| | | | | | | | | | |
| |
|
|
| Dockets Entered
On February 7, 2007
|
|
|
|
|
|
|
| |
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
| |
|
|
| 2004E-0300
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,800,509
|
| |
|
|
| 2004E-0301
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,891,190
|
| |
|
|
| 2004E-0302
|
| Patent Extenstion for S8 Over-the Wire System ( Driver Stent Delivery System), U.S. Patent No. 6,309,402
|
| |
|
|
| 2004E-0303
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,879,382
|
| |
|
|
| 2004E-0304
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,292,331
|
| |
|
|
| 2004E-0306
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,836,965
|
| |
|
|
| 2004E-0426
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,344,053
|
| |
|
|
| 2004N-0408
|
| Regulatory Site Visit Training Program
|
| |
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| 2006E-0206
|
| Patent Extension Application for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,159,229
|
| |
|
|
| 2006E-0236
|
| Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,494,903
|
| |
|
|
| 2006E-0252
|
| Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
|
| |
|
|
| 2006E-0261
|
| Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
|
| |
|
|
| 2006E-0355
|
| Patent Extension Application for AMITIZA (lubiprostone), U.S. Patent No. 5,284,858
|
| |
|
|
| 2006E-0356
|
| Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
|
| |
|
|
| 2006N-0239
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation
|
| |
|
|
| 2006N-0430
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation an
|
|
|
|
|
|
|
|
|
| 2006N-0464
|
| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
|
| |
|
|
| 2006P-0052
|
| Determine whether Sustiva (efavirenz) Tablets, 300 mg (NDA 21-360), has been voluntarily withdrawn for safety or effectiveness reasons
|
| |
|
|
| 2006P-0069
|
| Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
|
| |
|
|
| 2007D-0025
|
| Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container; Availability
|
| |
|
|
| 2007D-0031
|
| Global Harmonization Task Force, Study Groups 1, 2, and 4; New Proposed and Final Documents; Availability
|
| |
|
|
| 2007N-0016
|
| Sentinel Network To Promote Medical Product Safety
|
| |
|
|
| 2007N-0024
|
| Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing System and Storage Container
|
| |
|
|
| 2007N-0036
|
| Agency Emergency Processing Under Office of Management and Budget Review; Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products; Labeling Comprehension Study
|
|
|
|
|
|
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET 18322
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18323
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18324
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18325
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18326
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
|
| | | | | | | |
|
| |
|
| LET 18327
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18328
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18329
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18330
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18331
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18332
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18333
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18334
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18335
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18336
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18337
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18338
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18339
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18340
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18341
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18342
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18343
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18344
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18345
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18346
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18347
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18348
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18349
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18350
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18351
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18352
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18353
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18354
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18355
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18356
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18357
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18358
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18359
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18360
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18361
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18362
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18363
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
|
| | | | | | | |
|
| |
|
| LET 18364
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18365
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18366
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18367
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18368
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18369
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18370
|
| Natural Organics Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18371
|
| Aminocare Products, L.P.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18372
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18373
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18374
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18375
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18376
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18377
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18378
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18379
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18380
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18381
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18382
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18383
|
| Rokstar International, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18384
|
| Rokstar International, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18385
|
| Rokstar International, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18386
|
| Rokstar International, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18387
|
| Innovative Nurturing Systems Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18388
|
| New Chapter, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18389
|
| New Chapter, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18390
|
| New Chapter, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18391
|
| New Chapter, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18392
|
| New Chapter, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18393
|
| New Chapter, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18394
|
| New Chapter, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18395
|
| American BioSciences Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18396
|
| Natural Organics Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18397
|
| Natural Organics Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18398
|
| NewMark: A Division of New Chapter, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18399
|
| Natural Organics Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18400
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
|
| | | | | | | | |
|
| |
|
| LET 18401
|
| NBTY Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18402
|
| Anabolic Laboratories, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18403
|
| Anabolic Laboratories, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18404
|
| NewMark: A Division of New Chapter, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18405
|
| Metagenics, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
| |
|
|
| C 152
|
| Form Letter count 4
|
| Vol #:
|
| 11
|
| |
|
|
| C 153
|
| D Lowe
|
| Vol #:
|
| 18
|
| |
|
|
| C 154
|
| M Rogers
|
| Vol #:
|
| 18
|
| |
|
|
| C 155
|
| B Williams
|
| Vol #:
|
| 18
|
| |
|
|
| C 156
|
| M Peterson
|
| Vol #:
|
| 18
|
| |
|
|
| C 157
|
| unsigned
|
| Vol #:
|
| 118
|
| |
|
|
| C 158
|
| N Sakellar
|
| Vol #:
|
| 18
|
| |
|
|
| C 159
|
| P Healy
|
| Vol #:
|
| 18
|
| |
|
|
| C 160
|
| J Farrell
|
| Vol #:
|
| 18
|
| |
|
|
| C 161
|
| E Owen
|
| Vol #:
|
| 18
|
| |
|
|
| C 162
|
| M Blackburn
|
| Vol #:
|
| 18
|
| |
|
|
| C 163
|
| A James
|
| Vol #:
|
| 18
|
| |
|
|
| C 164
|
| A Sherman
|
| Vol #:
|
| 18
|
| |
|
|
| C 165
|
| A Steward
|
| Vol #:
|
| 18
|
| |
|
|
| C 166
|
| A Siesenfeld
|
| Vol #:
|
| 18
|
| |
|
|
| C 167
|
| J Mackey
|
| Vol #:
|
| 18
|
| |
|
|
| C 168
|
| J Brewer
|
| Vol #:
|
| 18
|
| |
|
|
| C 169
|
| D Riley
|
| Vol #:
|
| 18
|
| |
|
|
| C 170
|
| M Reed
|
| Vol #:
|
| 18
|
| |
|
|
| C 171
|
| B Lee
|
| Vol #:
|
| 18
|
| |
|
|
| C 172
|
| J Fierstein
|
| Vol #:
|
| 18
|
| |
|
|
| C 173
|
| Wanner Pride-N-Joy Farm
|
| Vol #:
|
| 18
|
| |
|
|
| C 174
|
| L Kolze
|
| Vol #:
|
| 18
|
| |
|
|
| C 175
|
| A Specht
|
| Vol #:
|
| 18
|
| |
|
|
| C 176
|
| E Riddle
|
| Vol #:
|
| 18
|
| |
|
|
| C 177
|
| Joseph & Associates PS
|
| Vol #:
|
| 18
|
| |
|
|
| C 178
|
| E Cohen
|
| Vol #:
|
| 18
|
| |
|
|
| C 179
|
| I Vetsch
|
| Vol #:
|
| 18
|
| |
|
|
| C 180
|
| B Marfil
|
| Vol #:
|
| 18
|
| |
|
|
| C 181
|
| A Bayliss
|
| Vol #:
|
| 18
|
|
| | | | | | | |
|
| |
|
| C 182
|
| K McCabe
|
| Vol #:
|
| 18
|
| |
|
|
| C 183
|
| unsigned
|
| Vol #:
|
| 18
|
| |
|
|
| EC 3401
|
| Mr. Jamie Arbuckle
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3402
|
| taxpayer and voter
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3403
|
| Mrs. lee niesig
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3404
|
| Dr. maria mercedes contreras
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3405
|
| Mrs. Jennifer Schmidt
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3406
|
| Ms. Jan Paley
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3407
|
| Ms. Amber Tidwell
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3408
|
| Mrs. Lori Beth Kidd
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3409
|
| Mrs. Kylie Schwerdtfeger
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3410
|
| Ms. Jambrina Sakellaropoulo
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3411
|
| Miss. Mary ellen Meli
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3412
|
| none
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3413
|
| Ms. Amy Samonds
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3414
|
| Ms. Siobhan Kelly
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3415
|
| Ms. S.M. Keenum
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3416
|
| Ms. ENA SILVA
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3417
|
| Ms. Irene Strauss
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3418
|
| Miss. Lisa LaDore
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3419
|
| Mrs. Diane Barto
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3420
|
| Dr. Jay Gassman
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3421
|
| Ms. Heike Klassmann
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3422
|
| Mrs. Sandra Webster
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3423
|
| Mrs. Linda Gibson
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3424
|
| Miss. Aimee Gintz
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3425
|
| Mrs. Theresa Szpila
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3426
|
| Dr. Renee Snyder
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3427
|
| Mr. James Gilland
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3428
|
| Mrs. Pip Zaat
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3429
|
| Mrs. Shelley Poston
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3430
|
| Mrs. Melinda Shaw
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3431
|
| Ms. Randel Romero
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3432
|
| Ms. Valerie Watson
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3433
|
| Mr. David Paul Xavier Burch
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3434
|
| Ms. Janet Rhodes
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3435
|
| Mr. Derek Stockdale
|
| Vol #:
|
| 21
|
|
| | | | | | | | |
|
| |
|
| EC 3436
|
| Ms. denise russo
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3437
|
| Mr. Antony Mazzotta
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3438
|
| Ms. KERI THOMAS
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3439
|
| Mr. David Kerzner
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3440
|
| Mrs. Clover OBrien
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3441
|
| Ms. Amy Heller
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3442
|
| Miss. Gerry Stearns
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3443
|
| Ms. Andrea Bureman
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3444
|
| Ms. eileen smith
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3445
|
| Mr. Michael Souza
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3446
|
| Ms. Glenda Ross
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3447
|
| Mrs. jadranka juras
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3448
|
| Mr. frank van eeckhout
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3449
|
| Ms. Claire Flewitt
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3450
|
| Mr. Anthony Montapert
|
| Vol #:
|
| 21
|
| |
|
|
| 2004E-0300
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,800,509
|
| |
|
|
| LET 5
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0301
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,891,190
|
| |
|
|
| LET 5
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0302
|
| Patent Extenstion for S8 Over-the Wire System ( Driver Stent Delivery System), U.S. Patent No. 6,309,402
|
| |
|
|
| LET 5
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
| |
|
| 2004E-0303
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,879,382
|
| |
|
|
| LET 5
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0304
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,292,331
|
| |
|
|
| LET 7
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0306
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,836,965
|
| |
|
|
| LET 7
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0426
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,344,053
|
| |
|
|
| LET 5
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0408
|
| Regulatory Site Visit Training Program
|
| |
|
|
| N 3
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
|
| | | | | | | | |
|
| |
|
| EMC 307
|
| K. Shipley
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 308
|
| C. Webster
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 12
|
| L. Hilbert
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 13
|
| Private Citizen
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 14
|
| Celiac Support Group
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 15
|
| J. Gramlich
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 16
|
| Proposed Rules for Gluten Free Labeling
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 17
|
| C. S. A. Celiacs
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 18
|
| J. McCabe
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 19
|
| D. Meier
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 20
|
| R. Woodruff
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 21
|
| N. Daniel
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 22
|
| M. Katz
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 23
|
| D. Green
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 24
|
| C. Allen
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 25
|
| Private Citizen
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 26
|
| K. Day
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 27
|
| M. Healy
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 28
|
| A. Pinkerton
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 29
|
| C. Redrup
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 30
|
| Personal Interest
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 31
|
| S. Rubinstein
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 32
|
| York County Celiac
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 33
|
| M. O'Connell
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 34
|
| T. Weiss
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 35
|
| Health Flavors, Ltd.
|
| Vol #:
|
| 32
|
|
| |
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C 18214
|
| L. Powell
|
| Vol #:
|
| 198
|
| |
|
|
| C 18215
|
| D. Parker
|
| Vol #:
|
| 198
|
| |
|
|
| C 18216
|
| C. Gibson
|
| Vol #:
|
| 198
|
| |
|
|
| C 18217
|
| E. Holober
|
| Vol #:
|
| 198
|
| |
|
|
| C 18218
|
| C. Edwards
|
| Vol #:
|
| 198
|
| |
|
|
| C 18219
|
| D. Tack
|
| Vol #:
|
| 198
|
| |
|
|
| C 18220
|
| Eye Care Center
|
| Vol #:
|
| 198
|
| |
|
|
| C 18221
|
| W. Allar
|
| Vol #:
|
| 198
|
| |
|
|
| C 18222
|
| M. Bartholomeu
|
| Vol #:
|
| 198
|
|
| | | | | | | | |
|
| |
|
| C 18223
|
| A. Allan
|
| Vol #:
|
| 198
|
| |
|
|
| C 18224
|
| C. Powell
|
| Vol #:
|
| 198
|
| |
|
|
| C 18225
|
| A. Krol
|
| Vol #:
|
| 198
|
| |
|
|
| C 18226
|
| H. Harper
|
| Vol #:
|
| 198
|
| |
|
|
| C 18227
|
| S. Salamon
|
| Vol #:
|
| 198
|
| |
|
|
| C 18228
|
| L. Ousley
|
| Vol #:
|
| 198
|
| |
|
|
| C 18229
|
| P. Adams
|
| Vol #:
|
| 198
|
| |
|
|
| C 18230
|
| E. Thorne
|
| Vol #:
|
| 198
|
| |
|
|
| C 18231
|
| A. Stevens
|
| Vol #:
|
| 198
|
| |
|
|
| C 18232
|
| C. Guy
|
| Vol #:
|
| 198
|
| |
|
|
| C 18233
|
| Arkansas Pharmacists Association
|
| Vol #:
|
| 198
|
| |
|
|
| C 18234
|
| D. Landreth
|
| Vol #:
|
| 198
|
| |
|
|
| C 18235
|
| J. Prokesh
|
| Vol #:
|
| 198
|
| |
|
|
| C 18236
|
| P. Jovanov
|
| Vol #:
|
| 198
|
| |
|
|
| C 18237
|
| R. Birckbichler
|
| Vol #:
|
| 198
|
| |
|
|
| C 18238
|
| M. Burns
|
| Vol #:
|
| 198
|
| |
|
|
| C 18239
|
| G. Balentine
|
| Vol #:
|
| 198
|
| |
|
|
| C 18240
|
| M. Lewis
|
| Vol #:
|
| 198
|
|
| |
|
| 2006E-0206
|
| Patent Extension Application for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,159,229
|
| |
|
|
| LET 5
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0236
|
| Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,494,903
|
| |
|
|
| LET 4
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0252
|
| Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
|
| |
|
|
| LET 4
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0261
|
| Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
|
| |
|
|
| LET 4
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0355
|
| Patent Extension Application for AMITIZA (lubiprostone), U.S. Patent No. 5,284,858
|
| |
|
|
| LET 4
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0356
|
| Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
|
| |
|
|
| LET 4
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0239
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation
|
| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| SS 1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0430
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation an
|
|
|
|
|
|
|
| |
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0464
|
| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
|
| |
|
|
| TS 2
|
| TAP Pharmaceutical Products, Inc.
|
| Vol #:
|
| 4
|
| |
|
|
| TS 3
|
| Clinical Ink TM
|
| Vol #:
|
| 4
|
| |
|
|
| TS 4
|
| ThinSpring
|
| Vol #:
|
| 4
|
| |
|
|
| TS 5
|
| CDISC
|
| Vol #:
|
| 4
|
| |
|
|
| TS 6
|
| Surety, LLC
|
| Vol #:
|
| 4
|
| |
|
|
| TS 7
|
| Octagon Research Solutions, Inc.
|
| Vol #:
|
| 4
|
| |
|
|
| TS 8
|
| Alston & Bird LLP
|
| Vol #:
|
| 4
|
| |
|
|
| TS 9
|
| Clinical Research Information Exchange CRIX
|
| Vol #:
|
| 4
|
| |
|
|
| TS 10
|
| Pharmaceutical Research and Manufactureres of America (PhRMA)
|
| Vol #:
|
| 4
|
| |
|
|
| TS 11
|
| JRRapoza Associates, Inc. and Newtech Global Solutions LLC
|
| Vol #:
|
| 4
|
| |
|
|
| TS 12
|
| AGA Medical Corporation
|
| Vol #:
|
| 4
|
| |
|
|
| TS 13
|
| GlobalSubmit, Inc.
|
| Vol #:
|
| 4
|
| |
|
|
| TS 14
|
| Northrop Grumman
|
| Vol #:
|
| 4
|
| |
|
|
| 2006P-0052
|
| Determine whether Sustiva (efavirenz) Tablets, 300 mg (NDA 21-360), has been voluntarily withdrawn for safety or effectiveness reasons
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0069
|
| Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
|
| |
|
|
| NPR 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007D-0025
|
| Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container; Availability
|
| |
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| REF 1
|
| References
|
| Vol #:
|
| 1
|
|
| |
|
| 2007D-0031
|
| Global Harmonization Task Force, Study Groups 1, 2, and 4; New Proposed and Final Documents; Availability
|
| |
|
|
| BKG 1
|
| Background Material
|
| Vol #:
|
| 1
|
| |
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0016
|
| Sentinel Network To Promote Medical Product Safety
|
| |
|
|
| EAPE 104
|
| Rickles, Frederick
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 105
|
| Hassan, Nasser
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 106
|
| Olmstead, Sharon
|
| Vol #:
|
| 1
|
|
| | | | | | | |
|
| |
|
| EAPE 107
|
| Trout, Gretchen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 108
|
| Hollinger, Katherine
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 109
|
| thomas, adrian
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 110
|
| Matthews, William
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 111
|
| Bloch, Carolyn
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 112
|
| Peters, Jenny
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 113
|
| Matthews, Williams
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 114
|
| Matthews, Williams
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 115
|
| Pace, Wilson
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 116
|
| Rothman, John
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 117
|
| Huser, Fred
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 118
|
| Mansbach, Linda
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 119
|
| Hansel, Leighton
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 120
|
| McGlew, John
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 121
|
| Sills, Judith
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 122
|
| Coster, John
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 123
|
| Morris, Kristen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 124
|
| Ludwig, Emily
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 125
|
| Deuster, Tammy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 126
|
| Maher, Michael
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 127
|
| Seltzer, Jonathan
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 128
|
| Bluml, Benjamin
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 129
|
| Ruberg, Stephen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 130
|
| Buchman, Albert
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 131
|
| Stephenson, Hugo
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 132
|
| McShane, Peggy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 133
|
| Marotta, Robert
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 134
|
| Hunter, Joyce
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 135
|
| klincewicz, stephen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 136
|
| White, Alice
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 137
|
| Jenkins-Showalter, Janet
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 138
|
| Goldman, Bette
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 139
|
| Will, Ann
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 140
|
| Stefurak, Steve
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 141
|
| Fortney, Kathleen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 142
|
| Russo, Holly
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 143
|
| Wiley RPH, Angela
|
| Vol #:
|
| 1
|
|
| | | | | | | |
|
| |
|
| EAPE 144
|
| Ringel, Michael
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 145
|
| Mitchell, Kristi
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 146
|
| Woodward, Al
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 147
|
| Pinnow, Ellen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 148
|
| Hoerner, Paul
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 149
|
| Justice, Nilima
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 150
|
| Schubert, Irene
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 151
|
| Melnick, Amy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 152
|
| Waxler, Allison
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 153
|
| Harder, Joel
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 154
|
| Cohen, Donna
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 155
|
| Justice, Nilima
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 156
|
| Harder, Joel
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 157
|
| de Mars, Maryellen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 158
|
| Carey, Carole
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 159
|
| Bohn, Rhonda
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 160
|
| Clement, Jean-Pierre
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 161
|
| Campbell, Cheryl
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 162
|
| Thistlethwaite, Douglas
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 163
|
| Brennan, RPh, Colleen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 164
|
| Kotsanos, James
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 165
|
| Eaton, Richard
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 166
|
| Markowitz, Jay
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 167
|
| Dickinson, Barry
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 168
|
| Long, Rochelle
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 169
|
| Muro, Michael
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 170
|
| Buech, Stephanie
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 171
|
| Wise, Robert
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 172
|
| Tse, Tony
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 173
|
| Pierce, Aaron
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 174
|
| Fennington, Kelly
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 175
|
| Patterson, Amy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 176
|
| Salive, Marcel
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 177
|
| Strickland, Dennis
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 178
|
| Sporn, Douglas
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 179
|
| Cisneros, Robin
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 180
|
| Cisneros, Robin
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EAPE 181
|
| Manion, Douglas
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 182
|
| Jones, Judith
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 183
|
| Platt, Richard
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 184
|
| Cascade, Elisa
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 185
|
| Mansfield, Mari
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 186
|
| Churchill, Liz
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 187
|
| Stang, Paul
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 188
|
| Trimble, Kathy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 189
|
| Goldberg, Steven
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 190
|
| Binzer, Peggy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 191
|
| Kilpatrick, Laura
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 192
|
| Parkinson, Edward
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 193
|
| Mettler, Erik
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 194
|
| Ring, John C.
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 195
|
| Warden, Beverly
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 196
|
| Robinette, John
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 197
|
| Walton, Marc
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 198
|
| Staffa, Judy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 199
|
| Cevasco, Kevin
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 200
|
| willy, mary
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 201
|
| Miller, Vail
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 202
|
| Zhan, Chunliu
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 203
|
| Beach, Kathleen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 204
|
| Weininger, Sandy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 205
|
| Melia, Richard
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 206
|
| Willis, David
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 207
|
| Matheny, Michael
|
| Vol #:
|
| 1
|
|
| |
|
| 2007N-0024
|
| Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing System and Storage Container
|
| |
|
|
| BKG 1
|
| Background
|
| Vol #:
|
| 1
|
| |
|
|
| NFR 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0036
|
| Agency Emergency Processing Under Office of Management and Budget Review; Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products; Labeling Comprehension Study
|
|
|
|
|
|
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
