| | | | | | | | | | |
|
|
| Dockets Entered
On September 16, 2003
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1984F-0095
|
| SAFE USE OF POLYAMINE-EPICHLOROHYDRIN RESIN IN CORN SYRUP
|
|
|
| 1990S-0308
|
| Generic Drug Speeches & Policy and Procedure Guides
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| 2002D-0094
|
| IND Exemptions for Studies of Lawfully Marketed Cancer Drugs
|
|
|
| 2002N-0486
|
| Prescription Drug Marketing Act of 1987
|
|
|
| 2003D-0186
|
| Guidance for Industry: Use of Material From Deer and Elk In Animal Feed
|
|
|
| 2003D-0399
|
| Guidance: Pentetate Calcium Trisodium and Pentetate Zinc Trisodium for Treatment of Internal Contamination with Plutonium, Americium, or Curium
|
|
|
| 2003D-0412
|
| International Conference on Harmonisation; Draft Guidance on E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting
|
|
|
| 2003M-0086
|
| Carpentier-Edwards S.A.V. Bioprosthesis Model 1650 (Aortic)
|
|
|
| 2003M-0427
|
| P020025 - EP Technologies EPT-1000 XPb
|
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
|
|
| 2003N-0397
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Extension; Threshold of Regulation for Substances used in Food-Contact Articles
|
|
|
| 2003V-0433
|
| Laser Light Show
|
|
|
| 1984F-0095
|
| SAFE USE OF POLYAMINE-EPICHLOROHYDRIN RESIN IN CORN SYRUP
|
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 1990S-0308
|
| Generic Drug Speeches & Policy and Procedure Guides
|
|
|
| M
734
|
| Statistical Report for June 2003
|
| Vol #:
|
| 52
|
|
|
| M
735
|
| Statistical Report for July 2003
|
| Vol #:
|
| 52
|
|
|
| M
736
|
| Statistical Report for August 2003
|
| Vol #:
|
| 52
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| LET
10931
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10932
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10933
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10934
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10935
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10936
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10937
|
| Tradeworks Group, Inc.
|
| Vol #:
|
| 83
|
|
|
| LET
10938
|
| Iowa State University Research Park
|
| Vol #:
|
| 83
|
|
|
| LET
10939
|
| O Premium Waters
|
| Vol #:
|
| 83
|
|
|
| LET
10940
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10941
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10942
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10943
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10944
|
| PhytoPharmica Nautral Medicines
|
| Vol #:
|
| 83
|
|
| | | | | | | |
|
|
| LET
10945
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10946
|
| Gaia Herbs
|
| Vol #:
|
| 83
|
|
|
| LET
10947
|
| Source Naturals
|
| Vol #:
|
| 83
|
|
|
| LET
10948
|
| Source Naturals
|
| Vol #:
|
| 83
|
|
|
| LET
10949
|
| Source Naturals
|
| Vol #:
|
| 83
|
|
|
| LET
10950
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10951
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10952
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 83
|
|
|
| LET
10953
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 832
|
|
|
| LET
10954
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10955
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10956
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10957
|
| Solstice Medicine Company
|
| Vol #:
|
| 83
|
|
|
| LET
10958
|
| Solstice Medicine Company
|
| Vol #:
|
| 83
|
|
|
| LET
10959
|
| Solstice Medicine Company
|
| Vol #:
|
| 83
|
|
|
| LET
10960
|
| Sostice Medicine Company
|
| Vol #:
|
| 83
|
|
|
| LET
10961
|
| Global Chinese Herbs Depot Inc.
|
| Vol #:
|
| 83
|
|
|
| LET
10962
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10963
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10964
|
| Wyeth Consumer Healthcare
|
| Vol #:
|
| 83
|
|
|
| LET
10965
|
| Wyeth Consumer Healthcare
|
| Vol #:
|
| 83
|
|
|
| LET
10966
|
| Wyeth Consumer Healthcare
|
| Vol #:
|
| 83
|
|
|
| LET
10967
|
| Enzymatic Therapy Nautral Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10968
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10969
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10970
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10971
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10972
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10973
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10974
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10975
|
| Herb Pharm
|
| Vol #:
|
| 83
|
|
|
| LET
10976
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10977
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10978
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10979
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10980
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10981
|
| Dee Cee laboratories, Inc.
|
| Vol #:
|
| 83
|
|
| | | | | | | | |
|
|
| LET
10982
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 83
|
|
|
| LET
10983
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10984
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10985
|
| Nutra Therapeutics
|
| Vol #:
|
| 83
|
|
|
| LET
10986
|
| DMD Pharmaceuticals
|
| Vol #:
|
| 83
|
|
|
| LET
10987
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 83
|
|
|
| LET
10988
|
| Chattem, Inc.
|
| Vol #:
|
| 83
|
|
|
| LET
10989
|
| Flora
|
| Vol #:
|
| 83
|
|
|
| LET
10990
|
| Flora
|
| Vol #:
|
| 83
|
|
|
| 2002D-0094
|
| IND Exemptions for Studies of Lawfully Marketed Cancer Drugs
|
|
|
| GDL
2
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
| 2002N-0486
|
| Prescription Drug Marketing Act of 1987
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003D-0186
|
| Guidance for Industry: Use of Material From Deer and Elk In Animal Feed
|
|
|
| GDL
2
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003D-0399
|
| Guidance: Pentetate Calcium Trisodium and Pentetate Zinc Trisodium for Treatment of Internal Contamination with Plutonium, Americium, or Curium
|
|
|
| BKG
1
Tab
1-72
|
| Background Material
|
| Vol #:
|
| 2
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003D-0412
|
| International Conference on Harmonisation; Draft Guidance on E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
| 2003M-0086
|
| Carpentier-Edwards S.A.V. Bioprosthesis Model 1650 (Aortic)
|
|
|
| CR
1
|
| HFZ-402
|
| Vol #:
|
| 1
|
|
|
| 2003M-0427
|
| P020025 - EP Technologies EPT-1000 XPb
|
|
|
| AAV
1
|
| Boston Scientific Corporation
|
| Vol #:
|
| 1
|
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
|
|
| APE 11
|
| EPCglobal US
|
| Vol #:
|
| 1
|
|
|
| APE 12
|
| SCA Ltd
|
| Vol #:
|
| 1
|
|
|
| APE 13
|
| Isotag Technology, Inc
|
| Vol #:
|
| 1
|
|
|
| 2003N-0397
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Extension; Threshold of Regulation for Substances used in Food-Contact Articles
|
|