| | | | | | | | | | |
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| Dockets Entered On November
28, 2006
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| Docket #
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| Title
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| 1978N-0065
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| Skin Bleaching Drug Products
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| |
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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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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| 2002P-0122
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| Request Rulemaking on Functional Foods & Establish Adv. Com.
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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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| 2005D-0310
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| Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
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| |
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| |
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| |
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| |
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| 2006D-0303
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| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
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| |
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| |
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| |
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| 2006N-0314
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| Proposal to Debar Lawrence Kozlowski, Notice of Opportunity for Hearing
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| |
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| |
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| 2006N-0378
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| Review of Agreements, Guidances, and Practices Specific to Assignment of Combination Products in Compliance with the Medical Device User Fee and Modernization Act of 2002
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| |
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| 2006N-0414
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| Suicidality Data from Adult Antidepressant Trials
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| |
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| 2006N-0464
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| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
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| |
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| 2006P-0393
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| Health Claim Petition: Barley Betafiber and Coronary Heart Disease
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| |
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| |
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| 2006P-0477
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| ANDA for potassium chloride oral solution drug products in strengths of 10% and 5%
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| 1978N-0065
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| Skin Bleaching Drug Products
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| |
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| C 38
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| B. Caruthers Jr., M.D.
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| Vol #:
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| 15
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| |
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| C 39
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| T. Batie
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| Vol #:
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| 15
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| |
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| C 40
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| AgeDefying Dermatology
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| Vol #:
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| 15
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| |
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| C 41
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| AgeDefying Dermatology
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| Vol #:
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| 15
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| |
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| EC 98
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| ASDS
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| Vol #:
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| 14
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| |
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| EXT 3
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| Prescription Hydroquinone Task Force (Rx HQ Task Force)
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| Vol #:
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| 15
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| |
|
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| |
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| EC 1
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| Mr. Charles Smith
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| Vol #:
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| 8
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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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| EMC 806
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| J.
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| Vol #:
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| 33
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| |
|
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| 2002P-0122
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| Request Rulemaking on Functional Foods & Establish Adv. Com.
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| | | | | | | | |
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| |
|
| EC 1
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| National Consumers League
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| Vol #:
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| 1
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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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| EMC 1386
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| A. Martin
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| Vol #:
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| 12
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| |
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| EMC 1387
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| A.
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| Vol #:
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| 12
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| |
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| 2005D-0310
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| Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
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| |
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| BKG 2
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| Background Material
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| Vol #:
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| 3
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| |
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| |
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| EXB 53
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| R-48 Label 1-086 TMJ Patient Information
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| Vol #:
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| 57
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| |
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| EXB 54
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| R-49 Label 2-028 Surgeon's Instruction Manual
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| Vol #:
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| 58
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| |
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| EXB 55
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| R-50 TMJ Implants, Inc. Product Description
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| Vol #:
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| 59
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| |
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| EXB 56
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| R-51 ( 1 of 2) TMJ Implants, Inc. Clinical Data, Bibliography
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| Vol #:
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| 60
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| |
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| EXB 57
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| R-51 (2 of 2) TMJ Implants, Inc. Clinical Data, Bibliography
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| Vol #:
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| 61
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| |
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| EXB 58
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| R-52 TMJournal
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| Vol #:
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| 62
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| |
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| EXB 59
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| R-53 (1 of 2) Annual Reports
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| Vol #:
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| 63
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| |
|
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| EXB 60
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| R-53 (2 of 2) Annual Reports
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| Vol #:
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| 64
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| |
|
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| EXB 61
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| R-54 FDA's TMJ Consumer Update
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| Vol #:
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| 65
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| |
|
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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|
|
|
|
|
|
|
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| C 8
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| National Association of Foreign-Trade Zones
|
| Vol #:
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| 3
|
| |
|
|
| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| |
|
|
| EMC 4145
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| W. Cunningham
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| Vol #:
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| 195
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| |
|
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| EMC 4146
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| R. Klatz
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| Vol #:
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| 195
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| |
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| EMC 4147
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| M. Floyd
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| Vol #:
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| 195
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| |
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| EMC 4148
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| R. Yankevicz
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| Vol #:
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| 195
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| |
|
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| EMC 4149
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| P. Miller
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| Vol #:
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| 195
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| |
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| EMC 4150
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| D. Nitz
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| Vol #:
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| 195
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| |
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| EMC 4151
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| M. LeBlanc
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| Vol #:
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| 195
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| |
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| EMC 4152
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| J. Zebrook
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| Vol #:
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| 195
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| |
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| EMC 4153
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| K. Wright
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| Vol #:
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| 195
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| |
|
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| 2006D-0303
|
| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
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| |
|
|
| C 8
|
| Medi-Flex, Inc. (Medi-Flex)
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| Vol #:
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| 1
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| |
|
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| EMC 1
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| Biotechnology Industry Organization
|
| Vol #:
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| 1
|
| |
|
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| EMC 2
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| Pfizer, Inc.
|
| Vol #:
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| 1
|
|
| | | | | | | | |
|
| |
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| 2006D-0331
|
| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
|
| |
|
|
| EC 66
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| Villanova University School of Law -- Student
|
| Vol #:
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| 3
|
| |
|
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| EC 67
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| Wayne State University SOM
|
| Vol #:
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| 3
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| |
|
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| EC 68
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| Baylor College of Medicine
|
| Vol #:
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| 3
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| |
|
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| EC 69
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| Medical Device Manufacturers Association
|
| Vol #:
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| 3
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| |
|
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| EC 70
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| Eastern Association for the Surgery of Trauma
|
| Vol #:
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| 3
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| |
|
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| EC 71
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| Public Responsibility in Medicine and Research
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| Vol #:
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| 3
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| |
|
|
| EMC 4
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| National Institute of Health-Office of Biotechnology Activities-Office of Science Policy
|
| Vol #:
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| 3
|
| |
|
|
| 2006D-0383
|
| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
|
|
|
|
|
|
|
|
|
| C 133
|
| P. Tew
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| Vol #:
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| 9
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| |
|
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| C 134
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| E. Ursell
|
| Vol #:
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| 9
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| |
|
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| C 135
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| M and T Hourigan
|
| Vol #:
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| 9
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| |
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| EC 2194
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| Mr. Philip Gama
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| Vol #:
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| 8
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| |
|
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| EC 2195
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| Mrs. Nancy Prochaska
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| Vol #:
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| 8
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| |
|
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| EC 2196
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| Mr. Richard J. Rolwing
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| Vol #:
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| 8
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| |
|
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| EC 2197
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| Dr. Jeremy Slagley
|
| Vol #:
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| 8
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| |
|
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| EC 2198
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| Mrs. Kathleen Bohman
|
| Vol #:
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| 8
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| |
|
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| EC 2199
|
| Catholic FertilityCare Center of WNY
|
| Vol #:
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| 8
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| |
|
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| EC 2200
|
| Mrs. Gina Hull
|
| Vol #:
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| 8
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| |
|
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| EC 2201
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| Mr. Alexander Pocetto
|
| Vol #:
|
| 8
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| |
|
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| EC 2202
|
| Miss. Therese Schreck
|
| Vol #:
|
| 8
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| |
|
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| EC 2203
|
| Mrs. Shelly Dickinson
|
| Vol #:
|
| 8
|
| |
|
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| EC 2204
|
| Christian
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2205
|
| Mrs. Deanna Parish
|
| Vol #:
|
| 8
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| |
|
|
| EC 2206
|
| Mrs. Beth Poley
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2207
|
| Mrs. Angelica DeJolie
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2208
|
| Ms. Karen Petit
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2209
|
| St. Matthew Catholic Church
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2210
|
| Miss. Anne Moody
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2211
|
| Mrs. Marie Possel
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2212
|
| Mr. Francis Whiting
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2213
|
| Mr. Gerald Shanks
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2214
|
| Dr. David Zelis
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2215
|
| Physical Therapist
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2216
|
| Mrs. I.Margarita Rivera
|
| Vol #:
|
| 8
|
|
| | | | | | | |
|
| |
|
| EC 2217
|
| Mrs. Deborah Collier
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2218
|
| Mr. Carmen Priola
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2219
|
| Mrs. Michelle L. Jones
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2220
|
| Mrs. Noreen Vozzo
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2221
|
| Mrs. Joanne Florini
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2222
|
| Mr. Jeremy Priest
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2223
|
| Mrs. Barb LeGrave
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2224
|
| Mrs. jenni Cory
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2225
|
| Mr. Daniel Lee
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2226
|
| Mrs. marlene mantey
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2227
|
| Ms. Elizabeth Lawton
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2228
|
| Mr. Don Evrard
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2229
|
| Mrs. Mary Moore
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2230
|
| Mr. Nicholas Ferreira
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2231
|
| Mr. Chad Cmejla
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2232
|
| Mrs. Jeannie McNaughton
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2233
|
| Mr. Bradley Bennett
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2234
|
| Mrs. Maria Barnard
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2235
|
| Mr. Eric Kline
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2236
|
| Mr. Omar Syed
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2237
|
| Mr. Louis DeReuil
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2238
|
| Miss. Araceli Casas
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2239
|
| Mr. David Damiano
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2240
|
| Mrs. Joan Hosek
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2241
|
| Mrs. Emily Galuska
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2242
|
| Dr. Richard Tester
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2243
|
| Mrs. Nicola Cougher
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2244
|
| Dr. Peter Zimmer
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2245
|
| Mrs. Kristin Zimmer
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2246
|
| Mrs. Olivia Denahy
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2247
|
| Mrs. Kristine DeReuil
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2248
|
| Ms. Allison Faugot
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2249
|
| Mrs. Patricia Vaitkus,R.N.,BSN
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2250
|
| Miss. Emily Onellion
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2251
|
| Mr. Kenneth Reed
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2252
|
| Mrs. Paulette Valdez
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2253
|
| Mr. William Davis
|
| Vol #:
|
| 8
|
|
| | | | | | | | |
|
| |
|
| EMC 1
|
| K. Gilmore
|
| Vol #:
|
| 10
|
| |
|
|
| EMC 2
|
| C. Shroyer
|
| Vol #:
|
| 10
|
|
| |
|
| 2006N-0314
|
| Proposal to Debar Lawrence Kozlowski, Notice of Opportunity for Hearing
|
| |
|
|
| HER 1
|
| S. Rabaut
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0352
|
| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
|
| |
|
|
| C 449
|
| N. Frezados
|
| Vol #:
|
| 27
|
| |
|
|
| C 450
|
| J. Buys
|
| Vol #:
|
| 27
|
| |
|
|
| C 451
|
| M. Newell
|
| Vol #:
|
| 27
|
| |
|
|
| C 452
|
| P. Taylor
|
| Vol #:
|
| 27
|
| |
|
|
| C 453
|
| W. Glaros, DDS
|
| Vol #:
|
| 27
|
| |
|
|
| C 454
|
| P. HAttemer
|
| Vol #:
|
| 27
|
| |
|
|
| C 455
|
| K. Rose
|
| Vol #:
|
| 27
|
| |
|
|
| C 456
|
| E. Green, DMD
|
| Vol #:
|
| 27
|
| |
|
|
| C 457
|
| V. Buys
|
| Vol #:
|
| 27
|
| |
|
|
| C 458
|
| V. Buys
|
| Vol #:
|
| 27
|
| |
|
|
| C 459
|
| M. Woo, DDS
|
| Vol #:
|
| 27
|
| |
|
|
| C 460
|
| S/ D.C., N.D.
|
| Vol #:
|
| 27
|
| |
|
|
| C 461
|
| L. Hylander
|
| Vol #:
|
| 26
|
| |
|
|
| C 462
|
| C. Dohrenwend
|
| Vol #:
|
| 27
|
| |
|
|
| C 463
|
| I. Poole
|
| Vol #:
|
| 27
|
| |
|
|
| C 464
|
| R. Clarke
|
| Vol #:
|
| 27
|
| |
|
|
| C 465
|
| Dr. M. Baylin
|
| Vol #:
|
| 27
|
| |
|
|
| C 466
|
| L. George
|
| Vol #:
|
| 27
|
| |
|
|
| C 467
|
| B. Wrigth
|
| Vol #:
|
| 27
|
| |
|
|
| C 468
|
| D. Satloff
|
| Vol #:
|
| 27
|
| |
|
|
| C 469
|
| J. Sefcik, DDS
|
| Vol #:
|
| 27
|
| |
|
|
| C 470
|
| F. Hohn, DDS
|
| Vol #:
|
| 27
|
| |
|
|
| C 471
|
| D. Lerner, DDS
|
| Vol #:
|
| 27
|
| |
|
|
| C 472
|
| J. Viglielmo, DDS, AIAOMT
|
| Vol #:
|
| 27
|
| |
|
|
| C 473
|
| M. Grinovics
|
| Vol #:
|
| 27
|
| |
|
|
| C 474
|
| J. Canady
|
| Vol #:
|
| 27
|
| |
|
|
| C 475
|
| M. Pyle
|
| Vol #:
|
| 27
|
| |
|
|
| C 476
|
| C. McPherson
|
| Vol #:
|
| 27
|
| |
|
|
| C 477
|
| D. Oelkers
|
| Vol #:
|
| 27
|
| |
|
|
| C 478
|
| C. Spencer
|
| Vol #:
|
| 27
|
|
| | | | | | | |
|
| |
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| C 479
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| J. TAsker
|
| Vol #:
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| 27
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| |
|
|
| C 480
|
| No signature
|
| Vol #:
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| 27
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| |
|
|
| C 481
|
| S. Richardson
|
| Vol #:
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| 27
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| |
|
|
| C 482
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| A. BAunach
|
| Vol #:
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| 27
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| |
|
|
| C 483
|
| D. Neerman
|
| Vol #:
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| 27
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| |
|
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| C 484
|
| D. Martin
|
| Vol #:
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| 27
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| |
|
|
| C 485
|
| P. Ambrose
|
| Vol #:
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| 27
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| |
|
|
| C 486
|
| S. Beazley
|
| Vol #:
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| 27
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| |
|
|
| C 487
|
| M. McGill
|
| Vol #:
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| 27
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| |
|
|
| C 488
|
| J. Tarling
|
| Vol #:
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| 27
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| |
|
|
| C 489
|
| K. Cook
|
| Vol #:
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| 27
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| |
|
|
| C 490
|
| S. Carol
|
| Vol #:
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| 27
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| |
|
|
| C 491
|
| A. Wagner
|
| Vol #:
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| 27
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| |
|
|
| C 492
|
| T. Agranat
|
| Vol #:
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| 27
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| |
|
|
| C 493
|
| T. Palluzzi
|
| Vol #:
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| 27
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| |
|
|
| C 494
|
| R. Schmidt
|
| Vol #:
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| 27
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| |
|
|
| C 495
|
| C. Wooten
|
| Vol #:
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| 27
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| |
|
|
| C 496
|
| V. Rangamani
|
| Vol #:
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| 27
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| |
|
|
| C 497
|
| D. Sperber
|
| Vol #:
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| 27
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| |
|
|
| C 498
|
| R. Koss
|
| Vol #:
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| 27
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| |
|
|
| C 499
|
| P. Gray
|
| Vol #:
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| 27
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| |
|
|
| C 500
|
| D. McCamman
|
| Vol #:
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| 27
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| |
|
|
| C 501
|
| D. Martin
|
| Vol #:
|
| 27
|
| |
|
|
| C 502
|
| DAMS, Intl
|
| Vol #:
|
| 27
|
| |
|
|
| C 503
|
| T. Gordon
|
| Vol #:
|
| 27
|
| |
|
|
| C 504
|
| DAMS, Intl
|
| Vol #:
|
| 27
|
| |
|
|
| C 505
|
| G. Weeks
|
| Vol #:
|
| 27
|
| |
|
|
| C 506
|
| Dr. Gastaldo
|
| Vol #:
|
| 27
|
| |
|
|
| C 507
|
| R. Lang
|
| Vol #:
|
| 27
|
| |
|
|
| C 508
|
| J. Cali
|
| Vol #:
|
| 27
|
| |
|
|
| C 509
|
| J. Siles
|
| Vol #:
|
| 27
|
| |
|
|
| C 510
|
| DAMS, Intl
|
| Vol #:
|
| 27
|
| |
|
|
| C 511
|
| M. Haines
|
| Vol #:
|
| 27
|
| |
|
|
| C 512
|
| No signature
|
| Vol #:
|
| 27
|
| |
|
|
| C 513
|
| K. Foster
|
| Vol #:
|
| 27
|
| |
|
|
| C 514
|
| L. Graham
|
| Vol #:
|
| 27
|
| |
|
|
| C 515
|
| E. Rubio
|
| Vol #:
|
| 27
|
|
| | | | | | | |
|
| |
|
| C 516
|
| S. Stefanec
|
| Vol #:
|
| 27
|
| |
|
|
| C 517
|
| J. Johnston
|
| Vol #:
|
| 27
|
| |
|
|
| C 518
|
| G. Marsch
|
| Vol #:
|
| 27
|
| |
|
|
| C 519
|
| Law Offices of Mary Elloian
|
| Vol #:
|
| 27
|
| |
|
|
| C 520
|
| G. Mouser
|
| Vol #:
|
| 26
|
| |
|
|
| C 521
|
| J. Poole
|
| Vol #:
|
| 27
|
| |
|
|
| C 522
|
| P. Donwen
|
| Vol #:
|
| 27
|
| |
|
|
| C 523
|
| DAMS, Intl
|
| Vol #:
|
| 27
|
| |
|
|
| C 524
|
| B. Swanson
|
| Vol #:
|
| 27
|
| |
|
|
| C 525
|
| S. Collins, L.Ac
|
| Vol #:
|
| 27
|
| |
|
|
| C 526
|
| M. Smith
|
| Vol #:
|
| 27
|
| |
|
|
| C 527
|
| E. Adams
|
| Vol #:
|
| 27
|
| |
|
|
| C 528
|
| L. Joy
|
| Vol #:
|
| 27
|
| |
|
|
| C 529
|
| DAMS, Intl
|
| Vol #:
|
| 27
|
| |
|
|
| C 530
|
| G. Foster
|
| Vol #:
|
| 27
|
| |
|
|
| C 531
|
| M. Badanek
|
| Vol #:
|
| 27
|
| |
|
|
| C 532
|
| S. Fischer
|
| Vol #:
|
| 27
|
| |
|
|
| C 533
|
| J. Plumb
|
| Vol #:
|
| 27
|
| |
|
|
| C 534
|
| Protect All Children's environment
|
| Vol #:
|
| 27
|
| |
|
|
| C 535
|
| L. Campbell
|
| Vol #:
|
| 27
|
| |
|
|
| C 536
|
| J. Delgado
|
| Vol #:
|
| 27
|
| |
|
|
| C 537
|
| DAMS, Intl
|
| Vol #:
|
| 27
|
| |
|
|
| C 538
|
| M. Frere
|
| Vol #:
|
| 27
|
| |
|
|
| C 539
|
| S. Brown, RN
|
| Vol #:
|
| 27
|
| |
|
|
| C 540
|
| W. Logbeck
|
| Vol #:
|
| 27
|
| |
|
|
| C 541
|
| DAMS, Intl
|
| Vol #:
|
| 27
|
| |
|
|
| C 542
|
| N. Coveney
|
| Vol #:
|
| 27
|
| |
|
|
| C 543
|
| T. Moore
|
| Vol #:
|
| 27
|
| |
|
|
| C 544
|
| R. Lindsay
|
| Vol #:
|
| 27
|
| |
|
|
| C 545
|
| DAMS, Intl
|
| Vol #:
|
| 27
|
| |
|
|
| C 546
|
| A. Fish
|
| Vol #:
|
| 27
|
| |
|
|
| C 547
|
| A. Boyden
|
| Vol #:
|
| 27
|
| |
|
|
| C 548
|
| DAMS, Intl
|
| Vol #:
|
| 27
|
| |
|
|
| C 549
|
| M. Brazell
|
| Vol #:
|
| 27
|
| |
|
|
| C 550
|
| DAMS, Intl
|
| Vol #:
|
| 27
|
| |
|
|
| C 551
|
| S. Osborne
|
| Vol #:
|
| 27
|
| |
|
|
| C 552
|
| A. Badger
|
| Vol #:
|
| 27
|
|
| | | | | | | | |
|
| |
|
| C 553
|
| DAMS, Intl
|
| Vol #:
|
| 27
|
| |
|
|
| C 554
|
| T. Plumb
|
| Vol #:
|
| 27
|
| |
|
|
| C 555
|
| No signature
|
| Vol #:
|
| 27
|
| |
|
|
| C 556
|
| S. BAchman
|
| Vol #:
|
| 27
|
| |
|
|
| C 557
|
| M. Thomas
|
| Vol #:
|
| 27
|
| |
|
|
| C 558
|
| T. Nocera, B.S., M.A.
|
| Vol #:
|
| 27
|
| |
|
|
| C 559
|
| K. Franz
|
| Vol #:
|
| 27
|
| |
|
|
| C 560
|
| W and B Hager
|
| Vol #:
|
| 27
|
| |
|
|
| C 561
|
| L. Pellegrini
|
| Vol #:
|
| 27
|
| |
|
|
| EMC 1145
|
| F. Koss
|
| Vol #:
|
| 24
|
| |
|
|
| EMC 1146
|
| J. Mayes
|
| Vol #:
|
| 24
|
| |
|
|
| EMC 1147
|
| J. Antonetti
|
| Vol #:
|
| 24
|
| |
|
|
| 2006N-0378
|
| Review of Agreements, Guidances, and Practices Specific to Assignment of Combination Products in Compliance with the Medical Device User Fee and Modernization Act of 2002
|
| |
|
|
| C 2
|
| Genentech, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| C 3
|
| Abbott Laboratories (Abbott)
|
| Vol #:
|
| 1
|
| |
|
|
| C 4
|
| Pharmaceutical Research and MAnufacturers of America (PhRMA)
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| Genentech, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0414
|
| Suicidality Data from Adult Antidepressant Trials
|
| |
|
|
| EC 10
|
| Ms. Angela Bischoff
|
| Vol #:
|
| 1
|
| |
|
|
| EC 11
|
| Parents of Sheryl. Deceased
|
| Vol #:
|
| 1
|
| |
|
|
| EC 12
|
| Mr. maclean dale
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0464
|
| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
|
| |
|
|
| APE 1
|
| Piedmont Medical Group
|
| Vol #:
|
| 1
|
| |
|
|
| EC 1
|
| Genzyme Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0393
|
| Health Claim Petition: Barley Betafiber and Coronary Heart Disease
|
| |
|
|
| LET 5
|
| Cargill Incorporated
|
| Vol #:
|
| 4
|
| |
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
| |
|
|
| EC 427
|
| Ms. Anita Fabian
|
| Vol #:
|
| 7
|
| |
|
|
| EC 428
|
| Miss. Sage Gang-Halvorson
|
| Vol #:
|
| 7
|
| |
|
|
| EC 429
|
| Miss. AE White
|
| Vol #:
|
| 7
|
|
| |
|
| 2006P-0415
|
| Petition Seeking Regulation of Cloned Animals
|
| |
|
|
| EMC 7
|
| M. Anthony
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 8
|
| C. Hubbard
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
| |
|
| EMC 9
|
| M. Ebbert
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0477
|
| ANDA for potassium chloride oral solution drug products in strengths of 10% and 5%
|
| |
|
|
| ACK 1
|
| HFA-305 to King & Spalding LLP
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| King & Spalding LLP
|
| Vol #:
|
| 1
|
|
|
