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| Dockets Entered
On April 9, 2004
Table of Contents
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| Docket #
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| Title
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| 1981N-0033
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| Oral Health Care Drug Products for OTC Human Use
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| |
|
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| 1982P-0141
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| Laser projection system
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| |
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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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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| |
|
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| 1997P-0079
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| Deny Exclusivity to Nicotine Patch Sub Products for OTC Use
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| |
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| 1997P-0329
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| Require Quantitative Labeling of Caffeine Content
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| |
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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| 1998N-0044
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| Effect of dietary supplement on structure/function of body
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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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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| |
|
|
| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| |
|
|
| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| |
|
|
| 2000N-1396
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| Bioengineered Foods Consumed By Humans or Animals
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| |
|
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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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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| |
|
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| |
|
|
| 2002E-0339
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| Benicar, U.S. Patent No. 5,616,599
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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-0277
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| Bioterrorism; Establishment & Maintenance of Records
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| |
|
|
| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| |
|
|
| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| 2003D-0571
|
| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
|
| |
|
|
| 2003E-0036
|
| Patent Extension Application for SPECTRACEF No. 4,839,350
|
| |
|
|
| 2003E-0146
|
| Patent Extension Application for RELPAX, No. 5,545,644
|
| |
|
|
| 2003E-0154
|
| Patent Term Extension of U.S. Patent #4,328,809
|
| |
|
|
| 2003E-0243
|
| Patent Extension for InFuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device, 5,984,967
|
| |
|
|
| 2003E-0244
|
| Patent InFuse Bone Graft/LT-CAGE Lumbar Tapered Fusion Device, 5,782,919
|
| |
|
|
| 2003E-0402
|
| Patent Term Restoration Application for Acrysof, U.S. Patent No. 5,470,932
|
| |
|
|
| 2003E-0410
|
| Patent Term Restoration Application for Zubrin (tepoxalin), U.S. Patent No. 4,826,868
|
| |
|
|
| 2003E-0457
|
| Patent Extension, SOMAVERT, pegisomant for injection, #5,849,535
|
| |
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| 2003P-0029
|
| Remove metered-dose inhalers (MDI) containing moiety albuter
|
| |
|
|
| 2003P-0393
|
| Diazepam Injection USP, 5 mg/mL, 1-mL,(ANDA No. 72-079), by Abbott laboratories, Inc., has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
|
| |
|
|
| 2003P-0477
|
| Expedite the revocation of determination of the application of the AIP
|
| |
|
|
| 2003P-0544
|
| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
|
| |
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
|
| | | | | | | | |
| |
|
|
| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
| |
|
|
| 2004D-0028
|
| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
|
| |
|
|
| 2004D-0035
|
| Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
|
| |
|
|
| 2004D-0041
|
| Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling
|
| |
|
|
| 2004E-0011
|
| Patenet Term Extention of U.S. patent No. 5,198,533 for Cetrotide (cetrorelix acetate)
|
| |
|
|
| 2004E-0019
|
| Patent Extension, FUZEON (enfuvirtide), U.S. Patent No. 6,133,418
|
| |
|
|
| 2004E-0023
|
| Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate )
|
| |
|
|
| 2004E-0039
|
| Patent Extension for CRESTOR (rosuvastatin), U.S. Patent No. RE37,314
|
| |
|
|
| 2004E-0040
|
| Patent Extension for CYDECTIN, U.S. Patent No. 4,916,154
|
| |
|
|
| 2004M-0165
|
| H020008; OP-1 Putty
|
| |
|
|
| 2004N-0049
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
| |
|
|
| 2004P-0171
|
| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
|
| |
|
|
| 2004Q-0083
|
| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
|
| |
|
|
| 1981N-0033
|
| Oral Health Care Drug Products for OTC Human Use
|
|
|
| LET
57
|
| Consumer Healthcare Products Assn (CHPA)
|
| Vol #:
|
| 70
|
| |
|
|
| 1982P-0141
|
| Laser projection system
|
| |
|
|
| VRA
9
|
| HFZ-300 to Fiske Planetarium and Science Center
|
| Vol #:
|
| 1
|
| |
|
|
| 1995N-0304
|
| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
| |
|
|
| EMC
1279
|
| Mission Possible International
|
| Vol #:
|
| 394
|
| |
|
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
| |
|
|
| RPT
18
Attachment
|
| Northfield Laboratories, Inc.
|
| Vol #:
|
| 25
|
| |
|
|
| 1997P-0079
|
| Deny Exclusivity to Nicotine Patch Sub Products for OTC Use
|
| |
|
|
| LET
2
|
| HFD-007 to Olsson,Frank and Weeda, PC
|
| Vol #:
|
| 1
|
| |
|
|
| 1997P-0329
|
| Require Quantitative Labeling of Caffeine Content
|
| |
|
|
| EMC 111
|
| T. Orth
|
| Vol #:
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| 7
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET
13547
|
| EuroPharma, Inc.
|
| Vol #:
|
| 113
|
| |
|
|
| LET
13548
|
| EuroPharma, Inc.
|
| Vol #:
|
| 113
|
| |
|
|
| LET
13549
|
| EuroPharma, Inc.
|
| Vol #:
|
| 113
|
| |
|
|
| LET
13550
|
| EuroPharma, Inc.
|
| Vol #:
|
| 113
|
| |
|
|
| LET
13551
|
| EuroPharma, Inc.
|
| Vol #:
|
| 113
|
|
| | | | | | | | |
| |
|
|
| LET
13552
|
| EuroPharma, Inc.
|
| Vol #:
|
| 113
|
| |
|
|
| LET
13553
|
| EuroPharma, Inc.
|
| Vol #:
|
| 113
|
| |
|
|
| LET
13554
|
| Lyons Health Products
|
| Vol #:
|
| 113
|
| |
|
|
| LET
13555
|
| Awareness Corporation
|
| Vol #:
|
| 113
|
| |
|
|
| LET
13556
|
| Lakota Ventres
|
| Vol #:
|
| 113
|
| |
|
|
| LET
13557
|
| Nikken, Inc.
|
| Vol #:
|
| 113
|
| |
|
|
| LET
13558
|
| Planetary Formulas
|
| Vol #:
|
| 113
|
| |
|
|
| LET
13559
|
| Planetary Formulas
|
| Vol #:
|
| 113
|
| |
|
|
| 1998N-0044
|
| Effect of dietary supplement on structure/function of body
|
| |
|
|
| C 22418
|
| E. Terry
|
| Vol #:
|
| 883
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| C 7402
|
| C and D Thomas
|
| Vol #:
|
| 307
|
| |
|
|
| C 7403
|
| L. Schumann
|
| Vol #:
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| 307
|
| |
|
|
| EMC 4182
|
| B. Flowers
|
| Vol #:
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| 515
|
| |
|
|
| EMC 4183
|
| R. Freedman
|
| Vol #:
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| 515
|
| |
|
|
| EMC 4184
|
| L. Silverman, Esq
|
| Vol #:
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| 515
|
| |
|
|
| EMC 4185
|
| S. Wilson
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4186
|
| V. Gonzalez
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4187
|
| E. Zucker
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4188
|
| F. Kuhn
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4189
|
| M. Herman
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4190
|
| K. Bellairs
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4191
|
| D. Calvao
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4192
|
| D. Calvao
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4193
|
| C. Rosas
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4194
|
| S. Plug
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4195
|
| N. Lak
|
| Vol #:
|
| 304
|
| |
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
| |
|
|
| C 18225
|
| L. Schumann
|
| Vol #:
|
| 516
|
| |
|
|
| EMC 4193
|
| E. Mauceri
|
| Vol #:
|
| 515
|
| |
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
| |
|
|
| EMC 777
|
| Dorian
|
| Vol #:
|
| 33
|
| |
|
|
| 2000D-1598
|
| Voluntary Labeling for Bioengineered Foods
|
| |
|
|
| EMC 12018
|
| Aileen Tamai
|
| Vol #:
|
| 574
|
|
| | | | | | | | |
| |
|
|
| 2000N-1396
|
| Bioengineered Foods Consumed By Humans or Animals
|
| |
|
|
| EMC 11572
|
| A. Tamai
|
| Vol #:
|
| 349
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| C 1339
|
| Mr and Mrs J. Nugent
|
| Vol #:
|
| 209
|
| |
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
| |
|
|
| C 1357
|
| M. Ndlazi
|
| Vol #:
|
| 233
|
| |
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
| |
|
|
| EMC 154
|
| S. Lovtang
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 155
|
| N. Kates
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 156
|
| K. Locke
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 157
|
| S. Ewig
|
| Vol #:
|
| 3
|
| |
|
|
| 2002E-0339
|
| Benicar, U.S. Patent No. 5,616,599
|
| |
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2002N-0275
|
| Bioterrorism Preparedness; Administrative Detention
|
| |
|
|
| EMC
87
|
| One Network Enterprises
|
| Vol #:
|
| 8
|
| |
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
| |
|
|
| EMC
142
|
| Hogan & Hartson, LLP
|
| Vol #:
|
| 20
|
| |
|
|
| 2002N-0277
|
| Bioterrorism; Establishment & Maintenance of Records
|
| |
|
|
| EMC
162
|
| One Network Enterprises
|
| Vol #:
|
| 16
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| EMC
166
|
| Hogan & Hartson, LLP
|
| Vol #:
|
| 22
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC 326
|
| Dr. B. Martini
|
| Vol #:
|
| 6
|
| |
|
|
| EMC
327
|
| Mission Possible International
|
| Vol #:
|
| 6
|
| |
|
|
| 2003D-0571
|
| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
|
| |
|
|
| C
2
|
| AstraZeneca Pharmaceuticals, LP
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0036
|
| Patent Extension Application for SPECTRACEF No. 4,839,350
|
| |
|
|
| LET
3
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0146
|
| Patent Extension Application for RELPAX, No. 5,545,644
|
|
| | | | | | | | |
| |
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0154
|
| Patent Term Extension of U.S. Patent #4,328,809
|
| |
|
|
| LET
1
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0243
|
| Patent Extension for InFuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device, 5,984,967
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0244
|
| Patent InFuse Bone Graft/LT-CAGE Lumbar Tapered Fusion Device, 5,782,919
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0402
|
| Patent Term Restoration Application for Acrysof, U.S. Patent No. 5,470,932
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0410
|
| Patent Term Restoration Application for Zubrin (tepoxalin), U.S. Patent No. 4,826,868
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0457
|
| Patent Extension, SOMAVERT, pegisomant for injection, #5,849,535
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| C 90
|
| Greg
|
| Vol #:
|
| 9
|
| |
|
|
| C 91
|
| J. Korsmo
|
| Vol #:
|
| 9
|
| |
|
|
| C 92
|
| J. Korsmo
|
| Vol #:
|
| 9
|
| |
|
|
| C 93
|
| J. Korsmo
|
| Vol #:
|
| 9
|
| |
|
|
| 2003P-0029
|
| Remove metered-dose inhalers (MDI) containing moiety albuter
|
| |
|
|
| C
7
|
| American Lung Association
|
| Vol #:
|
| 1
|
| |
|
|
| C
8
|
| Asthma Therapy Coalition (ATC)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0393
|
| Diazepam Injection USP, 5 mg/mL, 1-mL,(ANDA No. 72-079), by Abbott laboratories, Inc., has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
|
| |
|
|
| LET
1
|
| HFD-007 to PharmaForce, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0477
|
| Expedite the revocation of determination of the application of the AIP
|
| |
|
|
| LET
1
|
| HFZ-001 to Endotec
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0544
|
| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
|
| |
|
|
| C 33
|
| D. Hackett
|
| Vol #:
|
| 1
|
| |
|
|
| C 34
|
| E. Brooks
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
|
| | | | | | | | |
| |
|
|
| EMC 7
|
| H. Maio
|
| Vol #:
|
| 2
|
| |
|
|
| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
| |
|
|
| C
6
|
| National Organization for Women
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0028
|
| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
|
| |
|
|
| C 30
|
| 6 signatures
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 305
|
| R. Hill
|
| Vol #:
|
| 2
|
| |
|
|
| 2004D-0035
|
| Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
|
| |
|
|
| C
1
References
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0041
|
| Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling
|
| |
|
|
| EMC
2
|
| AstraZeneca Pharmaceuticals, LP
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
3
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0011
|
| Patenet Term Extention of U.S. patent No. 5,198,533 for Cetrotide (cetrorelix acetate)
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0019
|
| Patent Extension, FUZEON (enfuvirtide), U.S. Patent No. 6,133,418
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0023
|
| Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate )
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
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| Vol #:
|
| 1
|
| |
|
|
| 2004E-0039
|
| Patent Extension for CRESTOR (rosuvastatin), U.S. Patent No. RE37,314
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0040
|
| Patent Extension for CYDECTIN, U.S. Patent No. 4,916,154
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004M-0165
|
| H020008; OP-1 Putty
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| |
|
|
| AAV
1
|
| Stryker Biotech
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0049
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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|
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|
|
|
|
|
|
| C
3
|
| G. Seaberg
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
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| |
|
|
| APE 1
|
| Wimmer Systems, LLC
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0171
|
| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
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|
| | | | | | | | |
| |
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|
| ACK
1
|
| HFA-305 to Genentech, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Exhibit
1, 2,
3,
4
|
| Genentech, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004Q-0083
|
| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
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| |
|
|
| LET
1
|
| HFS-200 to Fleminger, Inc
|
| Vol #:
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| 8
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|
|
