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| Dockets Entered
On March 22, 2004
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
|
| 30-Day Structure Function
Claim Notification Letters Dietary
|
|
|
| 2001P-0075
|
| Switch Status of Emergency
Contraceptives from Rx to OTC
|
|
|
| 2003D-0554
|
| Compliance Policy Guide Sec. 110.310
Prior Notice of Imported Food Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002
|
|
| 2003D-0562
|
| Compliance Policy Guide Sec.110.300
Registration of Food Facilities Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids
in Nutrition Labeling; Consumer research to consider possible footnote
statements
|
|
| 2003N-0222
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| Agency Information Collection
Activities: Proposed Collection; Comment Request; Product Jurisdiction;
Assignment of Agency Component for Review of Premarket Applications
|
|
| 2003P-0555
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| Maintain the Electroconvulsive
Therapy Device in Class III for All Indications
|
|
| 2004D-0035
|
| Guidance for Industry on the Preclinical
and Clinical Evaluation of Agents Used in the Prevention or Treatment
of Postmenopausal Osteoporosis
|
|
|
|
|
|
|
|
| 1981N-0033P
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| Antiplaque &
Antiplaque-Related Claims
|
|
|
| EC 3
|
| Banks, Todd J.
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| Vol #:
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| 86
|
|
|
| 1993D-0398
|
| Microbiological Testing
Antimicrobial Drug Residues in Foods
|
|
|
| EC 2
|
| Ms. Mary Black
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| Vol #:
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| 1
|
|
|
| 1997S-0162
|
| 30-Day Structure
Function Claim Notification Letters Dietary
|
|
| LET
13340
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| Enzymatic Natural Medicines
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| Vol #:
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| 110
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|
|
| LET
13341
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| Enzymatic Therapy Naural
Medicines
|
| Vol #:
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| 110
|
|
|
| LET
13342
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| NutriSystem, Inc.
|
| Vol #:
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| 110
|
|
|
| LET
13343
|
| Enzymatic Therapy Natural
Medicines
|
| Vol #:
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| 110
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|
|
| LET
13344
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| PhytoPharmica Natural
Medicines
|
| Vol #:
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| 110
|
|
|
| LET
13345
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| Enzymatic Therapy Natural
Medicines
|
| Vol #:
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| 110
|
|
|
| LET
13346
|
| Integrative Therapeutics
Inc.
|
| Vol #:
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| 110
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|
|
| LET
13347
|
| Integrative Therapeutics
Inc.
|
| Vol #:
|
| 110
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|
|
| LET
13348
|
| Integrative Therapeutics
Inc,
|
| Vol #:
|
| 110
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|
|
| LET
13349
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| Integrative Therapeutics
Inc.
|
| Vol #:
|
| 110
|
|
|
| LET
13350
|
| Integrative Therapeutics
Inc.
|
| Vol #:
|
| 110
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|
|
| LET
13351
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| Integrative Therapeutics
Inc.
|
| Vol #:
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| 110
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|
|
| LET
13352
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| Integrative Therapeutics
Inc.
|
| Vol #:
|
| 110
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|
|
| LET
13353
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| Integrative Therapeutics
Inc.
|
| Vol #:
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| 110
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|
|
| LET
13354
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| Integrative Therapeutics
Inc.
|
| Vol #:
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| 110
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|
|
| LET
13355
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| Integrative Therapeutics
Inc.
|
| Vol #:
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| 110
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|
|
| LET
13356
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| Integrative Therapeutics
Inc.
|
| Vol #:
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| 110
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|
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| LET
13357
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| Integrative Therapeutics
Inc.
|
| Vol #:
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| 110
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|
|
| LET
13358
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| Intetrative Therapeutics
Inc.
|
| Vol #:
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| 110
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|
|
| LET
13359
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| Integrative Therapeutics
Inc.
|
| Vol #:
|
| 110
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|
|
| LET
13360
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| Integrative Therapeutics
Inc.
|
| Vol #:
|
| 110
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|
|
| LET
13361
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| Integrative Therapeutics
Inc.
|
| Vol #:
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| 110
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|
|
| LET
13362
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| Integrative Therapeutics
Inc.
|
| Vol #:
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| 110
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|
|
| LET
13363
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| Integrative Therapeutics
Inc.
|
| Vol #:
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| 110
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|
|
| LET
13364
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| Integrative Therapeutica
Inc.
|
| Vol #:
|
| 110
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|
|
| LET
13365
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| Integrative Therapeutics
Inc.
|
| Vol #:
|
| 110
|
|
| | | | | | | | |
|
|
| LET
13366
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| Integrative Therapeutics Inc.
|
| Vol #:
|
| 110
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|
|
| LET
13367
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| Integrative Therapeutics Inc.
|
| Vol #:
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| 110
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|
|
| LET
13368
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| Intetrative Therapeutics Inc.
|
| Vol #:
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| 110
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|
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| LET
13369
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| Integrative Therapeutics Inc.
|
| Vol #:
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| 110
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|
|
| LET
13370
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| Integrative Therapeutics Inc.
|
| Vol #:
|
| 110
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|
|
| LET
13371
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| Integrative Therapeutics Inc.
|
| Vol #:
|
| 110
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|
|
| LET
13372
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| Integrative Therapeutics Inc.
|
| Vol #:
|
| 110
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|
|
| LET
13373
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| Integrative Therapeutics Inc.
|
| Vol #:
|
| 110
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|
|
| LET
13374
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| Integrative Therapeutics Inc.
|
| Vol #:
|
| 110
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|
|
| LET
13375
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| Integrative Therapeutics Inc.
|
| Vol #:
|
| 110
|
|
|
| LET
13376
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| Integrative Therapeutics Inc.
|
| Vol #:
|
| 110
|
|
|
| LET
13377
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| Perrigo Company of South Carolina
|
| Vol #:
|
| 110
|
|
|
| LET
13378
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| Membrell, LLC
|
| Vol #:
|
| 110
|
|
|
| LET
13379
|
| Membrell, LLC
|
| Vol #:
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| 110
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
| C 370
|
| Form Letters
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| Vol #:
|
| 177
|
|
|
| C 371
|
| Form Letters
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| Vol #:
|
| 178
|
|
|
| C 372
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| Form Letters
|
| Vol #:
|
| 179
|
|
|
| C 373
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| Form Letters
|
| Vol #:
|
| 180
|
|
|
| C 374
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| Form Letters
|
| Vol #:
|
| 181
|
|
|
| C 375
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| Form Letters
|
| Vol #:
|
| 182
|
|
|
| C 376
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| Form Letters
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| Vol #:
|
| 183
|
|
|
| C 377
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| Form Letters
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| Vol #:
|
| 184
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|
|
| C 378
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| Form Letters
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| Vol #:
|
| 185
|
|
|
| C 379
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| Form Letters
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| Vol #:
|
| 186
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|
|
| C 380
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| Form Letters
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| Vol #:
|
| 187
|
|
|
| C 381
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| Form Letters
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| Vol #:
|
| 188
|
|
|
| C 382
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| Form Letters
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| Vol #:
|
| 189
|
|
|
| C 383
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| Form Letters
|
| Vol #:
|
| 190
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|
|
| C 384
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| Form Letters
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| Vol #:
|
| 191
|
|
|
| C 385
|
| Form Letters
|
| Vol #:
|
| 194
|
|
|
| C 386
|
| Form Letters
|
| Vol #:
|
| 195
|
|
|
| C 387
|
| Form Letters
|
| Vol #:
|
| 197
|
|
|
| C 388
|
| Form Letters
|
| Vol #:
|
| 198
|
|
|
| C 389
|
| T. Smith
|
| Vol #:
|
| 162
|
|
|
| C 390
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| J. Serda
|
| Vol #:
|
| 162
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|
| | | | | | | |
|
|
| C 391
|
| S. Long
|
| Vol #:
|
| 162
|
|
|
| C 392
|
| J. Long
|
| Vol #:
|
| 162
|
|
|
| C 393
|
| N. Bracy
|
| Vol #:
|
| 162
|
|
|
| C 394
|
| J. Butcher
|
| Vol #:
|
| 162
|
|
|
| C 395
|
| W. Ramey
|
| Vol #:
|
| 162
|
|
|
| C 396
|
| 13 signatures
|
| Vol #:
|
| 162
|
|
|
| C 397
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| 13 signatures
|
| Vol #:
|
| 162
|
|
|
| C 398
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| 13 signatures
|
| Vol #:
|
| 162
|
|
|
| C 399
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| 3 signatures
|
| Vol #:
|
| 162
|
|
|
| C 400
|
| 14 signatures
|
| Vol #:
|
| 162
|
|
|
| C
401
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| Pro-Life Office
|
| Vol #:
|
| 162
|
|
|
| C 402
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| P. Ritter, Jr.
|
| Vol #:
|
| 162
|
|
|
| C 403
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| H. Custodio
|
| Vol #:
|
| 162
|
|
|
| C 404
|
| Illegible
|
| Vol #:
|
| 162
|
|
|
| C 405
|
| M. Carr
|
| Vol #:
|
| 162
|
|
|
| C 406
|
| T. Lober
|
| Vol #:
|
| 162
|
|
|
| C 407
|
| R. Lober
|
| Vol #:
|
| 162
|
|
|
| C 408
|
| M. Lober
|
| Vol #:
|
| 162
|
|
|
| C 409
|
| J. Lober
|
| Vol #:
|
| 162
|
|
|
| C 410
|
| P. Lober
|
| Vol #:
|
| 162
|
|
|
| C 411
|
| T. Washeba
|
| Vol #:
|
| 162
|
|
|
| C 412
|
| M. Norton
|
| Vol #:
|
| 162
|
|
|
| C 413
|
| C. Buonopane
|
| Vol #:
|
| 162
|
|
|
| C 414
|
| R. Mauro
|
| Vol #:
|
| 162
|
|
|
| C 415
|
| L. Mauro
|
| Vol #:
|
| 162
|
|
|
| C 416
|
| P. Schiller, RN
|
| Vol #:
|
| 162
|
|
|
| C 417
|
| S. Schiller
|
| Vol #:
|
| 162
|
|
|
| C 418
|
| L.L. Pallos, PhD
|
| Vol #:
|
| 162
|
|
|
| C 419
|
| S. Blanchard
|
| Vol #:
|
| 162
|
|
|
| C 420
|
| B. Blanchard
|
| Vol #:
|
| 162
|
|
|
| C 421
|
| L. Lavoie
|
| Vol #:
|
| 162
|
|
|
| C 422
|
| P. Reed
|
| Vol #:
|
| 162
|
|
|
| C 423
|
| D. Nealon
|
| Vol #:
|
| 162
|
|
|
| C 424
|
| R. Martin
|
| Vol #:
|
| 162
|
|
|
| C
425
|
| Medical Arts Associates, Ltd
|
| Vol #:
|
| 162
|
|
|
| C 426
|
| R. Grossman, MD
|
| Vol #:
|
| 162
|
|
|
| C 427
|
| B. Peters, MD
|
| Vol #:
|
| 162
|
|
| | | | | | | |
|
|
| C
428
|
| American Academy of Pediatrics (AAP)
|
| Vol #:
|
| 162
|
|
|
| C
429
|
| Columbia University
|
| Vol #:
|
| 162
|
|
|
| C
430
|
| Women's Health Practice
|
| Vol #:
|
| 162
|
|
|
| C 431
|
| S. Jacobson, MD
|
| Vol #:
|
| 162
|
|
|
| C 432
|
| S. McIsaac, MD
|
| Vol #:
|
| 162
|
|
|
| C 433
|
| M. Whang
|
| Vol #:
|
| 162
|
|
|
| C 434
|
| T. Ault
|
| Vol #:
|
| 162
|
|
|
| C 435
|
| J. Pozar, RN
|
| Vol #:
|
| 162
|
|
|
| C 436
|
| M. Creinin, MD
|
| Vol #:
|
| 162
|
|
|
| C 437
|
| E. Elizabeth Simoneau
|
| Vol #:
|
| 162
|
|
|
| C 438
|
| S. Epstein
|
| Vol #:
|
| 162
|
|
|
| C 439
|
| H. Stutman
|
| Vol #:
|
| 162
|
|
|
| C 440
|
| H. Russell
|
| Vol #:
|
| 162
|
|
|
| C 441
|
| J. Maggs, PhD
|
| Vol #:
|
| 162
|
|
|
| C 442
|
| M. Mossman
|
| Vol #:
|
| 162
|
|
|
| C 443
|
| M. Mossman
|
| Vol #:
|
| 162
|
|
|
| C 444
|
| R. Seymour
|
| Vol #:
|
| 162
|
|
|
| C 445
|
| C. Briscoe
|
| Vol #:
|
| 162
|
|
|
| C 446
|
| C. Schmidt
|
| Vol #:
|
| 162
|
|
|
| C 447
|
| J. A Schmidt
|
| Vol #:
|
| 162
|
|
|
| C 448
|
| P. Forcier
|
| Vol #:
|
| 162
|
|
|
| C 449
|
| M. Pesarchick
|
| Vol #:
|
| 162
|
|
|
| C 450
|
| R. Towsley
|
| Vol #:
|
| 162
|
|
|
| C 451
|
| M. Pesarchick
|
| Vol #:
|
| 162
|
|
|
| C
452
|
| Univeristy of Rochester
|
| Vol #:
|
| 162
|
|
|
| C 453
|
| E. Pearce
|
| Vol #:
|
| 162
|
|
|
| C 454
|
| S. Ruby
|
| Vol #:
|
| 162
|
|
|
| C
455
|
| Boston University School of Medicine
|
| Vol #:
|
| 162
|
|
|
| C
456
|
| Duke University Medical Center
|
| Vol #:
|
| 162
|
|
|
| C 457
|
| W. Ho
|
| Vol #:
|
| 162
|
|
|
| C 458
|
| N. Guinn, MD
|
| Vol #:
|
| 162
|
|
|
| C 459
|
| E. Perrin, MD
|
| Vol #:
|
| 162
|
|
|
| C 460
|
| J. Curington, MD
|
| Vol #:
|
| 162
|
|
|
| C
461
|
| Lawrence Family Medicine & Obstetrics
|
| Vol #:
|
| 162
|
|
|
| C
462
|
| Westside Regional Center
|
| Vol #:
|
| 162
|
|
|
| C
463
|
| Physicians to Women, Inc.
|
| Vol #:
|
| 162
|
|
|
| C 464
|
| E. Godfrey,MD,MPH
|
| Vol #:
|
| 162
|
|
| | | | | | | | |
|
|
| C 465
|
| S. Sklar, MD
|
| Vol #:
|
| 162
|
|
|
| C
466
|
| Univeristy of California San Francisco
|
| Vol #:
|
| 162
|
|
|
| C 467
|
| R. Rupp, MD
|
| Vol #:
|
| 162
|
|
|
| C
468
|
| Physicians for Reproductive Choice and Health
|
| Vol #:
|
| 162
|
|
|
| C
469
|
| University of Pennsylvania Health System
|
| Vol #:
|
| 162
|
|
|
| C
470
|
| University of Minnesota
|
| Vol #:
|
| 162
|
|
|
| C
471
|
| Bowdoin College
|
| Vol #:
|
| 162
|
|
|
| C
472
|
| New Jersey Medical School
|
| Vol #:
|
| 162
|
|
|
| C 473
|
| K. LeFevre
|
| Vol #:
|
| 162
|
|
|
| C 474
|
| H. Brown, MD
|
| Vol #:
|
| 162
|
|
|
| C 475
|
| Richard B. Braunstein, MD, Inc.
|
| Vol #:
|
| 162
|
|
|
| C 476
|
| P. Palm,MS,RNC
|
| Vol #:
|
| 162
|
|
|
| C 477
|
| Illegible
|
| Vol #:
|
| 162
|
|
|
| C 478
|
| S. Morian
|
| Vol #:
|
| 162
|
|
|
| C 479
|
| M. Paul
|
| Vol #:
|
| 162
|
|
|
| C 480
|
| L. Baker
|
| Vol #:
|
| 162
|
|
|
| C 481
|
| G. Jacobson, MD
|
| Vol #:
|
| 162
|
|
|
| C 482
|
| B. Peters, MD
|
| Vol #:
|
| 162
|
|
|
| EC 604
|
| Dr. Angela Allerman
|
| Vol #:
|
| 163
|
|
|
| EC 605
|
| Texas Christian University
|
| Vol #:
|
| 163
|
|
|
| EC 606
|
| Ms. ruth anne rosenberg
|
| Vol #:
|
| 163
|
|
|
| EC 607
|
| Mr. Russell Shaw
|
| Vol #:
|
| 163
|
|
|
| EC 608
|
| Ms. nancy ferguson
|
| Vol #:
|
| 163
|
|
|
| 2002D-0428
|
| Information for the use of Human Blood & Blood Components
|
|
|
| EC 2
|
| McGinnis, William
|
| Vol #:
|
| 1
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
| EC 348
|
| Rosenblum, Charles
|
| Vol #:
|
| 20
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
| EC 385
|
| Rosenblum, Charles
|
| Vol #:
|
| 22
|
|
|
| EC 386
|
| terstiege, gerard
|
| Vol #:
|
| 22
|
|
|
| EC 387
|
| Leitner, John A.
|
| Vol #:
|
| 22
|
|
|
| 2003D-0092
|
| Food and Cosmetic Security Guidances
|
|
|
| EC 19
|
| Prashant, Singamsetti
|
| Vol #:
|
| 1
|
|
|
| 2003D-0290
|
| Compounding of Drugs for Use in Animals Compliance Policy Guide
|
|
| | | | | | | | |
|
|
| EC 14
|
| Mrs. Virginia Collins
|
| Vol #:
|
| 1
|
|
|
| 2003D-0386
|
| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
|
|
|
| EC 1
|
| Rockel, Cynthia
|
| Vol #:
|
| 1
|
|
|
| 2003D-0478
|
| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
|
|
|
| EC 23
|
| Mrs. Gail Tanner
|
| Vol #:
|
| 5
|
|
|
| 2003D-0498
|
| Compliance Program Guidance Manual 7371.009; BSE/Ruminant Feed Ban Inspections; Availability
|
|
|
| EC 8
|
| McGinnis, William
|
| Vol #:
|
| 1
|
|
|
| EC 9
|
| Mrs. penina serour
|
| Vol #:
|
| 1
|
|
|
| 2003D-0545
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| Questions and Answers Regarding Registration of Food Facilities
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|
|
| EC 3
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| Mrs. Selina Hughes
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| Vol #:
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| 1
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|
|
| EC 4
|
| student student
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| Vol #:
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| 1
|
|
|
| 2003D-0554
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| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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|
|
| EC 2
|
| Bacardi- Martini Product Development
|
| Vol #:
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| 1
|
|
|
| EC 3
|
| Bacardi-Martini Product Development, Inc.
|
| Vol #:
|
| 1
|
|
|
| EC 4
|
| Mr. Ted Bateh
|
| Vol #:
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| 1
|
|
|
| 2003D-0558
|
| Guidance Levels for Radionuclides in Domestic and Imported Foods
|
|
|
| EC 2
|
| generette, lloyd
|
| Vol #:
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| 1
|
|
|
| 2003D-0562
|
| Compliance Policy Guide Sec.110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
|
|
| EC 1
|
| www.mdzx.com, offshorepharmacy.com
|
| Vol #:
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| 1
|
|
|
| 2003E-0245
|
| Patent Extension for Remodulin (Treprostinil sodium), 5,153,222
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|
|
| EC 1
|
| Maebius, Stephen
|
| Vol #:
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| 1
|
|
|
| 2003N-0069
|
| FDA Task Force on Consumer Health Info for Better Nutrition
|
|
|
| EC 92
|
| Whitney, Lucile
|
| Vol #:
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| 5
|
|
|
| EC 93
|
| Mrs. Rebecca Mount
|
| Vol #:
|
| 5
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| EC 8
|
| Mr. Christopher Czerwonka
|
| Vol #:
|
| 3
|
|
|
| EC 9
|
| Northland Cranberries, Inc.
|
| Vol #:
|
| 3
|
|
|
| EC 10
|
| Mr. Jeffrey Schultz
|
| Vol #:
|
| 3
|
|
|
| 2003N-0222
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Product Jurisdiction; Assignment of Agency Component for Review of Premarket Applications
|
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
|
|
| EC 9
|
| kravitz, yvonne
|
| Vol #:
|
| 1
|
|
|
| EC 10
|
| kravitz, melvin
|
| Vol #:
|
| 1
|
|
|
| EC 11
|
| kravitz, martha
|
| Vol #:
|
| 1
|
|
|
| EC 12
|
| levy, cacilie
|
| Vol #:
|
| 1
|
|
|
| EC 13
|
| kravitz, cynthia
|
| Vol #:
|
| 1
|
|
|
| EC 14
|
| Disability Rights Center
|
| Vol #:
|
| 1
|
|
|
| EC 15
|
| Mr. Frederick Dorman
|
| Vol #:
|
| 1
|
|
|
| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
|
|
| EC 2
|
| Johnston, Kathy Keithley
|
| Vol #:
|
| 1
|
|
|
| EC 3
|
| Walker, J
|
| Vol #:
|
| 1
|
|
|
| 2004D-0028
|
| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
|
|
| EC 2
|
| Mills, Krista
|
| Vol #:
|
| 1
|
|
|
| EC 3
|
| Mrs. pnina srour
|
| Vol #:
|
| 1
|
|
|
| EC 4
|
| Mr. revJ.Lee Osborne
|
| Vol #:
|
| 1
|
|
|
| EC 5
|
| Ms. Julia Shrader-Lauinger
|
| Vol #:
|
| 1
|
|
|
| EC 6
|
| Dr. John Stea
|
| Vol #:
|
| 1
|
|
|
| EC 7
|
| Mrs. Michelle Yamada
|
| Vol #:
|
| 1
|
|
|
| 2004D-0035
|
| Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
|
|
|
| EC 1
|
| Perceptive Informatics, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
|
|
| EC 1
|
| Mr. Paul Warburton
|
| Vol #:
|
| 1
|
|
|