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Dockets Management
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| Dockets Entered On June
27, 2006
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000D-1306
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| Content & Format of the Adverse Reactions Section of Labeling
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| 2001D-0269
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| Clinical Studies Section for Prescription Drugs & Biologics
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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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| 2002D-0260
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| Prescription drug Samples to Free Clinics
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2003D-0549
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| Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision
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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-0355
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| Medical Devices; Exception from General Requirements for Informed Consent
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004P-0513
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| to amend regulation update 'Estrogens Increase The Risk of Endometrial Cancer prescribing info of all strengths of Premarin tablets
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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-0385
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| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
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| 2005P-0295
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| Standard Identity for Pure Birch Syrup and Birch Breakfast Style Syrup
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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-0088
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| Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
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| 2006D-0268
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| Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations
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| 2006E-0042
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| Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243
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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-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| 2006P-0146
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| Amend Reg. for Prescription Drug Advertising to Establish Separate Criteria for Practitioner-Directed & Consumer-Directed Advertising and Establish Advisory Committee
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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-0177
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| ANDA Suitability for Methotrexate
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| 2006P-0209
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| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
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| 2006P-0224
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| Take appropriate remedial action against the apparent misbranding of generic azithromycin marketed by Pliva, Inc.
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| 2006P-0243
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| Qualified Health Claim: (QHC) Corn oil and corn oil containing foods and heart disease
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| 2006P-0245
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| Exclusivity Determination for Risperidone
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| 2006P-0251
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| Label change or removal from the market of the psychotropic drug Depakote
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| 2006P-0258
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| Immediately approve ANDA No. 77-837 upon the June 23, 2006 patent expiration of U.S. Patent No. 4,444,784
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| 2006P-0271
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| Amend practice of assessing the performance of medical devices for determining in vitro susceptibility of bacteria or fungi to included CLSI.
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| 2006V-0269
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| Laser Light Show
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| 2006V-0270
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| Laser Light Show
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 17959
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| Sunrider International
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| Vol #:
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| 165
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| LET 17960
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| Sunrider International
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| Vol #:
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| 165
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| LET 17961
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| Sunrider International
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| Vol #:
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| 165
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| LET 17962
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| Sunrider International
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| Vol #:
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| 165
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| LET 17963
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| Sunrider International
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| Vol #:
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| 165
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| LET 17964
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| Sunrider International
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| Vol #:
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| 165
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| LET 17965
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| Sunrider International
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| Vol #:
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| 165
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| LET 17966
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| Sunrider International
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| Vol #:
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| 165
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| LET 17967
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| Sunrider International
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| Vol #:
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| 165
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| LET 17968
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| Sunrider International
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| Vol #:
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| 165
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| LET 17969
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| Sunrider International
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| Vol #:
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| 165
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| 2000D-1306
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| Content & Format of the Adverse Reactions Section of Labeling
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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. David Lowe
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| Vol #:
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| 1
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| EC 10
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| Ms. audrey wildman
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| Vol #:
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| 1
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| 2001D-0269
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| Clinical Studies Section for Prescription Drugs & Biologics
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| EC 2
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2001D-0489
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| Establishment & Operation of Clinical Trial Monitoring Comm
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| EC 14
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| Mrs. Wendy Davis
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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 1326
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| B and W McAuley
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| Vol #:
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| 6
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| 2002D-0260
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| Prescription drug Samples to Free Clinics
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 667
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| Mission Possible International
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| Vol #:
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| 10
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| EC 24
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| Mr. Dave Lowe
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| Vol #:
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| 5
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| 2003D-0549
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| Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision
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| EC 1
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| Mr. David Lowe
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| Vol #:
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| 1
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| EC 2
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| Mr. David Lowe
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| Vol #:
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| 1
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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 1311
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| K. Western
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| Vol #:
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| 12
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| EMC 1312
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| S. Unks
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| Vol #:
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| 12
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| EMC 1313
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| D. Murray
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| Vol #:
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| 12
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| EMC 1314
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| D. Murray
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| Vol #:
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| 12
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| EMC 1315
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| V. Gilovich
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| Vol #:
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| 12
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| 2003N-0355
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| Medical Devices; Exception from General Requirements for Informed Consent
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| EC 5
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| Mrs. Susan Pearce
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| Vol #:
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| 1
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| EMC 1565
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| Number Not Used
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| Vol #:
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| 22
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| EMC 1566
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| B. Sachau
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| Vol #:
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| 22
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| 2004P-0513
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| to amend regulation update 'Estrogens Increase The Risk of Endometrial Cancer prescribing info of all strengths of Premarin tablets
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| EC 1
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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 7
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| EC 8
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| Mr. Dave Lowe
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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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| EC 10
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2005P-0295
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| Standard Identity for Pure Birch Syrup and Birch Breakfast Style Syrup
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| ANS 1
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| FDA/CFSAN to AK Birch Syrupmakers Association
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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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| C 13666
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| J. Wendche
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| Vol #:
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| 158
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| C 13667
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| K. Turner
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| Vol #:
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| 158
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| C 13668
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| S. Jaenchen
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| Vol #:
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| 158
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| C 13669
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| 56 signatures
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| Vol #:
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| 158
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| C 13670
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| D. Canavan
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| Vol #:
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| 158
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| C 13671
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| M. Caspaly
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| Vol #:
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| 158
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| C 13672
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| Y. Minslow
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| Vol #:
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| 158
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| C 13673
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| J. Madsen-Kuler
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| Vol #:
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| 158
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| C 13674
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| L. A. Eakle
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| Vol #:
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| 158
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| C 13675
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| J. Compeaux
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| Vol #:
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| 158
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| C 13676
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| S. Cheramz
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| Vol #:
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| 158
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| C 13677
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| H. J. Chermz III
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| Vol #:
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| 158
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| | | | | | | | |
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| EMC 2872
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| S. Wildemuth
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| Vol #:
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| 157
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| 2006D-0088
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| Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
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| EMC 1
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| NIAID
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| Vol #:
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| 1
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| 2006D-0268
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| Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations
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| EMC 1
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| R. Reinhard
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| Vol #:
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| 1
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| 2006E-0042
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| Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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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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| EC 2
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| UNTHSC-FW
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| Vol #:
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| 1
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| EC 3
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| The Ohio State University Medical Center
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| Vol #:
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| 1
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| EC 4
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| Regions Hospital
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| Vol #:
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| 1
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| EC 5
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| The Ohio State University
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| Vol #:
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| 1
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| EC 11
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006P-0146
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| Amend Reg. for Prescription Drug Advertising to Establish Separate Criteria for Practitioner-Directed & Consumer-Directed Advertising and Establish Advisory Committee
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 2
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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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| EC 2
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| Command Trust Network
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| Vol #:
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| 1
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| 2006P-0177
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| ANDA Suitability for Methotrexate
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| EC 2
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| EC 3
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006P-0209
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| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
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| EC 1
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| Mr. D Lowe
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| Vol #:
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| 1
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| EC 2
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| Mr. David Lowe
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| Vol #:
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| 1
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| EC 3
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| EC 4
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| EC 5
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| Mr. Dave Lowe
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| Vol #:
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| 1
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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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| 2006P-0224
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| Take appropriate remedial action against the apparent misbranding of generic azithromycin marketed by Pliva, Inc.
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| EC 1
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| Mr. D Lowe
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| Vol #:
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| 1
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| EC 2
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| | | | | | | | |
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| 2006P-0243
|
| Qualified Health Claim: (QHC) Corn oil and corn oil containing foods and heart disease
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|
|
|
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| EC 1
|
| Institute of Shortening and Edible Oils
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| Vol #:
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| 1
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| 2006P-0245
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| Exclusivity Determination for Risperidone
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| EC 2
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| Mr. David Lowe
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| Vol #:
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| 1
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| EC 3
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| EC 4
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| Mr. David Lowe
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| Vol #:
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| 1
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| EC 5
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| EC 6
|
| Mr. David Lowe
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| Vol #:
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| 1
|
|
|
|
|
| 2006P-0251
|
| Label change or removal from the market of the psychotropic drug Depakote
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|
|
|
|
| EC 1
|
| Mr. D. Lowe
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| Vol #:
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| 1
|
|
|
|
|
| 2006P-0258
|
| Immediately approve ANDA No. 77-837 upon the June 23, 2006 patent expiration of U.S. Patent No. 4,444,784
|
|
|
|
|
| EC 1
|
| Mr. Dave Lowe
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| Vol #:
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| 1
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|
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|
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| EC 2
|
| Mr. D Lowe
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| Vol #:
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| 1
|
|
|
|
|
| 2006P-0271
|
| Amend practice of assessing the performance of medical devices for determining in vitro susceptibility of bacteria or fungi to included CLSI.
|
|
|
|
|
| ACK 1
|
| FDA/DDM to Clinical and Laboratory Standards Institute
|
| Vol #:
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| 1
|
|
|
|
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| CP 1
|
| Clinical and Laboratory Standards Institute
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| Vol #:
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| 1
|
|
|
|
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| 2006V-0269
|
| Laser Light Show
|
|
|
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| ACK 1
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| FDA/ DDM to Saginaw Spirit
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| Vol #:
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| 1
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|
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|
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| VAR 1
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| Saginaw Spirit
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| Vol #:
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| 1
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| 2006V-0270
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| Laser Light Show
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|
|
|
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| ACK 1
|
| FDA/ DDM to Rocky Mount Children's Museum
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| Vol #:
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| 1
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| VAR 1
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| Rocky Mount Children's Museum
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| Vol #:
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| 1
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|
