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| Dockets Entered
On February 16, 2005
Table of Contents
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 1998N-0046
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| Comprehensive List of Current Guidance Documents at FDA
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| 2000D-1392
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| Guidance for Industry on Botanical Drug Products
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| 2000N-0504
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| Egg Safety Action Plan
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| 2000N-1409
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| Revision of the Identification of the Ionotophoresis
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| 2000P-1378
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| Cosmetic Products Containing Alpha Hydroxy Acids
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| 2003D-0474
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| Draft Guidance Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI (VICH GL-36)
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| 2003F-0535
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| Chlorine Dioxide (FAP 4A4751)
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2004D-0377
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| International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
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| |
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| 2004D-0443
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| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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| 2004D-0460
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| Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization
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| 2004D-0468
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| Draft Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for use in Animals
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| 2004D-0478
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| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information
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| 2004D-0484
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| Guidance for Industry on the Role of HIV Drug Resistance Testing in Antiretroviral Drug Development
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| 2004D-0509
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| Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association
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| 2004N-0033
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| Factor VIII Inhibitors
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| 2004N-0234
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| Annual Guidance Agenda
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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-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004N-0486
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Experimental Study of Health Claims on Food Packages
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| 2004N-0503
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| Agency Information Collection Activities: Proposed Collection; Comment Request: Guidance on Consultation Procedures; Foods Derived From New Plant Varieties
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| 2004N-0535
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| Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
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| 2004N-0559
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| Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
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| 2004P-0140
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| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
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| 2005N-0036
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| Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 2005P-0074
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| Chlorhexidine Gluconate 2% w/v and Isopropyl Acohol 70% v/v patient preoperative skin preparation 3 mL,in different dosage form suitable for ANDA
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| 2005V-0073
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| Laser Light Show
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| 1976N-0052N
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| OTC Nasal Decongestants
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|
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| EC 2
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| Concerned Citizens Against Drug Dealers
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| Vol #:
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| 77
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|
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| | | | | | | | |
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| EC 26
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| Mr. Enzo Marchese
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| Vol #:
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| 140
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| EC 27
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| USAFR (Ret)
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| Vol #:
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| 140
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| EREG 26
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| Conley, James
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| Vol #:
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| 140
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| EREG 27
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| Page, Karrie
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| Vol #:
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| 140
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| EREG 28
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| Mueller, William
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| Vol #:
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| 140
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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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| SUP
35
Attachment
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| Northfield Laboratories Inc BB IND 10719
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| Vol #:
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| 39
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| 1998N-0046
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| Comprehensive List of Current Guidance Documents at FDA
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|
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| NCR
2
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| FDA
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| Vol #:
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| 2
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| |
|
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| 2000D-1392
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| Guidance for Industry on Botanical Drug Products
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| EC
7
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| Senior Tai Chi Group of Michigan City
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| Vol #:
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| 2
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| |
|
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| 2000N-0504
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| Egg Safety Action Plan
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| C 378
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| S. Shoss
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| Vol #:
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| 32
|
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| 2000N-1409
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| Revision of the Identification of the Ionotophoresis
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|
| EC
2
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| IOMED, Inc.
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| Vol #:
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| 1
|
| |
|
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| 2000P-1378
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| Cosmetic Products Containing Alpha Hydroxy Acids
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|
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| EC 3
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| Ms. Wendy Fitos
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| Vol #:
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| 1
|
| |
|
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| 2003D-0474
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| Draft Guidance Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI (VICH GL-36)
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| |
|
|
| GDL
2
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| GUIDANCE
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| Vol #:
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| 1
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| |
|
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| |
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| 2003F-0535
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| Chlorine Dioxide (FAP 4A4751)
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| BKG
1
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| Background
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| Vol #:
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| 1
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| FONS
1
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| Findings of No Significant Impact
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| Vol #:
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| 1
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| |
|
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| NFR
1
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| FDA
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| Vol #:
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| 1
|
| |
|
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| |
|
|
| EAPE 9
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| Kahana, Jeri
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| Vol #:
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| 4
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| |
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| 2004D-0377
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| International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
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|
|
|
|
|
|
| |
|
|
| C
13
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| Pfizer, Inc.
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| Vol #:
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| 1
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| |
|
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| 2004D-0443
|
| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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|
| | | | | | | | |
|
| |
|
| C
17
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| Linde Gas, LLC
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| Vol #:
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| 2
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| |
|
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| 2004D-0460
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| Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization
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|
|
|
|
|
|
|
| EC
4
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| BATRA MEDICOS
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| Vol #:
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| 1
|
| |
|
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| 2004D-0468
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| Draft Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for use in Animals
|
|
|
|
|
|
|
|
|
| C
2
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| Norbrook, Inc.
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| Vol #:
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| 1
|
| |
|
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| 2004D-0478
|
| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information
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|
|
|
|
|
|
|
|
| EC
1
|
| OPR
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| Vol #:
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| 1
|
| |
|
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| 2004D-0484
|
| Guidance for Industry on the Role of HIV Drug Resistance Testing in Antiretroviral Drug Development
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| |
|
|
| C
1
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| Pfizer, Inc.
|
| Vol #:
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| 1
|
| |
|
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| 2004D-0509
|
| Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association
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| |
|
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| EC
2
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| East Coast Seafood Inc.
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| Vol #:
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| 1
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| EC
3
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| National Fisheries Institute
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| Vol #:
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| 1
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| EC
4
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| New England Lobster Exporters Coalition
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| Vol #:
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| 1
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| |
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| 2004N-0033
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| Factor VIII Inhibitors
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| |
|
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| EC 5
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| Dr. Stu Hyatt
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| Vol #:
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| 4
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| |
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| 2004N-0234
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| Annual Guidance Agenda
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|
|
| C
1
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| Advanced Medical Technology Assn (AdvaMed)
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| Vol #:
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| 1
|
| |
|
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| 2004N-0330
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| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
|
| |
|
|
| EC 57
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| Pittsburg State University
|
| Vol #:
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| 2
|
| |
|
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| 2004N-0454
|
| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
|
| |
|
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| C 31
|
| T. Tiedt, PhD
|
| Vol #:
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| 30
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| |
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| EC
79
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| Morning Star Center
|
| Vol #:
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| 31
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| |
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| EC 80
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| Dr. Vaughn Bowman, LLC
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| Vol #:
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| 31
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| |
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| EC 81
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| Mrs. Virginia Irvin
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| Vol #:
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| 31
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| |
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| EC 82
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| Mrs. Louise Spiers
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| Vol #:
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| 31
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| |
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| EC 83
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| Mr. Merwin Fuller
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| Vol #:
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| 31
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| |
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| EC
84
|
| Herbs and More
|
| Vol #:
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| 31
|
| |
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| EC
85
|
| Natural Health Consulting, LLC
|
| Vol #:
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| 31
|
| |
|
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| EC 86
|
| Ms. Adele Torreano
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| Vol #:
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| 31
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|
| | | | | | | |
| |
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| EC 87
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| Mrs. Kimberlee Gumz
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| Vol #:
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| 31
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| |
|
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| EC 88
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| Ms. Julie Geddes
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| Vol #:
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| 31
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| |
|
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| EC 89
|
| Mrs. Mary Myers
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| Vol #:
|
| 31
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| |
|
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| EC 90
|
| Mrs. Robyn Trog
|
| Vol #:
|
| 31
|
| |
|
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| EC
91
|
| The Natural Health Consultant, Inc.
|
| Vol #:
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| 31
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| |
|
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| EC 92
|
| Mrs. Gerlinde Pizzuto
|
| Vol #:
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| 31
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| |
|
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| EC 93
|
| Mrs. Jean Wojcik
|
| Vol #:
|
| 31
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| |
|
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| EC 94
|
| Mr. Thomas Anstett
|
| Vol #:
|
| 31
|
| |
|
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| EC 95
|
| Miss. Patricia Merlino
|
| Vol #:
|
| 31
|
| |
|
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| EC
96
|
| Holistic Services
|
| Vol #:
|
| 31
|
| |
|
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| EC
97
|
| MOMS
|
| Vol #:
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| 31
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| |
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| EC 98
|
| Mr. Paul Rabalais
|
| Vol #:
|
| 31
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| |
|
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| EC 99
|
| Mrs. Kimberly Fiucci
|
| Vol #:
|
| 31
|
| |
|
|
| EC 100
|
| Dr. Laura McCready
|
| Vol #:
|
| 31
|
| |
|
|
| EC
101
|
| waves of wellness
|
| Vol #:
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| 31
|
| |
|
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| EC 102
|
| Mrs. Kathryn Lubecke
|
| Vol #:
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| 31
|
| |
|
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| EC 103
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| Mrs. Betty Mc Mullan
|
| Vol #:
|
| 31
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| |
|
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| EC 104
|
| Ms. Tracy VandenHeuvel
|
| Vol #:
|
| 31
|
| |
|
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| EC
105
|
| Nature's Remdy
|
| Vol #:
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| 31
|
| |
|
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| EC
106
|
| whole healthcare
|
| Vol #:
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| 31
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| |
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| EC 107
|
| Dr. Carma Carlson
|
| Vol #:
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| 31
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| |
|
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| EC 108
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| Mr. Thomas Ferrante
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| Vol #:
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| 31
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| |
|
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| EC 109
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| Mrs. Ann Hoida
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| Vol #:
|
| 31
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| |
|
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| EC 110
|
| Ms. J. A. Kretz, M.S.
|
| Vol #:
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| 31
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| |
|
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| EC
111
|
| Enlightened Energy
|
| Vol #:
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| 31
|
| |
|
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| EC
112
|
| Nature's Healthy Garden, INC
|
| Vol #:
|
| 31
|
| |
|
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| EC
113
|
| Senlite Corporation
|
| Vol #:
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| 31
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| |
|
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| EC 114
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| Mrs. Barb Webb
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| Vol #:
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| 31
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| |
|
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| EC 115
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| Mrs. Dolores Klingeisen
|
| Vol #:
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| 31
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| |
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| EC 116
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| Ms. Richelle Jarrell
|
| Vol #:
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| 31
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| |
|
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| EC 117
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| Mr. Lester Klingeisen
|
| Vol #:
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| 31
|
| |
|
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| EC 118
|
| Mr. Richard Klingeisen
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| Vol #:
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| 31
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| |
|
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| EC 119
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| Ms. Adrienne McNab
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| Vol #:
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| 31
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| |
|
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| EC 120
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| Mrs. Marilyn De Moss
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| Vol #:
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| 31
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| |
|
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| EC 121
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| Ms. Lourdes Fukushima
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| Vol #:
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| 31
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| |
|
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| EC 122
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| Mrs. Phyllis Young
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| Vol #:
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| 31
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| |
|
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| EC 123
|
| Mrs. kerra Hayes
|
| Vol #:
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| 31
|
|
| | | | | | | |
| |
|
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| EC
124
|
| Louisiana Health Freedom Coalition
|
| Vol #:
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| 31
|
| |
|
|
| EC 125
|
| Mrs. Virginia Styles
|
| Vol #:
|
| 31
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| |
|
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| EC 126
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| Mrs. Shelli Dimig
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| Vol #:
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| 31
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| |
|
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| EC 127
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| Mr. Michael Sutton
|
| Vol #:
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| 31
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| |
|
|
| EC 128
|
| Mrs. Henrieta Ribeiro
|
| Vol #:
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| 31
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| |
|
|
| EC 129
|
| Ms. Connie Harmon
|
| Vol #:
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| 31
|
| |
|
|
| EC
130
|
| Health
|
| Vol #:
|
| 31
|
| |
|
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| EC 131
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| Mrs. Deborah Measel
|
| Vol #:
|
| 31
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| |
|
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| EC 132
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| Mrs. Virginia Stafford
|
| Vol #:
|
| 31
|
| |
|
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| EC 133
|
| N/A
|
| Vol #:
|
| 31
|
| |
|
|
| EC 134
|
| Ms. Diane Vandermuse
|
| Vol #:
|
| 31
|
| |
|
|
| EC 135
|
| Mrs. Anna Extine
|
| Vol #:
|
| 31
|
| |
|
|
| EC 136
|
| Ms. Doris Sakler
|
| Vol #:
|
| 31
|
| |
|
|
| EC 137
|
| Mrs. Nicole Bandes
|
| Vol #:
|
| 31
|
| |
|
|
| EC 138
|
| Mrs. Sharlotte Holiman
|
| Vol #:
|
| 31
|
| |
|
|
| EC
139
|
| A-1 Health Marketing Co.
|
| Vol #:
|
| 31
|
| |
|
|
| EC
140
|
| West Side Holistic Center
|
| Vol #:
|
| 31
|
| |
|
|
| EC 141
|
| Mrs. Linda Shipley
|
| Vol #:
|
| 31
|
| |
|
|
| EC 142
|
| Mr. John Nutt
|
| Vol #:
|
| 31
|
| |
|
|
| EC
143
|
| Herb Lady of Cave Creek
|
| Vol #:
|
| 31
|
| |
|
|
| EC 144
|
| Ms. Jane Kraemer
|
| Vol #:
|
| 31
|
| |
|
|
| EC 145
|
| Mr. Fred Marshall
|
| Vol #:
|
| 31
|
| |
|
|
| EC
146
|
| Alternative Health Center
|
| Vol #:
|
| 31
|
| |
|
|
| EC 147
|
| Mrs. Donna Watkins
|
| Vol #:
|
| 31
|
| |
|
|
| EC
148
|
| NAHC
|
| Vol #:
|
| 31
|
| |
|
|
| EC 149
|
| none
|
| Vol #:
|
| 31
|
| |
|
|
| EC 150
|
| Ms. Kathleen Donatelle
|
| Vol #:
|
| 31
|
| |
|
|
| EC 151
|
| Mr. Donald Young
|
| Vol #:
|
| 31
|
| |
|
|
| EC
152
|
| Beysouth
|
| Vol #:
|
| 31
|
| |
|
|
| EC
153
|
| Sanctuary Yoga LLC
|
| Vol #:
|
| 31
|
| |
|
|
| EC 154
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| Mrs. tracy sirna
|
| Vol #:
|
| 31
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| |
|
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| EC 155
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| Mrs. Kathleen Lacey
|
| Vol #:
|
| 31
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| |
|
|
| EC
156
|
| Healthy Alternatinves Massage and Skin care
|
| Vol #:
|
| 31
|
| |
|
|
| EC 157
|
| Ms. Mary Ellen Kiel
|
| Vol #:
|
| 31
|
| |
|
|
| EC 158
|
| Mrs. Joann Grandstaff
|
| Vol #:
|
| 31
|
| |
|
|
| EC 159
|
| self
|
| Vol #:
|
| 31
|
| |
|
|
| EC 160
|
| Mrs. jerlean simmons
|
| Vol #:
|
| 31
|
|
| | | | | | | |
| |
|
|
| EC 161
|
| Ms. Barb Erte;
|
| Vol #:
|
| 31
|
| |
|
|
| EC
162
|
| Shaklee
|
| Vol #:
|
| 31
|
| |
|
|
| EC 163
|
| Dr. Terry Reed
|
| Vol #:
|
| 31
|
| |
|
|
| EC
164
|
| Horizon Diabetes Institute
|
| Vol #:
|
| 31
|
| |
|
|
| EC 165
|
| Dr. Bob Willhite, A.M.P.
|
| Vol #:
|
| 31
|
| |
|
|
| EC 166
|
| Mrs. Renee Place
|
| Vol #:
|
| 31
|
| |
|
|
| EC
167
|
| Herbal Alternatives
|
| Vol #:
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| 31
|
| |
|
|
| EC 168
|
| Mrs. Christine Kieffer
|
| Vol #:
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| 31
|
| |
|
|
| EC 169
|
| Ms. Michele Uhl Born
|
| Vol #:
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| 31
|
| |
|
|
| EC 170
|
| Mrs. Sharon Tsui
|
| Vol #:
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| 31
|
| |
|
|
| EC
171
|
| NAHC
|
| Vol #:
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| 31
|
| |
|
|
| EC
172
|
| Sierra Oaks
|
| Vol #:
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| 31
|
| |
|
|
| EC 173
|
| Dr. Dave Carpenter
|
| Vol #:
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| 31
|
| |
|
|
| EC 174
|
| Mrs. Richelle Massengale
|
| Vol #:
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| 31
|
| |
|
|
| EC
175
|
| Alternative Health Solutions
|
| Vol #:
|
| 31
|
| |
|
|
| EC 176
|
| Ms. Sarah Rothschild
|
| Vol #:
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| 31
|
| |
|
|
| EC 177
|
| Mrs. Jennifer Smith
|
| Vol #:
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| 31
|
| |
|
|
| EC 178
|
| Mrs. Sharon Good
|
| Vol #:
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| 31
|
| |
|
|
| EC 179
|
| none
|
| Vol #:
|
| 31
|
| |
|
|
| EC
180
|
| Neurogenesis, Inner Light
|
| Vol #:
|
| 31
|
| |
|
|
| EC 181
|
| self
|
| Vol #:
|
| 31
|
| |
|
|
| EC 182
|
| Mr. Craig Vandenberg
|
| Vol #:
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| 31
|
| |
|
|
| EC 183
|
| Mrs. Rose Benjamin
|
| Vol #:
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| 31
|
| |
|
|
| EC 184
|
| Ms. Brenda Smith
|
| Vol #:
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| 31
|
| |
|
|
| EC 185
|
| Mrs. Cheryl Potter
|
| Vol #:
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| 31
|
| |
|
|
| EC 186
|
| Mrs. Evelyn Record
|
| Vol #:
|
| 31
|
| |
|
|
| EC 187
|
| Mr. Ralph Sutley
|
| Vol #:
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| 31
|
| |
|
|
| EC 188
|
| Mrs. Kathryn Clark
|
| Vol #:
|
| 31
|
| |
|
|
| EC 189
|
| Ms. Judith Sutley
|
| Vol #:
|
| 31
|
| |
|
|
| EC
190
|
| Herbs To Go
|
| Vol #:
|
| 31
|
| |
|
|
| EC
191
|
| Betterherbs
|
| Vol #:
|
| 31
|
| |
|
|
| EC 192
|
| Ms. Deborah Markoski
|
| Vol #:
|
| 31
|
| |
|
|
| EC 193
|
| Independent
|
| Vol #:
|
| 31
|
| |
|
|
| EC 194
|
| Mr. Anthony Lagana
|
| Vol #:
|
| 31
|
| |
|
|
| EC 195
|
| Ms. Connie Baum
|
| Vol #:
|
| 31
|
| |
|
|
| EC 196
|
| Mr. De Veau Dunn
|
| Vol #:
|
| 31
|
| |
|
|
| EC 197
|
| Ms. Connie Baum
|
| Vol #:
|
| 31
|
|
| | | | | | | | |
| |
|
|
| EC 198
|
| Mrs. Carol Wagar
|
| Vol #:
|
| 31
|
| |
|
|
| EC 199
|
| Ms. suzanne seely
|
| Vol #:
|
| 31
|
| |
|
|
| EC 200
|
| Mr. Howard Lane
|
| Vol #:
|
| 31
|
| |
|
|
| EC 201
|
| Mr. Howard Lane
|
| Vol #:
|
| 31
|
| |
|
|
| EC 202
|
| Mr. Carl Schmidt
|
| Vol #:
|
| 31
|
| |
|
|
| EC 203
|
| Mrs. Kathleen Neuman
|
| Vol #:
|
| 31
|
| |
|
|
| EC 204
|
| Mrs. neva russell
|
| Vol #:
|
| 31
|
| |
|
|
| EC 205
|
| Mr. Dennis Ebert
|
| Vol #:
|
| 31
|
| |
|
|
| EC 206
|
| Mrs. Rosella Hill
|
| Vol #:
|
| 31
|
| |
|
|
| EC 207
|
| Mrs. Frannie Gardner
|
| Vol #:
|
| 31
|
| |
|
|
| EC 208
|
| Mrs. Kristen Angermeier
|
| Vol #:
|
| 31
|
| |
|
|
| EC 209
|
| Ms. Danna Spayde
|
| Vol #:
|
| 31
|
| |
|
|
| EC 210
|
| Dr. Martha Kliesh
|
| Vol #:
|
| 31
|
| |
|
|
| EC 211
|
| Mrs. b.g. smith
|
| Vol #:
|
| 31
|
| |
|
|
| EC 212
|
| Mrs. Neda Herman
|
| Vol #:
|
| 31
|
| |
|
|
| EC
213
|
| Florida Chapter of Certified Natural Health Profes
|
| Vol #:
|
| 31
|
| |
|
|
| EC 214
|
| Mr. Frank Nelms
|
| Vol #:
|
| 31
|
| |
|
|
| EC 215
|
| Ms. Joyce Soran
|
| Vol #:
|
| 31
|
| |
|
|
| EC 216
|
| Mrs. Celia Madden
|
| Vol #:
|
| 31
|
| |
|
|
| EC 217
|
| Mrs. LeLena Erb
|
| Vol #:
|
| 31
|
| |
|
|
| EC 218
|
| Mrs. Linda Yates
|
| Vol #:
|
| 31
|
| |
|
|
| EC 219
|
| Mrs. Jolyn Henricksen
|
| Vol #:
|
| 31
|
| |
|
|
| EC 220
|
| Mr. ALFRED JOHNSON
|
| Vol #:
|
| 31
|
| |
|
|
| EC 221
|
| Ms. Donna Haag
|
| Vol #:
|
| 31
|
| |
|
|
| EC 222
|
| Mrs. Sarah Newfield
|
| Vol #:
|
| 31
|
| |
|
|
| EC
223
|
| Everlasting Health
|
| Vol #:
|
| 31
|
| |
|
|
| EC 224
|
| Mr. Hans Frischeisen
|
| Vol #:
|
| 31
|
| |
|
|
| EC 225
|
| Ms. Sue Dyer
|
| Vol #:
|
| 31
|
| |
|
|
| EC 226
|
| Ms. Anita Barnett
|
| Vol #:
|
| 31
|
| |
|
|
| EC 227
|
| Mrs. Marlie Dailey
|
| Vol #:
|
| 31
|
| |
|
|
| EC 228
|
| Mrs. Marlie Daiely
|
| Vol #:
|
| 31
|
| |
|
|
| EC 229
|
| Mrs. Linda Mulhall
|
| Vol #:
|
| 31
|
| |
|
|
| EC 230
|
| Self
|
| Vol #:
|
| 31
|
| |
|
|
| 2004N-0486
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Experimental Study of Health Claims on Food Packages
|
| |
|
|
| EC
1
|
| International Dairy Foods Association
|
| Vol #:
|
| 1
|
| |
|
|
| EC
2
|
| International Dairy Foods Association
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| EC
3
|
| Kraft Foods Global, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0503
|
| Agency Information Collection Activities: Proposed Collection; Comment Request: Guidance on Consultation Procedures; Foods Derived From New Plant Varieties
|
| |
|
|
| EC 3
|
| Mr. Joshua Broberg
|
| Vol #:
|
| 17
|
| |
|
|
| EC 4
|
| Dr. Michael Phillips
|
| Vol #:
|
| 1
|
| |
|
|
| EC 5
|
| Dr. Michael Phillips
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0535
|
| Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
|
| |
|
|
| EC
1
|
| Erie VA Medical Center
|
| Vol #:
|
| 1
|
| |
|
|
| EC
2
|
| Hoffmann-La Roche Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0559
|
| Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
|
| |
|
|
| C 10
|
| M. Hooper
|
| Vol #:
|
| 2
|
| |
|
|
| 2004P-0140
|
| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
|
| |
|
|
| SUP
4
Attached CV
|
| Mutual Pharmaceutical Co., Inc. (Mutual)
|
| Vol #:
|
| 5
|
| |
|
|
| 2005N-0036
|
| Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
|
| |
|
|
| APE 4
|
| Institute for Safe Medication Practices (ISMP)
|
| Vol #:
|
| 1
|
| |
|
|
| APE 5
|
| Institute for Safe Medication Practices (ISMP)
|
| Vol #:
|
| 1
|
| |
|
|
| APE 6
|
| USP Standards Development
|
| Vol #:
|
| 1
|
| |
|
|
| APE 7
|
| American Health Packaging
|
| Vol #:
|
| 1
|
| |
|
|
| APE 8
|
| American Society of Health-System Pharmacists (ASHP)
|
| Vol #:
|
| 1
|
| |
|
|
| APE 9
|
| Hospira, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| APE 10
|
| Pfizer Inc
|
| Vol #:
|
| 1
|
| |
|
|
| APE 11
|
| AstraZeneca Pharmaceuticals
|
| Vol #:
|
| 1
|
| |
|
|
| APE 12
|
| American Academy of Ophthalmology
|
| Vol #:
|
| 1
|
| |
|
|
| EC
1
Page
2, Page
3, Page
4
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0038
|
| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
|
| |
|
|
| APE 2
|
| Bausch & Lomb, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 56
|
| Higgins, Melody
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 57
|
| Toomey, MaryAnn
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 58
|
| Cody, Marisue
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 59
|
| Johnstone, Karen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 60
|
| Rineer, Nikki
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 61
|
| Humes, Eric
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 62
|
| Braun, Sandra
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 63
|
| Noone, Michael
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| EAPE 64
|
| Birmingham, William
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 65
|
| Dugan, Jennifer
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 66
|
| Seidman, Madeleine
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 67
|
| Donnelly, Janet
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0074
|
| Chlorhexidine Gluconate 2% w/v and Isopropyl Acohol 70% v/v patient preoperative skin preparation 3 mL,in different dosage form suitable for ANDA
|
| |
|
|
| ACK
1
|
| HFA-305 to Aplicare, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Aplicare, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2005V-0073
|
| Laser Light Show
|
| |
|
|
| ACK
1
|
| HFA-305 to William McHugh
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| William McHugh
|
| Vol #:
|
| 1
|
|
|
