| | | | | |
|
|
|
|
| Dockets Entered
On August 30, 2007
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| 1998D-0307
|
| Exports/Imports under FDA export reform/enhancement Act 1996
|
|
|
|
|
| 1998D-1232
|
| Points to Consider Guidance Documents on Assayed & Unassayed Quality Control Material
|
|
|
|
|
| 1998N-0359
|
| Program priorities/Center for Food Safety & Applied Nutrition
|
|
|
|
|
| 1999D-1651
|
| Chemistry,Mfging/Control Changes to an approved NADA/ANADA
|
|
|
|
|
| 2003D-0044
|
| Reporting Results for Studies Evaluating Diagnostic Tests
|
|
|
|
|
| 2004D-0333
|
| Emergency Use Authorization of Medical Products
|
|
|
|
|
| 2004N-0226
|
| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
|
|
|
|
|
| 2005D-0112
|
| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
|
|
|
|
|
| 2006D-0020
|
| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device
|
|
|
|
|
| 2006D-0083
|
| Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
|
|
|
|
|
| 2006D-0088
|
| Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
|
|
|
|
|
| 2006D-0108
|
| Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
|
|
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
|
|
| 2006F-0225
|
| 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
|
|
|
|
|
| 2006N-0454
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
|
|
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
|
|
| 2006P-0522
|
| Apply Bioequivalence Requirements Consistent with 21 CFR 320.24(b)(4) to any ANDA for a Generic Drug Product using Lidoderm as its RLD
|
|
|
|
|
| 2007D-0125
|
| Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
|
|
|
|
|
| 2007D-0168
|
| Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
|
|
|
|
|
| 2007D-0169
|
| Guidance for Industry Bioequivalence Recommendations for Specific Products
|
|
|
|
|
| 2007D-0206
|
| Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices
|
|
|
|
|
| 2007D-0233
|
| Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
|
|
|
|
|
| 2007D-0265
|
| Global Harmonization Task Force, Study Groups 1, and 5; New Proposed and Final Documents
|
|
|
|
|
| 2007D-0268
|
| 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
|
|
|
|
|
|
| 2007N-0041
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1998 Categorization
|
|
|
|
|
| 2007N-0231
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-market Approval of Medical Devices
|
|
|
|
|
| 2007N-0277
|
| Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
|
|
|
|
|
| 2007P-0070
|
| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
|
|
|
|
|
| 2007P-0079
|
| To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
|
|
|
|
|
| 2007P-0085
|
| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
|
|
|
|
|
| 2007P-0250
|
| Enact stricter guidelines in prescribing methadone for any reason
|
|
|
|
|
| 2007P-0251
|
| 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
|
|
|
|
|
|
| 2007P-0282
|
| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
|
|
|
|
|
| 2007P-0297
|
| Request to reconsider the failure to approve Provenge
|
|
|
|
|
| 2007P-0316
|
| Risperdal (Risperidone) Tablets
|
|
| | | | | | | | |
|
| |
|
| EC 409
|
| Council for Responsible Nutrition
|
| Vol #:
|
| 12
|
|
|
|
|
| 1999D-1651
|
| Chemistry,Mfging/Control Changes to an approved NADA/ANADA
|
|
|
|
|
| EC 1
|
| Mr. Adam Fogarty
|
| Vol #:
|
| 1
|
|
| |
|
| 2003D-0044
|
| Reporting Results for Studies Evaluating Diagnostic Tests
|
|
|
|
|
| EC 8
|
| UNC Chapel Hill
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0333
|
| Emergency Use Authorization of Medical Products
|
|
|
|
|
| EC 4
|
| Mr. Adam Fogarty
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0226
|
| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
|
|
|
|
|
| EC 32
|
| Mr. Adam Fogarty
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0112
|
| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
|
|
|
|
|
| EC 45
|
| Mr. Adam Fogarty
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0020
|
| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device
|
|
|
|
|
| EC 1
|
| Mr. Adam Fogarty
|
| Vol #:
|
| 2
|
|
|
|
|
| 2006D-0083
|
| Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
|
|
|
|
|
| EC 4
|
| Mr. Adam Fogarty
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0088
|
| Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
|
|
|
|
|
| EC 8
|
| Mr. Adam Fogarty
|
| Vol #:
|
| 3
|
|
| |
|
| 2006D-0108
|
| Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
|
|
|
|
|
| EC 5
|
| Mr. Adam Fogarty
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
|
|
| CR 1
|
| Personalized Medicine Coalition
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 106
|
| AstraZeneca LP
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 107
|
| Cepheid
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 108
|
| Claire Altman Heine Foundation, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 109
|
| Genetic Alliance
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 110
|
| CardioDx
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 111
|
| Genomic Health, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 112
|
| Target Discovery, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 113
|
| Washington Legal Foundation
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 114
|
| Genzyme Corp.
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 115
|
| Advanced Medical Technology Association
|
| Vol #:
|
| 3
|
|
| | | | | | | | |
|
| |
|
| EC 3
|
| ViroPharma Incorporated
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 4
|
| Johnson and Johnson PRD
|
| Vol #:
|
| 1
|
|
| |
|
| 2007D-0169
|
| Guidance for Industry Bioequivalence Recommendations for Specific Products
|
|
|
|
|
| EC 1
|
| UCB, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 2
|
| ViroPharma Incorporated
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 3
|
| Whiteford, Taylor
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007D-0206
|
| Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices
|
|
|
|
|
| EC 3
|
| Mr. Adam Fogarty
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007D-0233
|
| Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
|
|
|
|
|
| EC 1
|
| AstraZeneca LP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007D-0265
|
| Global Harmonization Task Force, Study Groups 1, and 5; New Proposed and Final Documents
|
|
|
|
|
| EC 1
|
| Mrs. Kathy Bates
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 2
|
| Mr. Adam Fogarty
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007D-0268
|
| 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
|
|
|
|
|
|
| |
|
|
|
| EC 4
|
| God's kingdom
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 5
|
| Mr. Adam Fogarty
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 6
|
| Mr. Rodney Jones
|
| Vol #:
|
| 1
|
|
| |
|
| 2007N-0041
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1998 Categorization
|
|
|
|
|
|
|
|
|
|
|
| NCR 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0231
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-market Approval of Medical Devices
|
|
|
|
|
| EC 1
|
| Advanced Medical Technology Association
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0277
|
| Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
| |
|
|
|
| EC 5
|
| Ms. Ruth Fink-Winter
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0070
|
| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
|
|
|
|
|
| EC 52
|
| Mrs. Katie Paredes
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 53
|
| Mr. Adam Fogarty
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 54
|
| Ms. Lauren Raece
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0079
|
| To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
|
|
|
|
|
| EC 4
|
| Mr. Adam Fogarty
|
| Vol #:
|
| 1
|
|
