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| Dockets Entered
On December 5, 2006
Table of Contents
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| Docket #
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| Title
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-4613
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| Revoke the Regulation That Approved Posilac
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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-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2003V-0306
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| Laser Light Show
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| 2005D-0356
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| Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| 2005P-0383
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| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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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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| 2006D-0303
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| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006N-0414
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| Suicidality Data from Adult Antidepressant Trials
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| 2006N-0464
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| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
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| 2006P-0158
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| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
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| 2006P-0369
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| ANDA Suitability for Alclometasone Dipropionate Lotion, 0.05%
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| 2006P-0371
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| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0403
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| Determine whether an Abbreviated New Drug Application can be filed against the listed drug Novamine 15%, manufactured by Hospira under NDA 17-957
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| 2006P-0484
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| Change the indication for Stimulant Medications for the Treatment of Mental Diseases
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| 2006P-0498
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| Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods
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| 2006V-0499
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| Laser Light Show
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| |
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 661
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| S. Jannarone
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| Vol #:
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| 24
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| 1999P-4613
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| Revoke the Regulation That Approved Posilac
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| EMC 2432
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| University of Phoenix-Atlanta, Georgia
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| Vol #:
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| 46
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| EMC 2433
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| T. White
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| Vol #:
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| 46
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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 1389
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| R. Coleman
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| Vol #:
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| 12
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| EMC 1390
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| M. Zimmer
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| Vol #:
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| 12
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| EMC 1391
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| J. & R. Sperbeck
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| Vol #:
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| 12
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| EMC 1392
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| J. & R. Sperbeck
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| Vol #:
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| 12
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| EC
30
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| Mrs. Tamara Wilhite
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| Vol #:
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| 8
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| 2003V-0306
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| Laser Light Show
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| VRA 2
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| FDA/CDRH to Visiotopic Systems LLC`
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| Vol #:
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| 1
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| 2005D-0356
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| Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records
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| EC
5
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| Mrs. Tamara Wilhite
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| Vol #:
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| 1
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| EC
21
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| Mrs. Tamara Wilhite
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| Vol #:
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| 1
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| 2005P-0383
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| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
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| ACK 2
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| FDA/DDM to Savient Pharmaceuticals Inc
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| Vol #:
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| 1
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| PRC 1
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| Savient Pharmaceuticals Inc
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| EMC 4157
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| V. George
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| Vol #:
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| 195
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| EMC 4158
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| S. Martin
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| Vol #:
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| 195
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| EMC 4159
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| C. McCann
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| Vol #:
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| 195
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| EMC 4160
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| D. Farren
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| Vol #:
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| 195
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| EMC 4161
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| D. Haggard
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| Vol #:
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| 195
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| EMC 4162
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| L. Dilley
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| Vol #:
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| 195
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| EMC 4163
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| D. Roper
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| Vol #:
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| 195
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| EMC 4164
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| C. DePiano
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| Vol #:
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| 195
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| EMC 4165
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| S. O'Connor
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| Vol #:
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| 195
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| EMC 4166
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| M. Holden
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| Vol #:
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| 195
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| EMC 4167
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| Y. Patch
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| Vol #:
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| 195
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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| EMC 8
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| A. Hill
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| Vol #:
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| 7
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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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| SUP 1
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| R DeWitty
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| Vol #:
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| 2
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| 2006D-0303
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| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
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|
|
|
|
| EC
3
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| Mrs. Tamara Wilhite
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| Vol #:
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| 1
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| | | | | | | | |
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| EMC 1150
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| L. Sledge
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| Vol #:
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| 24
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| EMC 1151
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| P. Bullington
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| Vol #:
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| 24
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| EMC 1152
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| M. Hanson
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| Vol #:
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| 24
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| EMC 1153
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| M. Hanson
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| Vol #:
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| 24
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| EMC 1154
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| F. Berglund
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| Vol #:
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| 24
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| 2006N-0414
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| Suicidality Data from Adult Antidepressant Trials
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| C
4
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| Alliance for Human Research Protection (AHRP)
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| Vol #:
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| 1
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| C 5
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| P Breggin MD
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| Vol #:
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| 1
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| C 6
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| G Todovich
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| Vol #:
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| 1
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| C 7
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| F Lahman
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| Vol #:
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| 1
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| C 8
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| E Hanson
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| Vol #:
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| 1
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| C 9
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| H Patenaude
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| Vol #:
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| 1
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| EMC 2
Published
Material
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| The International Center for The Study of Psychiatry & Phychology
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| Vol #:
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| 2
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| EMC 3
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| V. Sharav
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| Vol #:
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| 2
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| EMC 4
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| V. Sharav
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| Vol #:
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| 2
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| EMC 5
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| L. Milanese
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| Vol #:
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| 2
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| EMC
6
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| Pfizer Inc
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| Vol #:
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| 2
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| EMC 7
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| D. Tucker
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| Vol #:
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| 2
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| EMC 8
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| C. Harter
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| Vol #:
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| 2
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| EMC 9
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| N. Brownlow
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| Vol #:
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| 2
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| EMC 10
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| A. Warwick
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| Vol #:
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| 2
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| EMC 11
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| A. Warwick
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| Vol #:
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| 2
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| EMC 12
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| F. Merritt
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| Vol #:
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| 2
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| EMC
13
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| The International Center for The Study of Phychiatry & Phychology
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| Vol #:
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| 2
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| 2006N-0464
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| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
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| EC 2
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| AGA Medical
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| Vol #:
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| 1
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| 2006P-0158
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| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
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| EMC 90
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| L. Foster
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| Vol #:
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| 1
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| EMC 91
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| K. Abbas
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| Vol #:
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| 1
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| EMC 92
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| K. McCluskey
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| Vol #:
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| 1
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| EMC 93
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| C. Crusha
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| Vol #:
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| 1
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| EMC 94
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| M. Thrantell
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| Vol #:
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| 1
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| EMC 95
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| P. Tomlin
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| Vol #:
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| 1
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| EMC 96
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| K. Meyers
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| Vol #:
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| 1
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| EMC 97
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| S. Weyand
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| Vol #:
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| 1
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| EMC 98
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| G. Gohr
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| Vol #:
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| 1
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| EMC 99
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| K. Knudsen
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| Vol #:
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| 1
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| |
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| 2006P-0369
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| ANDA Suitability for Alclometasone Dipropionate Lotion, 0.05%
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| AMD 1
|
| Kirkpatrick & Lockhart Nicholson Graham LLP
|
| Vol #:
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| 1
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| 2006P-0371
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| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
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|
|
|
|
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| EC
11
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| Ms. Nancy Thompson
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| Vol #:
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| 1
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| EC
433
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| Miss. Rosemary Wike
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| Vol #:
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| 7
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| EC
434
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| Mrs. Joyce Janicki
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| Vol #:
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| 7
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| EC
435
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| Ms. Deborah Romero
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| Vol #:
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| 7
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| 2006P-0403
|
| Determine whether an Abbreviated New Drug Application can be filed against the listed drug Novamine 15%, manufactured by Hospira under NDA 17-957
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| AMD 1
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| B Braun Medical
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| Vol #:
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| 1
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| 2006P-0484
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| Change the indication for Stimulant Medications for the Treatment of Mental Diseases
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| EC 1
|
| Mrs. Tamara Wilhite
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| Vol #:
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| 1
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| 2006P-0498
|
| Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods
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| ACK 1
|
| FDA/DDM to Center for Science in the Public Interest
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| Vol #:
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| 1
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| CP 1
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| Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 1
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| |
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| 2006V-0499
|
| Laser Light Show
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| ACK 1
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| FDA/DDM to Des Monies Astronomical Society, Inc.
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| Vol #:
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| 1
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| VAR 1
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| Des Monies Astronomical Society, Inc.
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| Vol #:
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| 1
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