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| Dockets Entered
On October 11, 2006
Table of Contents
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| Docket #
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| Title
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| 1981P-0001
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| Laser Lumia Projection System
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| 2004E-0444
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| Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814
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| 2004N-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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| 2005D-0047
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| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2006D-0296
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| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Annex on Residue on Ignition/Sulphated Ash General Chapter;
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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| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability
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| 2006N-0312
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| Preparation for International Conference on Harmonization Meetings in Chicago, Illinois; Public Meeting
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| 2006P-0154
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| remove from the market, the prescription version of Xenical (orlistat,Roche Pharmaceuticals)
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| 2006P-0160
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| Change Daranide Tablets, 50 mg to a generic version
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| 2006P-0307
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| To amend 21CFR 201.17 regarding expiration dates
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| 2006P-0398
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| Require bioequivalence studies for generic or follow-on formulations of MEGACE ES (megestrol acetate oral suspension 625 mg/5 ml)
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| 2006P-0410
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| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
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| 2006Q-0091
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| Qualified Health Claim (QHC): Unsaturated Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease
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| 1981P-0001
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| Laser Lumia Projection System
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| VRA 14
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| FDA/CDRH to Lighting Systems Design Inc
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| 1
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| 2004E-0444
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| Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814
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| NCR 1
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| FDA
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| 1
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| 2004N-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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| BKG 2
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| Background information for NFR1
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| 4
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| NFR 1
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| FDA
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| 3
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| 2005D-0047
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| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
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| C 7
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| Scarab Genomics LLC
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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 9
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| FDA/CDRH
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| 6
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| 2006D-0296
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| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Annex on Residue on Ignition/Sulphated Ash General Chapter;
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| C 2
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| Sanofi-Synthelabo Inc and Aventis Pharmaceuticals
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| 1
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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 3
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| Sanofi-Synthelabo Inc and Aventis Pharmaceuticals
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| 1
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| 2006N-0312
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| Preparation for International Conference on Harmonization Meetings in Chicago, Illinois; Public Meeting
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| TS 1
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| FDA/CDER
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| Vol #:
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| 1
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| TS 2
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| R Wise, A Feight
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| 1
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| TS 3
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| FDA/CDER
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| 1
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| TS 4
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| FDA/CDER
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| 1
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| TS 5
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| FDA/CDER
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| 1
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| TS 6
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| FDA/CDER
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| 1
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| 2006P-0154
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| remove from the market, the prescription version of Xenical (orlistat,Roche Pharmaceuticals)
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| LET 1
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| FDA/CDER to Public Citizen Health Research Group
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| 1
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| 2006P-0160
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| Change Daranide Tablets, 50 mg to a generic version
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| LET 1
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| FDA/CDER to Taro Research Institute
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| 1
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| 2006P-0307
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| To amend 21CFR 201.17 regarding expiration dates
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| SUP 1
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| S Lohiya
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| Vol #:
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| 1
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| 2006P-0398
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| Require bioequivalence studies for generic or follow-on formulations of MEGACE ES (megestrol acetate oral suspension 625 mg/5 ml)
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| C 1
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| D Lowe
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| 1
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| 2006P-0410
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| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
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| ACK 1
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| FDA/DDM to MedImmune Oncology, Inc.
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| Vol #:
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| 1
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| CP 1
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| MedImmune Oncology, Inc.
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| Vol #:
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| 1
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| 2006Q-0091
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| Qualified Health Claim (QHC): Unsaturated Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease
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| PAV 1
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| FDA/CFSAN to Johnson Nutrition SOlutions LLC
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| Vol #:
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| 6
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