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| Dockets Entered
On August 30, 2007
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 1998D-0307
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| Exports/Imports under FDA export reform/enhancement Act 1996
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| 1998D-1232
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| Points to Consider Guidance Documents on Assayed & Unassayed Quality Control Material
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutrition
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| 1999D-1651
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| Chemistry,Mfging/Control Changes to an approved NADA/ANADA
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| 2003D-0044
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| Reporting Results for Studies Evaluating Diagnostic Tests
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| 2004D-0333
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| Emergency Use Authorization of Medical Products
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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-0112
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| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
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| 2006D-0020
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| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device
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| 2006D-0083
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| Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
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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-0108
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| Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
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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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| 2006F-0225
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| Safe Use of glycerol ester of tall oil rosin to adjust the density of citrus oils used in preparations of beverages(FAP 6A4765); to amend the food additive regulations in 21 CFR 172.735
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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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-0522
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| Apply Bioequivalence Requirements Consistent with 21 CFR 320.24(b)(4) to any ANDA for a Generic Drug Product using Lidoderm as its RLD
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| 2007D-0125
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| Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
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| 2007D-0168
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| Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
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| 2007D-0169
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| Guidance for Industry Bioequivalence Recommendations for Specific Products
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| 2007D-0206
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| Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices
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| 2007D-0233
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| Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
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| 2007D-0265
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| Global Harmonization Task Force, Study Groups 1, and 5; New Proposed and Final Documents
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| 2007D-0268
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
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| 2007N-0041
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1998 Categorization
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| 2007N-0231
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-market Approval of Medical Devices
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| 2007N-0277
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| Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
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| 2007P-0070
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| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
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| 2007P-0079
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| To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| 2007P-0250
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| Enact stricter guidelines in prescribing methadone for any reason
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| 2007P-0251
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| Petition for a policy statement requiring that all future advisory committee meetings discussing specific products include an oral scientific presentation by FDA staff on the products reviewed, includ
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| 2007P-0282
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| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
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| 2007P-0297
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| Request to reconsider the failure to approve Provenge
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| 2007P-0316
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| Risperdal (Risperidone) Tablets
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| EC 409
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| Council for Responsible Nutrition
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| Vol #:
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| 12
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| 1999D-1651
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| Chemistry,Mfging/Control Changes to an approved NADA/ANADA
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| EC 1
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| Mr. Adam Fogarty
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| Vol #:
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| 1
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| 2003D-0044
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| Reporting Results for Studies Evaluating Diagnostic Tests
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| EC 8
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| UNC Chapel Hill
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| Vol #:
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| 1
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| 2004D-0333
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| Emergency Use Authorization of Medical Products
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| EC 4
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| Mr. Adam Fogarty
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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 32
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| Mr. Adam Fogarty
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| Vol #:
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| 1
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| 2005D-0112
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| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
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| EC 45
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| Mr. Adam Fogarty
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| Vol #:
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| 1
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| 2006D-0020
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| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device
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| EC 1
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| Mr. Adam Fogarty
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| Vol #:
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| 2
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| 2006D-0083
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| Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
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| EC 4
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| Mr. Adam Fogarty
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| Vol #:
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| 1
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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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| EC 8
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| Mr. Adam Fogarty
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| Vol #:
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| 3
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| 2006D-0108
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| Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
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| EC 5
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| Mr. Adam Fogarty
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| Vol #:
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| 1
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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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| CR 1
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| Personalized Medicine Coalition
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| Vol #:
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| 3
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| EC 106
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| AstraZeneca LP
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| Vol #:
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| 3
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| EC 107
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| Cepheid
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| Vol #:
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| 3
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| EC 108
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| Claire Altman Heine Foundation, Inc.
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| Vol #:
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| 3
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| EC 109
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| Genetic Alliance
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| Vol #:
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| 3
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| EC 110
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| CardioDx
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| Vol #:
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| 3
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| EC 111
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| Genomic Health, Inc.
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| Vol #:
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| 3
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| EC 112
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| Target Discovery, Inc.
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| Vol #:
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| 3
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| EC 113
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| Washington Legal Foundation
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| Vol #:
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| 3
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| EC 114
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| Genzyme Corp.
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| Vol #:
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| 3
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| EC 115
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| Advanced Medical Technology Association
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| Vol #:
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| 3
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| EC 3
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| ViroPharma Incorporated
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| Vol #:
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| 1
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| EC 4
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| Johnson and Johnson PRD
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| Vol #:
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| 1
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| 2007D-0169
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| Guidance for Industry Bioequivalence Recommendations for Specific Products
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| EC 1
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| UCB, Inc.
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| Vol #:
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| 1
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| EC 2
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| ViroPharma Incorporated
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| Vol #:
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| 1
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| EC 3
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| Whiteford, Taylor
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| Vol #:
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| 1
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| 2007D-0206
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| Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices
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| EC 3
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| Mr. Adam Fogarty
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| Vol #:
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| 1
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| 2007D-0233
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| Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
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| EC 1
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| AstraZeneca LP
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| Vol #:
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| 1
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| 2007D-0265
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| Global Harmonization Task Force, Study Groups 1, and 5; New Proposed and Final Documents
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| EC 1
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| Mrs. Kathy Bates
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| Vol #:
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| 1
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| EC 2
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| Mr. Adam Fogarty
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| Vol #:
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| 1
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| 2007D-0268
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
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| EC 4
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| God's kingdom
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| Vol #:
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| 1
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| EC 5
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| Mr. Adam Fogarty
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| Vol #:
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| 1
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| EC 6
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| Mr. Rodney Jones
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| Vol #:
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| 1
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| 2007N-0041
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1998 Categorization
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| NCR 1
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| FDA
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| Vol #:
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| 1
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| 2007N-0231
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-market Approval of Medical Devices
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| EC 1
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| Advanced Medical Technology Association
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| Vol #:
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| 1
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| 2007N-0277
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| Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
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| EC 5
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| Ms. Ruth Fink-Winter
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| Vol #:
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| 1
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| 2007P-0070
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| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
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| EC 52
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| Mrs. Katie Paredes
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| Vol #:
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| 1
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| EC 53
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| Mr. Adam Fogarty
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| Vol #:
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| 1
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| EC 54
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| Ms. Lauren Raece
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| Vol #:
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| 1
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| 2007P-0079
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| To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
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| EC 4
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| Mr. Adam Fogarty
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| Vol #:
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| 1
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