| | | | | | | | | | |
| |
|
|
| Dockets Entered
On September 28, 2007
|
|
|
|
|
|
|
| |
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1978N-0038
|
| Sunscreen Drug Products
|
| |
|
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| 1998D-0307
|
| Exports/Imports under FDA export reform/enhancement Act 1996
|
| |
|
|
| 2005P-0146
|
| to establish guidance or regulations providing bioequivalence requirement for oral locally-acting gastrointestinal(GI) drug products prior to approval of any generic versions of such drugs
|
| |
|
|
| 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-0249
|
| Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
|
| |
|
|
| 2007N-0321
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
|
|
|
|
|
|
| 2007N-0330
|
| Presidential Interagency Working Group on Import Safety; Public Meeting
|
| |
|
|
| 2007P-0097
|
| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
|
|
|
|
|
|
|
|
|
| 2007P-0130
|
| Seeking Immediate Approval of ANDA No. 78-226 for Amlodipine Besylate
|
| |
|
|
| 2007P-0209
|
| Not to grant final ANDA approval for any generic versions of Toprol-XL, metoprolol succinate extended-release tablets (metoprolol) 50, mg
|
| |
|
|
| 2007P-0282
|
| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
|
| |
|
|
| 2007P-0297
|
| Request to reconsider the failure to approve Provenge
|
| |
|
|
| 2007P-0320
|
| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
|
| |
|
|
| 2007P-0333
|
| Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa
|
|
|
|
|
|
|
|
|
| 2007P-0363
|
| Prevent false and misleading labeling and ensure the safe and effacious use of dronibinol
|
|
| |
|
| 1978N-0038
|
| Sunscreen Drug Products
|
| |
|
|
| EC 2445
|
| Dr. Angela Gilley
|
| Vol #:
|
| 161
|
| |
|
|
| EC 2446
|
| Mrs. Felicia Czumble
|
| Vol #:
|
| 161
|
| |
|
|
| EC 2447
|
| Ms. T Amar
|
| Vol #:
|
| 161
|
| |
|
|
| EC 2448
|
| Miss. Minova Earle
|
| Vol #:
|
| 161
|
| |
|
|
| EC 2449
|
| D. Miller
|
| Vol #:
|
| 161
|
| |
|
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
| |
|
|
| RPT 25
|
| ROC
|
| Vol #:
|
| 1
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET 20877
|
| Enzymatic
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20878
|
| Enzymatic
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20879
|
| Enzymatic
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20880
|
| Enzymatic
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20881
|
| Enzymatic
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20882
|
| Natural Organics, Inc.
|
| Vol #:
|
| 181
|
|
| | | | | | | | |
|
| |
|
| LET 20883
|
| Natural Organics, Inc.
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20884
|
| Natural Organics, Inc.
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20885
|
| Natural Organics, Inc.
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20886
|
| Natural Organics, Inc.
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20887
|
| Natural Organics, Inc.
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20888
|
| Natural Organics, Inc.
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20889
|
| Natural Organics, Inc.
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20890
|
| Natural Organics, Inc.
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20891
|
| Natural Organics, Inc.
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20892
|
| Natural Organics, Inc.
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20893
|
| NOW Foods
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20894
|
| NOW Foods
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20895
|
| NOW Foods
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20896
|
| NOW Foods
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20897
|
| Natural Organics, Inc.
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20898
|
| Shaklee
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20899
|
| Enzymatic
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20900
|
| Enzymatic
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20901
|
| Enzymatic
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20902
|
| Enzymatic
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20903
|
| Enzymatic
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20904
|
| Enzymatic
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20905
|
| Enzymatic
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20906
|
| Frutels, LLC
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20907
|
| PT Metrics LLC
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20908
|
| VitaGiant Laboratories, Inc.
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20909
|
| Market America, Inc.
|
| Vol #:
|
| 181
|
| |
|
|
| LET 20910
|
| Market America, Inc.
|
| Vol #:
|
| 181
|
| |
|
|
| 1998D-0307
|
| Exports/Imports under FDA export reform/enhancement Act 1996
|
| |
|
|
| EC 61
|
| Dr. A B
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0146
|
| to establish guidance or regulations providing bioequivalence requirement for oral locally-acting gastrointestinal(GI) drug products prior to approval of any generic versions of such drugs
|
|
|
|
|
|
| | |
|
|
| SUP 4
|
| Salix Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
| |
|
|
| EC 124
|
| Agendia BV
|
| Vol #:
|
| 3
|
|
| | | | | | | | |
|
| |
|
| 2006N-0454
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
|
| |
|
|
| C 3192
|
| S Severson
|
| Vol #:
|
| 30
|
| |
|
|
| C 3193
|
| M Pappenfus
|
| Vol #:
|
| 30
|
| |
|
|
| C 3194
|
| R Flood
|
| Vol #:
|
| 30
|
| |
|
|
| C 3195
|
| A Garner
|
| Vol #:
|
| 30
|
| |
|
|
| C 3196
|
| D Mix
|
| Vol #:
|
| 30
|
| |
|
|
| C 3197
|
| J Stocks
|
| Vol #:
|
| 30
|
| |
|
|
| C 3198
|
| E Hussin
|
| Vol #:
|
| 30
|
| |
|
|
| C 3199
|
| R Hein
|
| Vol #:
|
| 30
|
| |
|
|
| C 3200
|
| R Dunnam
|
| Vol #:
|
| 30
|
| |
|
|
| C 3201
|
| D McGinnis
|
| Vol #:
|
| 30
|
| |
|
|
| C 3202
|
| N Huckabee
|
| Vol #:
|
| 30
|
| |
|
|
| C 3203
|
| K Schexnider
|
| Vol #:
|
| 30
|
| |
|
|
| C 3204
|
| C Baisquet
|
| Vol #:
|
| 30
|
| |
|
|
| C 3205
|
| E Jenerose
|
| Vol #:
|
| 30
|
| |
|
|
| C 3206
|
| V Smith
|
| Vol #:
|
| 30
|
| |
|
|
| C 3207
|
| B Fischer
|
| Vol #:
|
| 30
|
| |
|
|
| C 3208
|
| C Davis
|
| Vol #:
|
| 30
|
| |
|
|
| C 3209
|
| J Buck
|
| Vol #:
|
| 30
|
| |
|
|
| C 3210
|
| A Harris
|
| Vol #:
|
| 30
|
| |
|
|
| C 3211
|
| K Shipman
|
| Vol #:
|
| 30
|
| |
|
|
| C 3212
|
| M Kettler
|
| Vol #:
|
| 30
|
| |
|
|
| C 3213
|
| B Troup
|
| Vol #:
|
| 30
|
| |
|
|
| C 3214
|
| J Tullo
|
| Vol #:
|
| 30
|
| |
|
|
| C 3215
|
| H Daniels Sr
|
| Vol #:
|
| 30
|
| |
|
|
| C 3216
|
| G Burger
|
| Vol #:
|
| 30
|
| |
|
|
| C 3217
|
| H Stienstra
|
| Vol #:
|
| 30
|
| |
|
|
| C 3218
|
| L Harbin
|
| Vol #:
|
| 30
|
| |
|
|
| C 3219
|
| B Rogers
|
| Vol #:
|
| 30
|
| |
|
|
| C 3220
|
| B Barnett
|
| Vol #:
|
| 30
|
| |
|
|
| C 3221
|
| J Riehm
|
| Vol #:
|
| 30
|
| |
|
|
| C 3222
|
| V Wagner
|
| Vol #:
|
| 30
|
| |
|
|
| C 3223
|
| C Bernard
|
| Vol #:
|
| 30
|
| |
|
|
| C 3224
|
| F Hester
|
| Vol #:
|
| 30
|
| |
|
|
| C 3225
|
| C Thompson
|
| Vol #:
|
| 30
|
| |
|
|
| C 3226
|
| P Townsley
|
| Vol #:
|
| 30
|
|
| | | | | | | |
|
| |
|
| C 3227
|
| B Cudo
|
| Vol #:
|
| 30
|
| |
|
|
| C 3228
|
| M Baston
|
| Vol #:
|
| 30
|
| |
|
|
| C 3229
|
| S Morgan
|
| Vol #:
|
| 30
|
| |
|
|
| C 3230
|
| C Rice
|
| Vol #:
|
| 30
|
| |
|
|
| C 3231
|
| B Borisoff
|
| Vol #:
|
| 30
|
| |
|
|
| C 3232
|
| J Welpe
|
| Vol #:
|
| 30
|
| |
|
|
| C 3233
|
| E Jackson
|
| Vol #:
|
| 30
|
| |
|
|
| C 3234
|
| T Kidd
|
| Vol #:
|
| 30
|
| |
|
|
| C 3235
|
| E Lanigan
|
| Vol #:
|
| 30
|
| |
|
|
| C 3236
|
| B Harris
|
| Vol #:
|
| 30
|
| |
|
|
| C 3237
|
| W O'Hara
|
| Vol #:
|
| 30
|
| |
|
|
| C 3238
|
| T Prince
|
| Vol #:
|
| 30
|
| |
|
|
| C 3239
|
| J Ley
|
| Vol #:
|
| 30
|
| |
|
|
| C 3240
|
| J Plake
|
| Vol #:
|
| 30
|
| |
|
|
| C 3241
|
| S Hale
|
| Vol #:
|
| 30
|
| |
|
|
| C 3242
|
| R Orndorff
|
| Vol #:
|
| 30
|
| |
|
|
| C 3243
|
| S Schnidt
|
| Vol #:
|
| 30
|
| |
|
|
| C 3244
|
| D Rabasa
|
| Vol #:
|
| 30
|
| |
|
|
| C 3245
|
| J Juliano
|
| Vol #:
|
| 30
|
| |
|
|
| C 3246
|
| C Anderson
|
| Vol #:
|
| 30
|
| |
|
|
| C 3247
|
| M Gibilterra
|
| Vol #:
|
| 30
|
| |
|
|
| C 3248
|
| B Barwicks
|
| Vol #:
|
| 30
|
| |
|
|
| C 3249
|
| F Del Buono
|
| Vol #:
|
| 30
|
| |
|
|
| C 3250
|
| H Hoge
|
| Vol #:
|
| 30
|
| |
|
|
| C 3251
|
| H Peyregne
|
| Vol #:
|
| 30
|
| |
|
|
| C 3252
|
| M Petty
|
| Vol #:
|
| 30
|
| |
|
|
| C 3253
|
| V Landes
|
| Vol #:
|
| 30
|
| |
|
|
| C 3254
|
| L Cullen
|
| Vol #:
|
| 30
|
| |
|
|
| C 3255
|
| S Schultz
|
| Vol #:
|
| 30
|
| |
|
|
| C 3256
|
| R Dudek
|
| Vol #:
|
| 30
|
| |
|
|
| C 3257
|
| R Phillips
|
| Vol #:
|
| 30
|
| |
|
|
| C 3258
|
| J Baxter
|
| Vol #:
|
| 30
|
| |
|
|
| C 3259
|
| M Osterberg
|
| Vol #:
|
| 30
|
| |
|
|
| C 3260
|
| J Golden
|
| Vol #:
|
| 30
|
| |
|
|
| C 3261
|
| B Critchell
|
| Vol #:
|
| 31
|
| |
|
|
| C 3262
|
| Willson
|
| Vol #:
|
| 31
|
| |
|
|
| C 3263
|
| L Williams
|
| Vol #:
|
| 31
|
|
| | | | | | | |
|
| |
|
| C 3264
|
| R Lynch
|
| Vol #:
|
| 31
|
| |
|
|
| C 3265
|
| H Mendel
|
| Vol #:
|
| 31
|
| |
|
|
| C 3266
|
| N Leggett
|
| Vol #:
|
| 31
|
| |
|
|
| C 3267
|
| J Fales
|
| Vol #:
|
| 31
|
| |
|
|
| C 3268
|
| P Menon
|
| Vol #:
|
| 31
|
| |
|
|
| C 3269
|
| M Colyer
|
| Vol #:
|
| 31
|
| |
|
|
| C 3270
|
| P TatgenHorst
|
| Vol #:
|
| 31
|
| |
|
|
| C 3271
|
| L Ross Jr
|
| Vol #:
|
| 31
|
| |
|
|
| C 3272
|
| G Anderson
|
| Vol #:
|
| 31
|
| |
|
|
| C 3273
|
| H Roske
|
| Vol #:
|
| 31
|
| |
|
|
| C 3274
|
| D Hemmes
|
| Vol #:
|
| 31
|
| |
|
|
| C 3275
|
| D Rienbolt
|
| Vol #:
|
| 31
|
| |
|
|
| C 3276
|
| B Wetters
|
| Vol #:
|
| 31
|
| |
|
|
| C 3277
|
| M Gottlieb
|
| Vol #:
|
| 31
|
| |
|
|
| C 3278
|
| L Cranek
|
| Vol #:
|
| 31
|
| |
|
|
| C 3279
|
| K Galbraith
|
| Vol #:
|
| 31
|
| |
|
|
| C 3280
|
| C Butterfield
|
| Vol #:
|
| 31
|
| |
|
|
| C 3281
|
| J Gibbons
|
| Vol #:
|
| 31
|
| |
|
|
| C 3282
|
| M Burrow
|
| Vol #:
|
| 31
|
| |
|
|
| C 3283
|
| M Goodwin
|
| Vol #:
|
| 31
|
| |
|
|
| C 3284
|
| J Downs
|
| Vol #:
|
| 31
|
| |
|
|
| C 3285
|
| M Micalizzi
|
| Vol #:
|
| 31
|
| |
|
|
| C 3286
|
| G Haynes Sr
|
| Vol #:
|
| 31
|
| |
|
|
| C 3287
|
| B Chain
|
| Vol #:
|
| 31
|
| |
|
|
| C 3288
|
| J Vandelinde
|
| Vol #:
|
| 31
|
| |
|
|
| C 3289
|
| W Persinger
|
| Vol #:
|
| 31
|
| |
|
|
| C 3290
|
| C Ploehn
|
| Vol #:
|
| 31
|
| |
|
|
| C 3291
|
| R Zender
|
| Vol #:
|
| 31
|
| |
|
|
| C 3292
|
| B Wagner
|
| Vol #:
|
| 31
|
| |
|
|
| C 3293
|
| D Burford
|
| Vol #:
|
| 31
|
| |
|
|
| C 3294
|
| M Garrett
|
| Vol #:
|
| 31
|
| |
|
|
| C 3295
|
| J Smith
|
| Vol #:
|
| 31
|
| |
|
|
| C 3296
|
| Dixie Pediatrics
|
| Vol #:
|
| 31
|
| |
|
|
| C 3297
|
| T Adams
|
| Vol #:
|
| 31
|
| |
|
|
| C 3298
|
| C Logan
|
| Vol #:
|
| 31
|
| |
|
|
| C 3299
|
| D Kolander
|
| Vol #:
|
| 31
|
|
| | | | | | | | |
|
| |
|
| 2007D-0249
|
| Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
|
| |
|
|
| C 1
|
| Zimmer
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0321
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
|
|
|
|
|
|
| | |
|
|
| EC 14
|
| State University of New York at Stonybrook
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0330
|
| Presidential Interagency Working Group on Import Safety; Public Meeting
|
| |
|
|
| EC 115
|
| Mrs. Alice Potts
|
| Vol #:
|
| 1
|
| |
|
|
| EC 116
|
| Steel Founders' Society of America
|
| Vol #:
|
| 1
|
| |
|
|
| EC 117
|
| Philadelphia University
|
| Vol #:
|
| 1
|
| |
|
|
| EC 118
|
| COTECNA, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 119
|
| VeritasAnalytics Inc
|
| Vol #:
|
| 1
|
| |
|
|
| EC 120
|
| PakSense Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 121
|
| Consumer Federation of America
|
| Vol #:
|
| 1
|
| |
|
|
| EC 122
|
| Mr. gerald kucera
|
| Vol #:
|
| 1
|
| |
|
|
| EC 123
|
| Mrs. Lenore Swanberg
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0097
|
| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
|
|
|
|
|
|
| | |
|
|
| C 8
|
| James R. Forrester
|
| Vol #:
|
| 1
|
| |
|
|
| C 9
|
| Mitchella Vineyard & Winery
|
| Vol #:
|
| 1
|
| |
|
|
| C 10
|
| Christine Andrus
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0130
|
| Seeking Immediate Approval of ANDA No. 78-226 for Amlodipine Besylate
|
| |
|
|
| WDL 1
|
| Zydus Pharmaceuticals (USA) Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2007P-0209
|
| Not to grant final ANDA approval for any generic versions of Toprol-XL, metoprolol succinate extended-release tablets (metoprolol) 50, mg
|
| |
|
|
| EC 2
|
| KV Pharmaceutical Company
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0282
|
| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
|
| |
|
|
| EC 62
|
| Dr. John Brady
|
| Vol #:
|
| 1
|
| |
|
|
| EC 63
|
| Ms. Barbara Benton St. Gelais
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0297
|
| Request to reconsider the failure to approve Provenge
|
| |
|
|
| EC 102
|
| Mr. Randall Press
|
| Vol #:
|
| 1
|
| |
|
|
| EC 103
|
| Mrs. Bonnie McGrath
|
| Vol #:
|
| 1
|
| |
|
|
| EC 104
|
| Mr. Ernest Swauger
|
| Vol #:
|
| 1
|
| |
|
|
| EC 105
|
| Mr. Steven Pintner
|
| Vol #:
|
| 1
|
| |
|
|
| EC 106
|
| Mr. Mark Allen
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2007P-0320
|
| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
|
| |
|
|
| EC 1
|
| Ms. Aquene Freechild
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| Miss. Genni Chandler
|
| Vol #:
|
| 1
|
| |
|
|
| EC 3
|
| Oregon Center for Environmental Health
|
| Vol #:
|
| 1
|
| |
|
|
| EC 4
|
| Mr. Mike Purvis
|
| Vol #:
|
| 1
|
| |
|
|
| EC 5
|
| Mr. Ralph Markey
|
| Vol #:
|
| 1
|
| |
|
|
| EC 6
|
| Magee-Womens Hospital of UPMC
|
| Vol #:
|
| 1
|
| |
|
|
| EC 7
|
| Ms. Roberta Anderson
|
| Vol #:
|
| 1
|
| |
|
|
| EC 8
|
| Portland State University
|
| Vol #:
|
| 1
|
| |
|
|
| EC 9
|
| Mr. Terry Crossett
|
| Vol #:
|
| 1
|
| |
|
|
| EC 10
|
| Ms. g murphy
|
| Vol #:
|
| 1
|
|
| |
|
| 2007P-0333
|
| Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa
|
|
|
|
|
|
|
| |
|
|
| EC 1
|
| Mr. gerald kucera
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0363
|
| Prevent false and misleading labeling and ensure the safe and effacious use of dronibinol
|
| |
|
|
| ACK 1
|
| FDA/DDM to Unimed Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Unimed Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
