rapamune (sirolimus), #5,100,899
|
| |
|
|
| LET
3
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2000E-1248
|
| Patent Extension Tikosyn (dofetilide) #4,959,366
|
| |
|
|
| LET
3
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2000E-1249
|
| Patent Extension Avandia #5,002,953
|
| |
|
|
| LET
3
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2000P-1275
|
| Health Claim: Vegetable oil sterol esters & coronary heart d
|
| |
|
|
| SUP
2
Attachment
|
| Raisio Benecol, Ltd
|
| Vol #:
|
| 22
|
| |
|
|
| 2000P-1276
|
| Health Claim: Plant stanol esters and heart disease
|
|
| | | | | | | | |
| |
|
|
| SUP
2
Attachment
|
| Raisio Benecol, Ltd
|
| Vol #:
|
| 22
|
| |
|
|
| 2001N-0067
|
| Reclassification of Dental Mercury
|
| |
|
|
| EMC 653
|
| Jacek Nowicki
|
| Vol #:
|
| 17
|
| |
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
| |
|
|
| EMC 3145
|
| Mike Perez
|
| Vol #:
|
| 252
|
| |
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
| |
|
|
| EMC 1207
|
| Vida Yarn
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 1208
|
| Glenda Patterson
|
| Vol #:
|
| 5
|
| |
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
| |
|
|
| EMC
104
|
| Fattorie Girau, snc
|
| Vol #:
|
| 15
|
| |
|
|
| EMC
105
|
| M.G. Maher & Co., Inc.
|
| Vol #:
|
| 15
|
| |
|
|
| NCR
2
|
| FDA
|
| Vol #:
|
| 15
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| EMC
125
|
| W.J. Byrnes & Co.
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 126
|
| Tania Delgado
|
| Vol #:
|
| 17
|
| |
|
|
| NCR
1
|
| FDA
|
| Vol #:
|
| 17
|
| |
|
|
| 2002P-0163
|
| Expedite Over-the-Counter Approval for Desloratidine
|
| |
|
|
| EMC
6
|
| National Organization for African-Americans
in Housing (NOAAH)
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC 286
|
| Betty Martini
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 287
|
| Betty Martini
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 288
|
| Betty Martini
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 289
|
| Betty Martini
|
| Vol #:
|
| 5
|
| |
|
|
| 2003D-0204
|
| Guidance for Industry: IRB Review of Stand-Alone HIPAA Authorizations; Availability
|
| |
|
|
| GDL
1
|
| GUIDANCE
|
| Vol #:
|
| 1
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0290
|
| Compounding of Drugs for Use in Animals Compliance Policy Guide
|
| |
|
|
| EMC 1
|
| Olivia Bravo
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 2
|
| Rod Gilbert
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0349
|
| Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
|
| |
|
|
| EMC
2
|
| United States Pharmacopeia
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| EMC
3
|
| Xcyte Therapies, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0382
|
| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
|
| |
|
|
| EMC
34
|
| DSM Pharmaceuticals, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 35
|
| Bill Whyte
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
36
|
| Baxter Healthcare Corporation
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
37
|
| Air Techniques International
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
38
|
| Quality Systems Consulting, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
39
|
| Delaware Valley Chapter of PDA
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
40
Attachment
|
| PhRMA
|
| Vol #:
|
| 3
|
| |
|
|
| 2003D-0493
|
| Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
|
| |
|
|
| EMC
1
|
| FAME Systems
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
2
|
| FAME Systems
|
| Vol #:
|
| 1
|
| |
|
|
| GDL
1
|
| GUIDANCE
|
| Vol #:
|
| 1
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC 104
|
| Christyann Blair
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 105
|
| Bill H. Kelly, Sr.
|
| Vol #:
|
| 3
|
| |
|
|
| 2003N-0169
|
| Dental Amalgam; Request for Information
|
| |
|
|
| EMC
222
|
| American Dental Assn (ADA)
|
| Vol #:
|
| 6
|
| |
|
|
| 2003N-0338
|
| Obesity
|
| |
|
|
| EMC 17
|
| Lora
|
| Vol #:
|
| 6
|
| |
|
|
| EMC
18
|
| National Restaurant Assn
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 19
|
| Pat Ballard
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 20
|
| Robert P. Heaney, MD
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 21
|
| Sandy Szwarc,RN,BSN,CCP
|
| Vol #:
|
| 6
|
| |
|
|
| EMC
22
|
| International College for the Advancement of Nutrition (ICAN)
|
| Vol #:
|
| 6
|
| |
|
|
| EMC
23
|
| International College for the Advancement of Nutrition (ICAN)
|
| Vol #:
|
| 6
|
| |
|
|
| 2003N-0346
|
| Food Labeling: Ingredient Labeling of Dietary Supplements That Contain Botanicals
|
| |
|
|
| EMC
1
|
| Jarrow Formulas, Inc. (JFI)
|
| Vol #:
|
| 4
|
| |
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
| |
|
|
| EMC
34
Attachment
|
| Hyperspace Communications, Inc.
|
| Vol #:
|
| 4
|
| |
|
|
| EMC
35
|
| Authentimed, Inc.
|
| Vol #:
|
| 4
|
|
| | | | | | | | |
| |
|
|
| EMC
36
|
| NNC Group
|
| Vol #:
|
| 4
|
| |
|
|
| EMC
37
|
| PA Consulting Group
|
| Vol #:
|
| 4
|
| |
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| EMC
12
|
| Prairie Exotics, Ltd
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0472
|
| Statement of Work for the Evaluation of First Cycle Review Performance; Availability
|
| |
|
|
| EMC
1
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0482
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Mammography Facilities, Standards, and Lay Summaries for Patients
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0162
|
| Import Canadian food products that do not meet labeling regs
|
| |
|
|
| ACK 2
|
| HFA-305 to JM Investment Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
2
|
| JM Investment Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0274
|
| In re Tier 1 initial Approval Program
|
| |
|
|
| EMC 13
|
| Cindy Clark
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
14
|
| Ropes & Gray, LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
| |
|
|
| EMC 3
|
| No signature
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 4
|
| Herbert N. Jordan
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 5
|
| Julie A. Sidak, MS, CCC/A
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0479
|
| Allow importation of Canadian versions of drugs that are approved to the United States
|
| |
|
|
| EMC 5
|
| No signature
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 6
|
| Thomas Lembessis
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 7
|
| D. Russell Mercer
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 8
|
| Alan Campbell
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 9
|
| No signature
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 10
|
| No signature
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 11
|
| William Wright
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 12
|
| Mike & Leila Merims
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 13
|
| Fred Yontz
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 14
|
| Carl Lobaugh
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 15
|
| D. Kenyon
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 16
|
| Lisa Chappell
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 17
|
| Mike Ross
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| EMC 18
|
| Jamie Wild
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 19
|
| No signature
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0534
|
| Glyburide and metformin hydrochloride Oral Solution 1.25 mg/250 mg per 5 mL; 2.5 mg/500 mg per 10
|
| |
|
|
| ACK
1
|
| HFA-305 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| ACK 2
|
| number not used
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Attachment
1, 2,
3
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
Page created November 24, 2003 jb
Page udpated December 22, 2003 jb
|
