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| Dockets Entered
On July 5, 2006
Table of Contents
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| Docket #
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| Title
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| 1998N-0046
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| Comprehensive List of Current Guidance Documents at FDA
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| 2001D-0489
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| Establishment & Operation of Clinical Trial Monitoring Comm
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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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| 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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| 2004D-0283
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| Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
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| 2004E-0396
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| Patent Extension for TAXUS EXPRESS (Paclitaxel-Eluting Coronary Stent System)
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| 2005D-0004
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| Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations
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| 2005D-0103
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| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
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| 2005E-0238
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| Patent Extension Application for TYSABRI (natalizumab), U.S. Patent No. 5,840,299
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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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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| 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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| 2006D-0254
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| Guidance for Industry: Analytical Methods Description for Type C Medicated Feeds
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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| 2006N-0109
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| General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities
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| 2006P-0068
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| Determine whether Syntocinon (oxytocin) Nasal Spray NDA 12-285, has been voluntarily withdrawn for safety or effectiveness reasons
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| 2006P-0126
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| Take specific actions with regard to the animal product that is manufactured by S&M NuTec LLC known as a "Greenie".
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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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-0242
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| Approval of any Budesonide Inhalation Suspension Product using Pulmicort Respules
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| 2006P-0245
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| Exclusivity Determination for Risperidone
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| 1998N-0046
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| Comprehensive List of Current Guidance Documents at FDA
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| EC 8
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| EC 9
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| 2001D-0489
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| Establishment & Operation of Clinical Trial Monitoring Comm
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| EC 15
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| Mr. Dave Lowe
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| Vol #:
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| 2
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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 1327
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| J. Anderson
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| Vol #:
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| 6
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 668
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| Mission Possible International
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| Vol #:
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| 10
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| EMC 669
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| Calorie Control Council
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| Vol #:
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| 10
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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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| C 40
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| E. Guie
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| Vol #:
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| 10
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| EMC 1316
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| Amy
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| Vol #:
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| 12
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| EMC 1317
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| K. Krever, MD
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| Vol #:
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| 12
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| EMC 1318
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| D. Davidek
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| Vol #:
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| 12
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| EMC 1319
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| E. Burritt
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| Vol #:
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| 12
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| EMC 1320
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| A. Barnswell
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| Vol #:
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| 12
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| 2004D-0283
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| Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
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| EC 6
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2004E-0396
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| Patent Extension for TAXUS EXPRESS (Paclitaxel-Eluting Coronary Stent System)
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| EC 9
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2005D-0004
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| Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations
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| EC 9
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2005D-0103
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| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
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| EC 8
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| Mr. David Lowe
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| Vol #:
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| 1
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| EC 9
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2005E-0238
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| Patent Extension Application for TYSABRI (natalizumab), U.S. Patent No. 5,840,299
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| EMC 1
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| P. Doherty
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| Vol #:
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| 1
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| EMC 2
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| K. Nordlund
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| Vol #:
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| 1
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| RMO 6
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| FDA/CDRH/OGC
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| Vol #:
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| 6
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| RMO 7
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| FDA/CDRH/OGC
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| Vol #:
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| 6
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| RMO 8
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| TMJ Implants Inc. and Robert W. Christensen and Maureen K Mooney
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| Vol #:
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| 6
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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 589
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| AstraZeneca
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| Vol #:
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| 15
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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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