Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870; TTY/TDD Users 1-800-735-2258 - [E-mail Us] DOCKETS ENTERED on October 11, 2002 TABLE OF CONTENTS Hyper links are part of the Docket title - not all dockets/documents are linked NOTE: Documents received by the Dockets Management Branch "MAY" be posted on the Internet. PLEASE DO NOT include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence. |
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77N-094I Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro
EXT 1 Wyeth Consumer Healthcare Vol#: 1
86P-0297 Standards of Identity to Amend Certain Chocolate Products
NFR 2 Vol#: 3
93P-0091 Amend Standard Identity Cacao Products re: White Chocolate
NFR 1 Vol#: 1
98P-0151 Introduction Of Downed Cattle Into The Food Supply
C 5925 Mr. Booth K. Bender Vol#: 251
00D-1538 Electronic Records; Electronic Signatures, Validation
MM 28 HFC-240 & IntraLinks, Inc. & SEC Associa Vol#: 7
MM 29 HFC-240 & Daon, Co. (Met 08/07/02) Vol#: 7
MM 30 HFC-240 & IMAGe-X, Inc. (Met 07/25/02) Vol#: 7
MM 31 HFC-240 & Agile Software Inc Met 8/28/02 Vol#: 7
00D-1539 Electronic Records & Signatures, Retention of Electronic Rec
MM 28 HFC-240 & IntraLinks, Inc. & SEC Associa Vol#: 6
MM 29 HFC-240 & Daon, Co. (Met 08/07/02) Vol#: 6
MM 30 HFC-240 & IMAGe-X, Inc. (Met 07/25/02) Vol#: 6
MM 31 HFC-240 & Agile Software Inc Met 8/28/02 Vol#: 6
00D-1540 Electronic Signatures, Electronic Copies of Electronic Recor
MM 28 HFC-240 & IntraLinks, Inc. & SEC Associa Vol#: 6
MM 29 HFC-240 & Daon, Co. (Met 08/07/02) Vol#: 6
MM 30 HFC-240 & IMAGe-X, Inc. (Met 07/25/02) Vol#: 6
MM 31 HFC-240 & Agile Software Inc Met 8/28/02 Vol#: 6
00D-1541 Electronic Signatures: Audit Trails
MM 29 HFC-240 & IntraLinks, Inc. & SEC Associa Vol#: 6
MM 30 HFC-240 & Daon, Co. (Met 08/07/02) Vol#: 6
MM 31 HFC-240 & IMAGe-X, Inc. (Met 07/25/02) Vol#: 6
MM 32 HFC-240 & Agile Software Inc Met 8/28/02 Vol#: 6
00D-1542 Electronic Signatures: Time Stamps
MM 28 HFC-240 & IntraLinks, Inc. & SEC Associa Vol#: 6
MM 29 HFC-240 & Daon, Co. (Met 08/07/02) Vol#: 6
MM 30 HFC-240 & IMAGe-X, Inc. (Met 07/25/02) Vol#: 6
MM 31 HFC-240 & Agile Software Inc Met 8/28/02 Vol#: 6
00D-1543 Electronic Signatures: Glossary of Terms
MM 28 HFC-240 & IntraLinks, Inc. & SEC Associa Vol#: 7
MM 29 HFC-240 & Daon, Co. (Met 08/07/02) Vol#: 7
MM 30 HFC-240 & IMAGe-X, Inc. (Met 07/25/02) Vol#: 7
MM 31 HFC-240 & Agile Software Inc Met 8/28/02 Vol#: 7
01D-0202 Provisions of the FDA Modernization Act of 1997
GDL 2 GUIDANCE Vol#: 1
NAD 2 Vol#: 1
01D-0493 Exemptions from the Warning Label Requirement for Juice;Reco
GDL 2 Guidance for Industry Vol#: 1
NAD 2 Guidance for Industry Vol#: 1
01P-0396 Request that FDA ban the production and sale of all ephedra
EMC 8 Kathleen Ann Zimmerman Vol#: 1
EMC 9 Mike Carroll Vol#: 1
02D-0384 Standardized Training Curriculum for Application of HACCP
GDL 1 Guidance for Industry Vol#: 1
NAD 1 Guidance for Industry Vol#: 1
02N-0062 New Dietary Ingredient Premarket Notification,Info. Collect
NAL 1 Vol#: 1
SS 1 SUPPORTING STATEMENT Vol#: 1
02N-0112 Regulations Under the Federal Import Milk Act
NAL 1 Vol#: 1
SS 1 SUPPORTING STATEMENT Vol#: 1
02N-0204 Bar Code Label Requirements for human drug products
APE 114 American Medical Assn Vol#: 7
APE 115 Dave Collins Vol#: 7
02N-0209 Governing First Amendment Case Law
02N-0275 Bioterrorism Preparedness; Administrative Detention
EMC 10 NASFT, Nat. Assn for the Specialty Food Vol#: 3
02N-0276 Bioterrorism Preparedness;Registration of Food Facilities
EMC 12 NASFT, Nat. Assn for the Specialty Food Vol#: 3
02N-0277 Bioterrorism; Establishment & Maintenance of Records
EMC 10 NASFT, Nat. Assn for the Specialty Food Vol#: 3
02N-0278 Bioterrorism;Prior Notice of Imported Food Shipments
EMC 11 NASFT, Nat. Assn for the Specialty Food Vol#: 3
02P-0009 Amend 21 CFR 120.24 concentrated and shelf-stable juice
GDL 1 Guidance for Industry Vol#: 1
NAD 1 Guidance for Industry Vol#: 1
02P-0246 Pharmacies of hospitals/other health care entities
LET 2 University of Colorado Hospital Vol#: 1
02P-0444 cefpodoxime Proxetil talbets for Oral suspension 50mg/100mg