| | | | | | | | | | |
|
|
| Dockets Entered
On October 18, 2006
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1997D-0318
|
| Revised Precautionary Measure to Reduce Transmission of CJD
|
|
|
| 2001E-0213
|
| Angiomax, Patent Term Extension Application, No. 5,196,404
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
| 2003E-0146
|
| Patent Extension Application for RELPAX, No. 5,545,644
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| 2004D-0228
|
| Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV'
|
|
|
| 2004E-0039
|
| Patent Extension for CRESTOR (rosuvastatin), U.S. Patent No. RE37,314
|
|
|
| 2005E-0235
|
| Patent Extension Application for VESIcare (solifenacin succinate), U.S. Patent No. 6,017,927
|
|
|
| 2005E-0238
|
| Patent Extension Application for TYSABRI (natalizumab), U.S. Patent No. 5,840,299
|
|
|
| 2005E-0239
|
| Patent Extension Application for PRIALT (ziconotide), U.S. Patent No. 5,364,842
|
|
|
| 2005E-0246
|
| Patent Extension Appliation for PRIALT (ziconotide), U.S. Patent No. 5,795,864
|
|
|
| 2005E-0256
|
| Patent Extension Application for Ovidrel (choriogonadotropin alfa (recombinant human chorionic gonadotripin (r-HCG)), U.S. Patent No. 4,840,896
|
|
|
| 2005P-0402
|
| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic-depressive illness."
|
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| 2006D-0331
|
| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
|
|
|
| 2006D-0336
|
| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
| 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
|
|
|
| 2006M-0343
|
| P050010 - PRODISC-L Total Disc Replacement
|
|
|
| 2006N-0107
|
| FDA-Regulated Products Containing Nanotechnology Materials
|
|
|
| 2006N-0219
|
| Clinical Trial Design Issues in the Development of Products for Treatment of Chronic Hepatitis C Infection
|
|
|
| 2006N-0352
|
| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
|
|
|
| 2006P-0124
|
| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
|
|
|
| 2006P-0158
|
| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
|
|
|
| 2006P-0361
|
| Deny Request to switch ketotifen fumarate ophthalmic solution, 0.025%
|
|
|
| 2006P-0387
|
| Declare That Clobetasol Propionate from, 0.05% is suitable for submission in an ANDA.
|
|
|
| 2006P-0390
|
| Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
| 2006P-0403
|
| Determine whether an Abbreviated New Drug Application can be filed against the listed drug Novamine 15%, manufactured by Hospira under NDA 17-957
|
|
|
| 1997D-0318
|
| Revised Precautionary Measure to Reduce Transmission of CJD
|
|
|
| C 38
|
| University of Iowa Hospitals and Clinics
|
| Vol #:
|
| 4
|
|
|
| EC 14
|
| AABB
|
| Vol #:
|
| 4
|
|
|
| 2001E-0213
|
| Angiomax, Patent Term Extension Application, No. 5,196,404
|
|
| | | | | | | | |
|
|
| ACK 1
|
| FDA/DDM to Generamedix Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
| CP 1
|
| Generamedix Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
| C 2097
|
| Form Letters
|
| Vol #:
|
| 350
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
| EMC 718
|
| R. Ulrich
|
| Vol #:
|
| 10
|
|
|
| EMC 719
|
| Mission Possible International
|
| Vol #:
|
| 10
|
|
|
| EMC 720
|
| Mission Possible International
|
| Vol #:
|
| 10
|
|
|
| EMC 721
|
| Mission Possible International
|
| Vol #:
|
| 10
|
|
|
| EMC 722
|
| Mission Possible International
|
| Vol #:
|
| 10
|
|
|
| EMC 723
|
| Mission Possible International
|
| Vol #:
|
| 10
|
|
|
| EMC 724
|
| Mission Possible International
|
| Vol #:
|
| 10
|
|
|
| EMC 725
|
| Calorie Control Council
|
| Vol #:
|
| 10
|
|
|
| 2003E-0146
|
| Patent Extension Application for RELPAX, No. 5,545,644
|
|
|
| LET 5
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| EMC 1359
|
| K. Carlson
|
| Vol #:
|
| 12
|
|
|
| EMC 1360
|
| M. Elmer
|
| Vol #:
|
| 12
|
|
|
| 2004D-0228
|
| Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV'
|
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
| NAD 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004E-0039
|
| Patent Extension for CRESTOR (rosuvastatin), U.S. Patent No. RE37,314
|
|
|
| LET 5
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2005E-0235
|
| Patent Extension Application for VESIcare (solifenacin succinate), U.S. Patent No. 6,017,927
|
|
|
| LET 5
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2005E-0238
|
| Patent Extension Application for TYSABRI (natalizumab), U.S. Patent No. 5,840,299
|
|
|
| LET 6
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2005E-0239
|
| Patent Extension Application for PRIALT (ziconotide), U.S. Patent No. 5,364,842
|
|
|
| LET 6
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2005E-0246
|
| Patent Extension Appliation for PRIALT (ziconotide), U.S. Patent No. 5,795,864
|
|
|
| LET 6
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| 2005E-0256
|
| Patent Extension Application for Ovidrel (choriogonadotropin alfa (recombinant human chorionic gonadotripin (r-HCG)), U.S. Patent No. 4,840,896
|
|
|
| LET 6
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2005P-0402
|
| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic- depressive illness."
|
|
|
|
|
|
| C 4
|
| National Alliance on Mental Illness (NAMI)
|
| Vol #:
|
| 5
|
|
|
| LET 2
|
| FDA/CDER to National Alliance on Mental Illness (NAMI)
|
| Vol #:
|
| 5
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| EMC 4008
|
| B. Peeler
|
| Vol #:
|
| 195
|
|
|
| EMC 4009
|
| B. Peeler
|
| Vol #:
|
| 195
|
|
|
| EMC 4010
|
| C. Robertson
|
| Vol #:
|
| 195
|
|
|
| EMC 4011
|
| S. Turnblom
|
| Vol #:
|
| 195
|
|
|
| EMC 4012
|
| D. Field
|
| Vol #:
|
| 195
|
|
|
| EMC 4013
|
| R. Beaulieu
|
| Vol #:
|
| 195
|
|
|
| EMC 4014
|
| M. Lenker
|
| Vol #:
|
| 195
|
|
|
| EMC 4015
|
| C. Dougherty
|
| Vol #:
|
| 195
|
|
|
| EMC 4016
|
| R. Sammarco
|
| Vol #:
|
| 195
|
|
|
| 2006D-0331
|
| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
|
|
| EC 38
|
| Methodist Healthcare
|
| Vol #:
|
| 2
|
|
|
| EC 39
|
| Mr. Sean Davis
|
| Vol #:
|
| 2
|
|
|
| EC 40
|
| Dr. Richard Levine
|
| Vol #:
|
| 2
|
|
|
| EC 41
|
| Dr. E Brooke Lerner
|
| Vol #:
|
| 2
|
|
|
| 2006D-0336
|
| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
|
|
|
| EC 4
|
| Mr. Kevin McNamara
|
| Vol #:
|
| 1
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
| EC 5
|
| GHC Technologies, Inc.
|
| Vol #:
|
| 1
|
|
|
| 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
|
|
|
|
|
|
| EC 2
|
| Mr. Walter Weber
|
| Vol #:
|
| 1
|
|
|
| 2006M-0343
|
| P050010 - PRODISC-L Total Disc Replacement
|
|
|
| CR 1
|
| Synthes Spine Co., L. P.
|
| Vol #:
|
| 1
|
|
|
| 2006N-0107
|
| FDA-Regulated Products Containing Nanotechnology Materials
|
|
|
| EC 18
|
| finding1cure@yahoogroups.com
|
| Vol #:
|
| 12
|
|
| | | | | | | | |
|
|
| EC 19
|
| Mr. Paul Tuff
|
| Vol #:
|
| 12
|
|
|
| EC 20
|
| Mrs. COLIN Mathilde
|
| Vol #:
|
| 12
|
|
|
| 2006N-0219
|
| Clinical Trial Design Issues in the Development of Products for Treatment of Chronic Hepatitis C Infection
|
|
|
| EC 4
|
| Mr. Philip Anthony
|
| Vol #:
|
| 1
|
|
|
| 2006N-0352
|
| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
|
|
|
| EC 71
|
| Dental Care
|
| Vol #:
|
| 13
|
|
|
| EC 72
|
| Dental Care
|
| Vol #:
|
| 3
|
|
|
| EC 73
|
| Dental Care
|
| Vol #:
|
| 3
|
|
|
| EC 74
|
| Dental Care
|
| Vol #:
|
| 3
|
|
|
| EC 75
|
| Dental Care
|
| Vol #:
|
| 3
|
|
|
| EC 76
|
| Mom
|
| Vol #:
|
| 3
|
|
|
| EC 77
|
| Pediatric Physical Therapist
|
| Vol #:
|
| 3
|
|
|
| EC 78
|
| The Centre for Dentistry
|
| Vol #:
|
| 3
|
|
|
| EC 79
|
| Dennis L Anderson DDS
|
| Vol #:
|
| 3
|
|
|
| EC 80
|
| Dental Care
|
| Vol #:
|
| 3
|
|
|
| EC 81
|
| Dental Care
|
| Vol #:
|
| 3
|
|
|
| EC 82
|
| Mrs. LENOA WILLIAMSON
|
| Vol #:
|
| 3
|
|
|
| EMC 397
|
| J. Wilson, Jr., M.D., FAAFP, FAAEM, DIBEM, DABNT, DABCMT
|
| Vol #:
|
| 6
|
|
|
| EMC 398
|
| J. Blanco
|
| Vol #:
|
| 6
|
|
|
| EMC 399
|
| F. Levy
|
| Vol #:
|
| 6
|
|
|
| EMC 400
|
| S. Rogers
|
| Vol #:
|
| 6
|
|
|
| 2006P-0124
|
| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
|
|
|
| C 3
|
| D. Lowe
|
| Vol #:
|
| 1
|
|
|
| 2006P-0158
|
| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
|
|
|
| EMC 37
|
| Form Letters
|
| Vol #:
|
| 3
|
|
|
| EMC 38
|
| E. Arellano
|
| Vol #:
|
| 1
|
|
|
| EMC 39
|
| K. Boone
|
| Vol #:
|
| 1
|
|
|
| EMC 40
|
| J. Gunn
|
| Vol #:
|
| 1
|
|
|
| EMC 41
|
| S. Outlaw
|
| Vol #:
|
| 1
|
|
|
| EMC 42
|
| K. Pearsall
|
| Vol #:
|
| 1
|
|
|
| EMC 43
|
| J. Jenainati
|
| Vol #:
|
| 1
|
|
|
| EMC 44
|
| M. LaBerge
|
| Vol #:
|
| 1
|
|
|
| EMC 45
|
| D. Stone
|
| Vol #:
|
| 1
|
|
|
| EMC 46
|
| D. Livengood
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| EMC 47
|
| Carole W.
|
| Vol #:
|
| 1
|
|
|
| EMC 48
|
| P. Morris
|
| Vol #:
|
| 1
|
|
|
| EMC 49
|
| J. Frazier
|
| Vol #:
|
| 1
|
|
|
| EMC 50
|
| S. Weyand
|
| Vol #:
|
| 1
|
|
|
| EMC 51
|
| J. Coccia
|
| Vol #:
|
| 1
|
|
|
| EMC 52
|
| E. Barron
|
| Vol #:
|
| 1
|
|
|
| EMC 53
|
| J. Zenos
|
| Vol #:
|
| 1
|
|
|
| EMC 54
|
| J. Wang
|
| Vol #:
|
| 1
|
|
|
| EMC 55
|
| D. Russell
|
| Vol #:
|
| 1
|
|
|
| EMC 56
|
| R. Newman
|
| Vol #:
|
| 1
|
|
|
| EMC 57
|
| K. Croteau
|
| Vol #:
|
| 1
|
|
|
| EMC 58
|
| C. Meyer
|
| Vol #:
|
| 1
|
|
|
| EMC 59
|
| J. Rossi
|
| Vol #:
|
| 1
|
|
|
| EMC 60
|
| K. Foote
|
| Vol #:
|
| 1
|
|
|
| EMC 61
|
| K. Russell
|
| Vol #:
|
| 1
|
|
|
| EMC 62
|
| A. Sheldon
|
| Vol #:
|
| 1
|
|
|
| EMC 63
|
| A. Swalve
|
| Vol #:
|
| 1
|
|
|
| EMC 64
|
| K. Houston
|
| Vol #:
|
| 1
|
|
|
| EMC 65
|
| L. Clifford
|
| Vol #:
|
| 1
|
|
|
| EMC 66
|
| R. Ulrich
|
| Vol #:
|
| 1
|
|
|
| EMC 67
|
| A. Stature
|
| Vol #:
|
| 1
|
|
|
| 2006P-0361
|
| Deny Request to switch ketotifen fumarate ophthalmic solution, 0.025%
|
|
|
| C 1
|
| Novartis Ophthalmics
|
| Vol #:
|
| 1
|
|
|
| 2006P-0387
|
| Declare That Clobetasol Propionate from, 0.05% is suitable for submission in an ANDA.
|
|
|
| EC 1
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
|
|
| 2006P-0390
|
| Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
|
|
|
| EC 4
|
| Mr. Jerry Staton
|
| Vol #:
|
| 1
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
| C 6
|
| M. Rosenberg
|
| Vol #:
|
| 1
|
|
|
| C 7
|
| R. Claypool
|
| Vol #:
|
| 1
|
|
|
| C 8
|
| M. Bean
|
| Vol #:
|
| 1
|
|
|
| EC 68
|
| Baltimore Green Party
|
| Vol #:
|
| 2
|
|
|
| EC 69
|
| Ms. Dianne Marlow
|
| Vol #:
|
| 2
|
|
|
| EC 70
|
| MFA
|
| Vol #:
|
| 2
|
|
| | | | | | | |
|
|
| EC 71
|
| Ms. stephanie rubin
|
| Vol #:
|
| 2
|
|
|
| EC 72
|
| Mrs. Jennifer Christensen
|
| Vol #:
|
| 2
|
|
|
| EC 73
|
| Ms. Melissa Koslowsky
|
| Vol #:
|
| 2
|
|
|
| EC 74
|
| Mr. mike morf
|
| Vol #:
|
| 2
|
|
|
| EC 75
|
| Miss. Megan Brosh
|
| Vol #:
|
| 2
|
|
|
| EC 76
|
| Ms. R. Gindin-Clarke
|
| Vol #:
|
| 2
|
|
|
| EC 77
|
| University of Rochester
|
| Vol #:
|
| 2
|
|
|
| EC 78
|
| Miss. Shalini Wickramatilake
|
| Vol #:
|
| 2
|
|
|
| EC 79
|
| Miss. Amy Johnson
|
| Vol #:
|
| 2
|
|
|
| EC 80
|
| Miss. Jennifer Leighton
|
| Vol #:
|
| 2
|
|
|
| EC 81
|
| Miss. Emily Zaner
|
| Vol #:
|
| 2
|
|
|
| EC 82
|
| Ms. Jennifer DeLorge McKeown
|
| Vol #:
|
| 2
|
|
|
| EC 83
|
| Mr. Benjamin Davidow
|
| Vol #:
|
| 2
|
|
|
| EC 84
|
| Mr. David Betts
|
| Vol #:
|
| 2
|
|
|
| EC 85
|
| Ms. Louise McGauley
|
| Vol #:
|
| 2
|
|
|
| EC 86
|
| Dr. Chris Cobb
|
| Vol #:
|
| 2
|
|
|
| EC 87
|
| Mr. Joshua Anders
|
| Vol #:
|
| 2
|
|
|
| EC 88
|
| Ms. Jillian Marr
|
| Vol #:
|
| 2
|
|
|
| EC 89
|
| Ms. L Parker
|
| Vol #:
|
| 2
|
|
|
| EC 90
|
| Mr. Mike Pendleton
|
| Vol #:
|
| 2
|
|
|
| EC 91
|
| Mrs. Deborah Gray
|
| Vol #:
|
| 2
|
|
|
| EC 92
|
| NRV-CARE, TREE
|
| Vol #:
|
| 2
|
|
|
| EC 93
|
| Ms. Heather Muchow
|
| Vol #:
|
| 2
|
|
|
| EC 94
|
| Ms. CA Brooks
|
| Vol #:
|
| 2
|
|
|
| EC 95
|
| Miss. Dawn Yukus
|
| Vol #:
|
| 2
|
|
|
| EC 96
|
| Miss. alexa millinger
|
| Vol #:
|
| 2
|
|
|
| EC 97
|
| Ms. Stacey Ziegenhein
|
| Vol #:
|
| 2
|
|
|
| EC 98
|
| individual
|
| Vol #:
|
| 2
|
|
|
| EC 99
|
| Compassion over Killing
|
| Vol #:
|
| 2
|
|
|
| EC 100
|
| Mr. Andrew Spagnolo
|
| Vol #:
|
| 2
|
|
|
| EC 101
|
| Ms. Sara Vandepeute
|
| Vol #:
|
| 2
|
|
|
| EC 102
|
| Mr. Josef Reiter
|
| Vol #:
|
| 2
|
|
|
| EC 103
|
| Mr. Robert Gregory
|
| Vol #:
|
| 2
|
|
|
| EC 104
|
| Ms. Karolina Dembinska-Lemus
|
| Vol #:
|
| 2
|
|
|
| EC 105
|
| Mocha Moms
|
| Vol #:
|
| 2
|
|
|
| EC 106
|
| Mrs. Heidi Gysan
|
| Vol #:
|
| 2
|
|
|
| EC 107
|
| Ms. Kerrie Kibling
|
| Vol #:
|
| 2
|
|
| | | | | | | |
|
|
| EC 108
|
| Ms. Rachel Thompson
|
| Vol #:
|
| 2
|
|
|
| EC 109
|
| Ms. Erika Lloyd
|
| Vol #:
|
| 2
|
|
|
| EC 110
|
| Miss. Heidi Chan
|
| Vol #:
|
| 2
|
|
|
| EC 111
|
| Miss. MAGDA bOROWICZ
|
| Vol #:
|
| 2
|
|
|
| EC 112
|
| Mr. Colin McDaniel
|
| Vol #:
|
| 2
|
|
|
| EC 113
|
| Ms. Erica Tokar
|
| Vol #:
|
| 2
|
|
|
| EC 114
|
| Ms. Monique Fordham
|
| Vol #:
|
| 2
|
|
|
| EC 115
|
| Dr. Aubrey Hanbicki
|
| Vol #:
|
| 2
|
|
|
| EC 116
|
| Mr. Matthew OLeary
|
| Vol #:
|
| 2
|
|
|
| EC 117
|
| Miss. Sara Ziegelbaum
|
| Vol #:
|
| 2
|
|
|
| EC 118
|
| Mr. Christopher Maiuri
|
| Vol #:
|
| 2
|
|
|
| EC 119
|
| Mr. howard kallem
|
| Vol #:
|
| 2
|
|
|
| EC 120
|
| Mr. Alex Amato
|
| Vol #:
|
| 2
|
|
|
| EC 121
|
| Mr. Praveen Mantena
|
| Vol #:
|
| 2
|
|
|
| EC 122
|
| Mr. Christopher Maurer
|
| Vol #:
|
| 2
|
|
|
| EC 123
|
| Ms. shana jahn
|
| Vol #:
|
| 2
|
|
|
| EC 124
|
| Mr. James Boutin
|
| Vol #:
|
| 2
|
|
|
| EC 125
|
| Mr. Dave Colburn
|
| Vol #:
|
| 2
|
|
|
| EC 126
|
| Mr. Justin Fertig
|
| Vol #:
|
| 2
|
|
|
| EC 127
|
| Ms. Marcia Harrington
|
| Vol #:
|
| 2
|
|
|
| EC 128
|
| Ms. Donna Jones
|
| Vol #:
|
| 2
|
|
|
| EC 129
|
| Ms. Susan THomas
|
| Vol #:
|
| 2
|
|
|
| EC 130
|
| Mr. Christopher Thomas
|
| Vol #:
|
| 2
|
|
|
| EC 131
|
| Ancient Soul Healing
|
| Vol #:
|
| 2
|
|
|
| EC 132
|
| AVMA
|
| Vol #:
|
| 2
|
|
|
| EC 133
|
| Mr. Jorge Mera
|
| Vol #:
|
| 2
|
|
|
| EC 134
|
| Animal Liberation League
|
| Vol #:
|
| 2
|
|
|
| EC 135
|
| Miss. Gabriele Johnson
|
| Vol #:
|
| 2
|
|
|
| EC 136
|
| Ms. Amanda Carlozzi
|
| Vol #:
|
| 2
|
|
|
| EC 137
|
| Ms. Julie Konop
|
| Vol #:
|
| 2
|
|
|
| EC 138
|
| Ms. kathlen bartolomeo
|
| Vol #:
|
| 2
|
|
|
| EC 139
|
| V H Usher MD PC
|
| Vol #:
|
| 2
|
|
|
| EC 140
|
| Miss. Briana Wagner
|
| Vol #:
|
| 2
|
|
|
| EC 141
|
| Ms. Sara Nemati
|
| Vol #:
|
| 2
|
|
|
| EC 142
|
| Miss. Lauren Whiteman
|
| Vol #:
|
| 2
|
|
|
| EC 143
|
| Ms. Lara Wagner
|
| Vol #:
|
| 2
|
|
|
| EC 144
|
| Ms. Christopher Braudy
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
|
| EC 145
|
| Mrs. sonia greene
|
| Vol #:
|
| 2
|
|
|
| EC 146
|
| Ms. Kelly Ernst
|
| Vol #:
|
| 2
|
|
|
| EC 147
|
| Ms. marianne lee
|
| Vol #:
|
| 2
|
|
|
| EC 148
|
| Ms. Ashley Curran
|
| Vol #:
|
| 2
|
|
|
| EC 149
|
| N/A
|
| Vol #:
|
| 2
|
|
|
| EC 150
|
| Ms. Jennifer Granzow
|
| Vol #:
|
| 2
|
|
|
| EC 151
|
| Ms. Margaret MacDonnell
|
| Vol #:
|
| 2
|
|
|
| EC 152
|
| Miss. Stephanie DeMoss
|
| Vol #:
|
| 2
|
|
|
| EC 153
|
| Ms. Shana Sandberg
|
| Vol #:
|
| 2
|
|
|
| EC 154
|
| Ms. Heather Frei
|
| Vol #:
|
| 2
|
|
|
| EC 155
|
| Dr. Barbara Butera
|
| Vol #:
|
| 2
|
|
|
| EC 156
|
| Mr. James McDonough
|
| Vol #:
|
| 2
|
|
|
| EC 157
|
| Miss. Allison Brown
|
| Vol #:
|
| 2
|
|
|
| EC 158
|
| Ms. Iza Milani
|
| Vol #:
|
| 2
|
|
|
| EC 159
|
| Ms. Jeanne Locher
|
| Vol #:
|
| 2
|
|
|
| EC 160
|
| Ms. Carmen Harris
|
| Vol #:
|
| 2
|
|
|
| EC 161
|
| Ms. Michele Wildeboer
|
| Vol #:
|
| 2
|
|
|
| EC 162
|
| Greenpeace USA
|
| Vol #:
|
| 2
|
|
|
| EC 163
|
| Mr. Erick Solberg
|
| Vol #:
|
| 2
|
|
|
| EC 164
|
| Miss. Kirstin Emershaw
|
| Vol #:
|
| 2
|
|
|
| EC 165
|
| Mr. Kenn Chandler
|
| Vol #:
|
| 2
|
|
|
| EC 166
|
| Miss. Jessica Turner
|
| Vol #:
|
| 2
|
|
|
| EC 167
|
| Ms. Gloria Feldscher
|
| Vol #:
|
| 2
|
|
|
| EC 168
|
| Ms. Alexis Martin
|
| Vol #:
|
| 2
|
|
|
| EC 169
|
| Ms. Misti Schmidt
|
| Vol #:
|
| 2
|
|
|
| EC 170
|
| Ms. Nicole Faby
|
| Vol #:
|
| 2
|
|
|
| EC 171
|
| Ms. Rachel Seligman
|
| Vol #:
|
| 2
|
|
|
| EC 172
|
| Mrs. Bonnie Knight
|
| Vol #:
|
| 2
|
|
|
| EC 173
|
| Ms. Amanda Chawansky
|
| Vol #:
|
| 2
|
|
|
| 2006P-0403
|
| Determine whether an Abbreviated New Drug Application can be filed against the listed drug Novamine 15%, manufactured by Hospira under NDA 17-957
|
|
|
| EC 2
|
| Mr. david lowe
|
| Vol #:
|
| 2
|
|
|