|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Dockets Entered On
10/18/2007
|
|
|
|
|
|
|
|
|
|
|
| Docket
#
|
| Title
|
|
|
|
|
|
|
| 1978N-0038
|
| Sunscreen Drug
Products
|
|
|
|
|
| 1998D-0077
|
| Treatment of
osteoarthritis/drugs, devices and biological pt
|
|
|
|
|
| 2000P-1322
|
| Food Labeling and Allergen
Contamination Control
|
|
|
|
|
| 2006D-0347
|
| Guidance for Industry,
Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate
Index Assays
|
|
|
|
|
| 2006N-0454
|
| Use of Ozone-Depleting
Substances; Removal of Essential-Use Designations
|
|
|
|
|
| 2007D-0201
|
| Guidance for Industry and
Food and Drug Administration Staff; Premarket Notification (510(k))
Submissions for Medical Devices That Include Antimicrobial Agents
|
|
|
|
|
| 2007D-0266
|
| International Conference
on Harmonisation; Draft Guidance on Q10 Pharmaceutical Quality
System
|
|
|
|
|
| 2007D-0290
|
| Guidance for Industry:
Cell Selection Devices for Point of Care Production of Minimally
Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
|
|
|
|
|
| 2007N-0347
|
| Information Technology
Strategic Planning; Public Meeting
|
|
|
|
|
| 2007N-0356
|
| BEHIND THE COUNTER
AVAILABILITY OF CERTAIN DRUGS; Public Meeting
|
|
|
|
|
| 2007N-0382
|
| Ramipril Capsules and
180-day generic drug exclusivity
|
|
|
|
|
| 2007P-0074
|
| Over-the-Counter (OTC)
Cough and Cold Drug Products for Children Under 6 Years of Age
|
|
|
|
|
| 2007P-0085
|
| Adopt Regulations of
General Applicability to all Food Standards that would Permit Deviations
from the Requirements of the Individual Food Standards of Identity
|
|
|
|
|
| 2007P-0363
|
| Prevent false and
misleading labeling and ensure the safe and effacious use of dronibinol
|
|
|
|
|
| 2007P-0402
|
| Take regulatory
enforcement action to protect consumers from adulterated and misbranded
laser hair growth medical devices distributed and/or manufactured by five
companies
|
|
|
|
|
| 2007P-0403
|
| ANDA Suitability for
Levomethadyl Acetate HCI 10mg 20mg and 40mg Tablets
|
|
|
|
|
| 1978N-0038
|
| Sunscreen Drug
Products
|
|
|
|
|
| EC 2460
|
| Mrs. Ginger Munoz
|
| Vol
#:
|
| 162
|
|
|
|
|
| 1998D-0077
|
| Treatment of
osteoarthritis/drugs, devices and biological pt
|
|
|
|
|
| EC 3
|
| Pharm Res
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 4
|
| Boehringer Ingelheim
Pharmaceuticals, Inc.
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 5
|
| Fidia Farmaceutici,
S.p.A.
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 6
|
| AstraZeneca LP
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 7
|
| Novartis Pharmaceuticals
Corporation
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 8
|
| GlaxoSmithKline
|
| Vol
#:
|
| 1
|
|
|
|
|
| 2000P-1322
|
| Food Labeling and
Allergen Contamination Control
|
|
|
|
|
| LET 7
|
| Center for Science in the
Public Inetrest CSPI
|
| Vol
#:
|
| 30
|
|
|
|
|
| 2006D-0347
|
| Guidance for Industry,
Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate
Index Assays
|
|
|
|
|
| EC 129
|
| Scott
|
| Vol
#:
|
| 3
|
|
|
|
|
| EC 130
|
| Genetic Alliance
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 131
|
| Genetic Alliance
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 132
|
| Citizens for Quality
Sickle Cell Care, Inc
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 133
|
| Coalition for 21st Cent
Med
|
| Vol
#:
|
| 1
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| EC 134
|
| Target Discovery, Inc
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 135
|
| Goodwin Procter LLP
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 136
|
| Goodwin Procter LLP
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 137
|
| Pendergast Consulting
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 138
|
| Vision Research Foundation, Sankara
Nethralaya
|
| Vol
#:
|
| 1
|
|
|
|
|
| 2006N-0454
|
| Use of Ozone-Depleting
Substances; Removal of Essential-Use Designations
|
|
|
|
|
| C 4202
|
| L. Summers
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4203
|
| H. Robinson
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4204
|
| Unknown
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4205
|
| S. Winga
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4206
|
| M. J. Vanry
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4207
|
| L. B. Bloom
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4208
|
| J. Zarlengo
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4209
|
| R R. Martinsen
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4210
|
| R. Leichtle
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4211
|
| R. Burke
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4212
|
| N. Fergerson
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4213
|
| P. M. Krider
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4214
|
| P. Marlin
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4215
|
| J. P. Smith
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4216
|
| P. M. Carty
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4217
|
| M. B. Bergeron
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4218
|
| L. Stuve
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4219
|
| Unknown
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4220
|
| L. Gilbert
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4221
|
| R. Rolemann
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4222
|
| W. E. Sailer
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4223
|
| S. W. Smalls
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4224
|
| G. Crowley
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4225
|
| S. M. Conta
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4226
|
| F. Tribuno
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4227
|
| K. D. Tucker
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4228
|
| F. Hardy
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4229
|
| W. Camp
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4230
|
| C. Tyler
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4231
|
| Z. Dever
|
| Vol
#:
|
| 40
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| C 4232
|
| L. Byrne
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4233
|
| E. Glemer
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4234
|
| I. Drake
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4235
|
| L. Parker
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4236
|
| S. Vanderier
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4237
|
| P. B. Lynch
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4238
|
| S. Harkin
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4239
|
| Unknown
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4240
|
| Unknown
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4241
|
| K. Bellmey
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4242
|
| A. Evjy
|
| Vol
#:
|
| 40
|
|
|
|
|
| C 4243
|
| C. Himes
|
| Vol
#:
|
| 40
|
|
|
|
|
| 2007D-0201
|
| Guidance for Industry
and Food and Drug Administration Staff; Premarket Notification (510(k))
Submissions for Medical Devices That Include Antimicrobial
Agents
|
|
|
|
|
| EC 6
|
| Center for Biofilm Engineering,
Montana St. Univ.
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 7
|
| Cook Group
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 8
|
| Milliken
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 9
|
| Covidien
|
| Vol
#:
|
| 1
|
|
|
|
|
| 2007D-0266
|
| International
Conference on Harmonisation; Draft Guidance on Q10 Pharmaceutical Quality
System
|
|
|
|
|
| C 3
|
| Japan Society of Pharmaceutical
Machinery and Engineering
|
| Vol
#:
|
| 1
|
|
|
|
|
| 2007D-0290
|
| Guidance for Industry:
Cell Selection Devices for Point of Care Production of Minimally
Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
|
|
|
|
|
| EC 2
|
| Duke University Medical
Center
|
| Vol
#:
|
| 1
|
|
|
|
|
| 2007N-0347
|
| Information Technology
Strategic Planning; Public Meeting
|
|
|
|
|
| EC 12
|
| Mr. William Holt Jowell
|
| Vol
#:
|
| 1
|
|
|
|
|
| 2007N-0356
|
| BEHIND THE COUNTER
AVAILABILITY OF CERTAIN DRUGS; Public Meeting
|
|
|
|
|
| EAPE 108
|
| O'Rangers, Eleanor
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 109
|
| Noble, Ben
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 110
|
| White, Deborah
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 111
|
| Plank, Mary
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 112
|
| Powell, Patricia
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 113
|
| Moore, Kirsten
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 114
|
| Rogers, Jenn
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 115
|
| Illingworth, Betsy
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 116
|
| Tarallo, Kathryn
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 117
|
| Ambizas, Emily
|
| Vol
#:
|
| 1
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| EAPE 118
|
| Bough, Marcie
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 119
|
| Lunner, Kristina
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 120
|
| Appleby, James
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 121
|
| Suydam, Linda
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 122
|
| Spangler, David
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 123
|
| Fish, Andrew
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 124
|
| Schneider, Heinz
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 125
|
| Funderburk, Elizabeth
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 126
|
| Cox, Virginia
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 127
|
| Jones, Mike
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 128
|
| Cetnarowski, Wes
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 129
|
| Razor, Jennifer
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 130
|
| Phan, Stacie
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 131
|
| Khani, Julie
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 132
|
| Shah, Jatin
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 133
|
| Smith Drug Company
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 134
|
| Dutch Dobish, Consultant
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 135
|
| NACDS
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 136
|
| Public Citizen Research Group
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 137
|
| Stiefel Laboratories
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 138
|
| Johnson and Johnson
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 139
|
| KGM Innovation Associates,
Inc.
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 140
|
| Express Scripts Inc.
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 141
|
| 3D Communications
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 142
|
| St. John's University
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 143
|
| Kaye Scholer LLP
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 144
|
| American Society of Health-System
Pharmacists
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 145
|
| Novartis Consumer Healthcare
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 146
|
| Independent Consultant
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 147
|
| McNeil Consumer Healthcare
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 148
|
| CDER
|
| Vol
#:
|
| 1
|
|
|
|
|
| EAPE 149
|
| Granules USA Inc.
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 16
|
| Bell's Drug Store
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 17
|
| Dr. Norman Pillsbury
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 18
|
| Dr. Scott Stamper
|
| Vol
#:
|
| 1
|
|
|
|
|
| 2007N-0382
|
| Ramipril Capsules and
180-day generic drug exclusivity
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| LET 4
|
| Sandoz, Inc.
|
| Vol
#:
|
| 1
|
|
|
|
|
| 2007P-0074
|
| Over-the-Counter (OTC)
Cough and Cold Drug Products for Children Under 6 Years of Age
|
|
|
|
|
| EC 9
|
| Logan View Pediatrics
|
| Vol
#:
|
| 1
|
|
|
|
|
| EC 10
|
| Wyeth Consumer Healthcare
|
| Vol
#:
|
| 1
|
|
|
|
|
| 2007P-0085
|
| Adopt Regulations of
General Applicability to all Food Standards that would Permit Deviations
from the Requirements of the Individual Food Standards of
Identity
|
|
|
|
|
| C 322
|
| J. Meadows
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 323
|
| B. Meadows
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 324
|
| Pascal French Oven
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 325
|
| M. Ollnick
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 326
|
| S. Dablberg
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 327
|
| M. Bredlaum
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 328
|
| J. Shank
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 329
|
| C. Rivera-Hess
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 330
|
| S. Goodman
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 331
|
| C. T. Noonan
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 332
|
| K. Cochran
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 333
|
| Dr. J. L. Steward
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 334
|
| B. Wert
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 335
|
| S. Raichlen
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 336
|
| Harman Chiropractic Center
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 337
|
| G. Reed
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 338
|
| Unknown
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 339
|
| J. Riha
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 340
|
| G. Mavrik
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 341
|
| I. A. White
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 342
|
| Disneyland
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 343
|
| C. Feierabend
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 344
|
| C. Rivera-Hess
|
| Vol
#:
|
| 6
|
|
|
|
|
| C 345
|
| j. B. Bergen
|
| Vol
#:
|
| 6
|
|
|
|
|
| EMC 176
|
| No Signature
|
| Vol
#:
|
| 4
|
|
|
|
|
| EMC 177
|
| No Signature
|
| Vol
#:
|
| 4
|
|
|
|
|
| EMC 178
|
| D.K. Bowman
|
| Vol
#:
|
| 4
|
|
|
|
|
| 2007P-0363
|
| Prevent false and
misleading labeling and ensure the safe and effacious use of dronibinol
|
|
|
|
|
| LET 1
|
| FDA/DDM to Solvay Pharmaceuticals,
Inc.
|
| Vol
#:
|
| 1
|
|
|
|
|
| 2007P-0402
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Take regulatory
enforcement action to protect consumers from adulterated and misbranded
laser hair growth medical devices distributed and/or manufactured by five
companies
|
|
|
|
|
| ACK 1
|
| FDA/DDM to Fuerst, Humphrey,
Ittleman, PL
|
| Vol
#:
|
| 1
|
|
|
|
|
| CP 1
|
| Fuerst, Humphrey, Ittleman,
PL
|
| Vol
#:
|
| 1
|
|
|
|
|
| 2007P-0403
|
| ANDA Suitability for
Levomethadyl Acetate HCI 10mg 20mg and 40mg Tablets
|
|
|
|
|
| ACK 1
|
| FDA/ DDM/ to VCU School of
Medicine
|
| Vol
#:
|
| 1
|
|
|
|
|
| CP 1
|
| VCU School of Medicine
|
| Vol
#:
|
| 1
| |
|
