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| Dockets Entered
On December 20, 2005
Table of Contents
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1999N-1075
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| Vibrio Parahaemolyticus in molluscan shellfish public health
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0273
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Research Study Complaint Form
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2004P-0297
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| Nutrient Content Claim: Define Terms Low Carbohydrate, Reduced Carbohydrate and Carbohydrate Free
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| 2005D-0340
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| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
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| 2005D-0385
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| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0364
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| Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| 2005P-0495
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| Dietary supplement VI-28 TM clarifying, in writing, whether or not the dietary supplement , as detailed in the pre-market notification filed 18 August 2005
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| 2005P-0496
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| ANDA Suitability for Irinotecan Hydrochloride Injection, 20 mg/mL
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| 2005P-0498
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| Criteria of generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets)
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT
298
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| Albion Laboratories Inc
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| Vol #:
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| 233
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| RPT
299
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| Natural ASA
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| Vol #:
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| 234
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| RPT
300
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| Access Business Group
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| Vol #:
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| 238
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| RPT
301
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| Biocodex Inc
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| Vol #:
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| 239
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| RPT
302
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| pH Sciences Inc
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| Vol #:
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| 230
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| 1999N-1075
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| Vibrio Parahaemolyticus in molluscan shellfish public health
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| TR
4
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| Transcript of the August 13, 2005 Meeting
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| Vol #:
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| 27
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| EMC 3
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| Diane
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| Vol #:
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| 1
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| EMC 4
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| B. Sachau
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| Vol #:
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| 1
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| EMC 1300
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| M. Dows
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| Vol #:
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| 6
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| C
428
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| Australian Government
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| Vol #:
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| 36
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| C 429
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| M. Peppercorn, MD
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| Vol #:
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| 36
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| C 430
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| B. Robinson
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| Vol #:
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| 36
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| C 431
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| D. Rosenstein
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| Vol #:
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| 36
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| C 432
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| Illegible
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| Vol #:
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| 36
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| C
433
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| American Veterinary Medical Association (AVMA)
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| Vol #:
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| 36
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| C
434
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| Griffin Industries, Inc.
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| Vol #:
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| 36
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| C
435
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| Government of Japan
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| Vol #:
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| 36
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| C
436
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| Valley Proteins, Inc.
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| Vol #:
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| 36
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| C 437
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| Mr and Mrs R. Nelson
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| Vol #:
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| 36
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| C 438
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| M. Howard
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| Vol #:
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| 36
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| C 439
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| G. White
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| Vol #:
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| 36
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| C
440
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| Honorable Steve King
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| Vol #:
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| 36
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| C 441
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| S. Frantz, MD
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| Vol #:
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| 39
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| C 442
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| L. Lucas
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| Vol #:
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| 39
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| C 443
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| S. Craig
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| Vol #:
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| 39
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| C 444
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| C. Grace
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| Vol #:
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| 39
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| C 445
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| J. Buning
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| Vol #:
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| 39
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| C 446
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| M. Glowacki
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| Vol #:
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| 39
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| C 447
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| R. Vidinha
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| Vol #:
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| 39
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| C 448
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| J. Hale
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| Vol #:
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| 39
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| C 449
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| C. Tanaka
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| Vol #:
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| 39
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| C 450
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| J and C Bryan
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| Vol #:
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| 39
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| C 451
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| L. Colvin
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| Vol #:
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| 36
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| C
452
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| Mississippi Farm Bureau Federation (MFBF)
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| Vol #:
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| 39
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| C
453
Attachment
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| Virginia Department of Environmental Quality
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| Vol #:
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| 39
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| |
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 569
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| Mission Possible International
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| Vol #:
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| 8
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| EMC 570
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| Mission Possible International
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| Vol #:
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| 8
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| EMC 571
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| Mission Possible International
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| Vol #:
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| 8
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| EMC
572
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| Calorie Control Council
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| Vol #:
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| 8
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| EMC 573
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| Mission Possible International
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| Vol #:
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| 8
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| EMC 574
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| Mission Possible International
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| Vol #:
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| 8
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1177
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| D. Milligan
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| Vol #:
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| 12
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| 2003N-0273
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Research Study Complaint Form
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| EMC 2
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| B. Sachau
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| Vol #:
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| 1
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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|
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|
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| EMC 3
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| Diane
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| Vol #:
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| 1
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| EMC 4
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| B. Sachau
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| Vol #:
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| 1
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| EMC 78
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| G. Norris
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| Vol #:
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| 2
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| 2004P-0297
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| Nutrient Content Claim: Define Terms Low Carbohydrate, Reduced Carbohydrate and Carbohydrate Free
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| LET
4
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| Center for Science In The Public Interest
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| Vol #:
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| 3
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| 2005D-0340
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| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
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| EMC
1
Attachment
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| Coria Laboratories, LTD
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| Vol #:
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| 1
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| 2005D-0385
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| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
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| EMC
3
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| Johnson & Johnson
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| Vol #:
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| 1
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| EMC
75
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| Society for Women's Health Research
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| Vol #:
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| 4
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| EMC 76
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| W. Bradford, PhD
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| Vol #:
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| 4
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| 2005N-0364
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| Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting
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| LST
1
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| Agenda for November 17, 2005 Stakeholder Meeting
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| Vol #:
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| 1
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| 2005N-0394
|
| FDAs Communication of Drug Safety Information; Public Hearing
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| TS
21
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| Pfizer
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| Vol #:
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| 2
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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| EMC
1
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| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 1
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| 2005P-0495
|
| Dietary supplement VI-28 TM clarifying, in writing, whether or not the dietary supplement , as detailed in the pre-market notification filed 18 August 2005
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| ACK
1
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| Vigconic (International), Ltd.
|
| Vol #:
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| 1
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| CP 1
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| Vigconic (International), Ltd.
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| Vol #:
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| 1
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| 2005P-0496
|
| ANDA Suitability for Irinotecan Hydrochloride Injection, 20 mg/mL
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| ACK
1
|
| HFA-305 to Mayne Pharma (USA) Inc.
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| Vol #:
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| 1
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| CP
1
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| Mayne Pharma (USA) Inc.
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| Vol #:
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| 1
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