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| Dockets Entered
On October 5, 2006
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| Docket #
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| Title
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| 1975N-0183F
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| Topical Antimicrobial Drug Products For OTC Human Use - First Aid
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| 1992N-0461
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| Debarment Gloria Schetlick;Notice of Opportunity for hearing
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| 1993N-0100
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| Debarment of Kumar Prasad; Notice of Opportunity for Hearing
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2001V-0102
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| Laser light show projector
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2004P-0070
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| Withhold approval of any abbreviated New Drug Application ( ANDA) for a generic version of Ferrlecit( sodium ferric gluconate complex in sucrose ) until the conditions set forth in this petition are s
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal 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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| 2006D-0297
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| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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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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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| 2006N-0219
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| Clinical Trial Design Issues in the Development of Products for Treatment of Chronic Hepatitis C Infection
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| 2006N-0292
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| Unique Device Identification
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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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| 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-0165
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| Initiate administrative proceedings for the purpose of investigating and enjoining the unlawful sale and distribution by International Tan Makers, Inc., of ultraviolet suntanning lamps that are misbr
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| 2006P-0306
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| Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone
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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-0397
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| Permit an ANDA Suitability for Fexofenadine Hydrochloride for Oral Suspension
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| 2006P-0406
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| Take appropriate remedial action against the apparent misbranding of generic azithromycin for oral suspension marketed by Pliva, Inc.
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| 1975N-0183F
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| Topical Antimicrobial Drug Products For OTC Human Use - First Aid
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| C 22
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| Alcavis International, Inc. (Aleavis)
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| Vol #:
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| 8
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| C 92
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| Alcavis International, Inc. (Alcavis)
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| Vol #:
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| 200
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| 1992N-0461
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| Debarment Gloria Schetlick;Notice of Opportunity for hearing
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| LET 2
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| FDA/DDM to Federal Prision Camp Alderson
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| Vol #:
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| 1
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| 1993N-0100
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| Debarment of Kumar Prasad; Notice of Opportunity for Hearing
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| LET 2
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| FDA-DDM to Mr. Kumar Prasad
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| Vol #:
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| 1
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 18141
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| LET 18142
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| NDS Nutritional Products Inc
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| Vol #:
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| 167
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| LET 18143
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| NDS Nutritional Products Inc
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| Vol #:
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| 167
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| LET 18144
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| NDS Nutritional Products Inc
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| Vol #:
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| 167
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| LET 18145
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| NDS Nutritional Products Inc
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| Vol #:
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| 167
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| LET 18146
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| NDS Nutritional Products Inc
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| Vol #:
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| 167
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| LET 18147
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| NDS Nutritional Products Inc
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| Vol #:
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| 167
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| LET 18148
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| NDS Nutritional Products Inc
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| Vol #:
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| 167
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| LET 18149
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| Pharmanex, Div. of NSE Products
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| Vol #:
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| 167
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| LET 18150
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| Source naturals
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| Vol #:
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| 167
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| LET 18151
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| Source Naturals
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| Vol #:
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| 167
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| LET 18152
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| LET 18153
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| LET 18154
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| LET 18155
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| LET 18156
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| LET 18157
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| Taian Zhongxin Lingzhi Technology and Development Co Ltd
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| Vol #:
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| 167
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| LET 18158
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| Taian Zhongxin Lingzhi Technology and Development Co Ltd
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| Vol #:
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| 167
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| LET 18159
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| LET 18160
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| LET 18161
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| LET 18162
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| 2001V-0102
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| Laser light show projector
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| EXP 1
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| Nth Degree Creative
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| Vol #:
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| 1
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| EC 32
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| Mr. steve Soderdahl
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| Vol #:
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| 5
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| 2004P-0070
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| Withhold approval of any abbreviated New Drug Application ( ANDA) for a generic version of Ferrlecit( sodium ferric gluconate complex in sucrose ) until the conditions set forth in this petition are s
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| SUP 1
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| Watson Pharma, Inc.
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| Vol #:
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| 1
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| C 1
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| Novartis Pharmaceuticals Corporation
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| Vol #:
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| 3
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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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| C 12
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| Consumer Federation of America (CFA)
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| Vol #:
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| 7
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| 2006D-0297
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| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability
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| C 1
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| Abbott
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| Vol #:
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| 1
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| EC 1
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| Generic Pharmaceutical Association
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| Vol #:
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| 1
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| APE 3
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| T. Schmidt, MD, MS
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| Vol #:
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| 2
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| CR 1
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| University of Texas Southwestern Medical Center and the Parkland Health and Hospital System
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| Vol #:
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| 2
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| LST 1
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| List of Presenters at Part 15 Public Hearing - Conduct of Emergency Clinical Research (10/11/2006)
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| Vol #:
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| 2
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| LST 2
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| List of Panelists at Part 15 Public Hearing - Conduct of Emergency Clinical Research (10/11/2006)
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| Vol #:
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| 2
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| LST 3
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| Agenda for the Conduct of Emergency Clinical Research;Public Hearing held on October 11, 2006
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| Vol #:
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| 2
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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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| EC 2
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| NHIC - CA Medicare Part B Contractor
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| Vol #:
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| 1
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| EC 11
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| Edmonds Institute
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| Vol #:
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| 1
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| EC 12
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| Mr. Thomas Jeanne
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| Vol #:
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| 1
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| 2006N-0219
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| Clinical Trial Design Issues in the Development of Products for Treatment of Chronic Hepatitis C Infection
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| EC 2
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| Hepatitis C Treatment Centers
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| Vol #:
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| 1
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| 2006N-0292
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| Unique Device Identification
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| EC 25
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| Department of Health, Medical Qaulity Assurance Co
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| Vol #:
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| 1
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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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| EC 70
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| Mr. Ken Allan
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| Vol #:
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| 3
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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 729
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| Mrs. Virginia Linman
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| Vol #:
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| 3
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| EC 730
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| Ms. Kate E. Robinson
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| Vol #:
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| 3
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| EC 731
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| Toxic Discovery
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| Vol #:
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| 3
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| EC 732
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| Mrs. Theresa LaRock
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| Vol #:
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| 3
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| EC 733
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| Mrs. Carolyn Wolf
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| Vol #:
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| 3
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| EC 734
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| Ms. Kay Bowers
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| Vol #:
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| 3
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| EC 735
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| Ms. Laura Howell (Baeza)
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| Vol #:
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| 3
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| 2006P-0165
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| Initiate administrative proceedings for the purpose of investigating and enjoining the unlawful sale and distribution by International Tan Makers, Inc., of ultraviolet suntanning lamps that are misbr
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| LET 1
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| FDA/CDRH to Banner & Witcoff, Ltd.
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| Vol #:
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| 1
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| 2006P-0306
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| Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone
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