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Dockets Management
Dockets Entered On March 29, 2005
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1999P-5332 Amend limit Hydrogenated & partially Hydrogenated Menhaden O
2003D-0497 Guidance for Industry on Pharmacogenomic Data Submissions
2003F-0088 Increase the Maximum Permitted Energy Level of X-rays
2004P-0285 To determine whether Aciphex (rabeprazole sodium) delayed-release tablets, 10mg (NDA 20-973) has been voluntarily withdrawn or withheld from sale for safety or effectiveness reasons
2005D-0082 Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems; Availability
2005D-0103 Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
2005N-0081 Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems
2005N-0098 Food and Drug Administration/Drug Information Association Cross Labeling Workshop: Combination Products and Mutually Conforming Labeling
2005N-0100 Agency Information Collection Activities; Proposed Collection; Comment Request; CGMP Regulations for Finished Pharmaceuticals
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 15769 RAND Research Laboratories TM, LLC Vol #: 139
LET 15770 Hillestad Pharmaceuticals Vol #: 139
LET 15771 Food Science Corporation Vol #: 139
LET 15772 Food Science Corporation Vol #: 139
LET 15773 Hillestad Pharmaceuticals Vol #: 139
LET 15774 Hillestad Pharmaceuticals Vol #: 139
LET 15775 Hillestad Pharmaceuticals Vol #: 139
LET 15776 Herbalife International of America, Inc. Vol #: 139
LET 15777 Hillestad Pharmaceuticals Vol #: 139
LET 15778 Hillestad Pharmaceuticals Vol #: 139
LET 15779 Tomil Herb Inc. Vol #: 139
LET 15780 Tomil Herb Inc. Vol #: 139
LET 15781 Tomil Herb Inc. Vol #: 139
LET 15782 Tomil Herb Inc. Vol #: 139
LET 15783 Tomil Herb Inc. Vol #: 139
LET 15784 Tomil Herb Inc. Vol #: 139
LET 15785 Tomil Herb Inc. Vol #: 139
LET 15786 Tomil Herb Inc. Vol #: 139
LET 15787 Tomil Herb Inc. Vol #: 139
LET 15788 Tomil Herb Inc. Vol #: 139
LET 15789 CNS, Inc. Vol #: 139
LET 15790 Arise & Shine Herbal Products, Inc. Vol #: 139
LET 15791 Advocare International, L.P. Vol #: 139
LET 15792 Patent Health, LLC Vol #: 139
LET 15793 Enzymatic Therapy Vol #: 139
LET 15794 Enzymatic Therapy Vol #: 139
LET 15795 Enzymatic Therapy Vol #: 139
LET 15796 Enzymatic Therapy Vol #: 139
LET 15797 Enzymatic Therapy Vol #: 139
LET 15798 Enzymatic Therapy Vol #: 139
LET 15799 Enzymatic Therapy Vol #: 139
LET 15800 Enzymatic Therapy Vol #: 139
LET 15801 Enzymatic Therapy Vol #: 139
LET 15802 Enzymatic Therapy Vol #: 139
LET 15803 Enzymatic Therapy Vol #: 139
LET 15804 Enzymatic Therapy Vol #: 139
LET 15805 Enzymatic Therapy Vol #: 139
LET 15806 Enzymatic Therapy Vol #: 139
LET 15807 Enzymatic Therapy Vol #: 139
1999P-5332 Amend limit Hydrogenated & partially Hydrogenated Menhaden O
NFR 1 FDA Vol #: 1
2003D-0497 Guidance for Industry on Pharmacogenomic Data Submissions
GDL 2
Attachment 		Guidance Vol #: 2
NAD 2 FDA Vol #: 2
2003F-0088 Increase the Maximum Permitted Energy Level of X-rays
NCR 1 FDA Vol #: 1
2004P-0285 To determine whether Aciphex (rabeprazole sodium) delayed-release tablets, 10mg (NDA 20-973) has been voluntarily withdrawn or withheld from sale for safety or effectiveness reasons
N 1 FDA Vol #: 1
2005D-0082 Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems; Availability
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2005D-0103 Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
LET 1 Council for International Organizations of Medical Sciences (CIOMS) Vol #: 2
LST 2 Final List of Speakers for March 21, 2005 Hearing Vol #: 2
LST 3 List of Panel Members for March 21, 2005 Hearing Vol #: 2
TS 2 University of Pennsylvania Vol #: 2
TS 3 Yale University School of Medicine IRB Vol #: 2
TS 4 IRB-Sponsor Roundtable Vol #: 2
TS 5 University of Rochester Vol #: 2
TS 6 Western Institutional Review Board Vol #: 2
TS 7 Western Institutional Review Board (WIRB) Vol #: 2
TS 8 Associatoin of American Medical Colleges Vol #: 2
TS 9 PPD, Association of Clinical Research Organizations (ACRO) Vol #: 2
2005N-0081 Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems
NFR 1 FDA Vol #: 1
2005N-0098 Food and Drug Administration/Drug Information Association Cross Labeling Workshop: Combination Products and Mutually Conforming Labeling
NM 1 FDA Vol #: 1
2005N-0100 Agency Information Collection Activities; Proposed Collection; Comment Request; CGMP Regulations for Finished Pharmaceuticals
N 1 FDA Vol #: 1

Page created on April 5, 2005 dp

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