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| Dockets Entered
On September 20, 2004
Table of Contents
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| Docket #
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| Title
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| 1994P-0018
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| Amend Regulations regarding Homeopathic Drugs
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| 2004N-0018
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| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004N-0181
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| Critical Path Initiative
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| 2004N-0275
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| Agency Emergency Processing Under OMB Review; Application for Participation in the Medical Device Fellowship Program; Form FDA 3608
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| 2004N-0395
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program
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| 2004P-0059
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| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
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| 2004P-0060
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| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
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| 2004P-0074
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| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
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| 2004P-0139
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| approval of generic versions of Concerta (methylphenidate HCI extended-release tablets are both bioequivalent and clinically equivalent to the innovator product
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| 2004P-0141
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| NDA 19-443 Sodium Bicarbonate Injection in PET Abboject Vials was not withdrawn for safety or effectiveness reasons
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| 2004P-0429
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| Authority delegated by the Secretary of Health and Human Services to issue all regulations of the Food and Drug Administration (FDA), to revoke 21C.F.R. Part 11
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| 1994P-0018
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| Amend Regulations regarding Homeopathic Drugs
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| LET
2
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| American Assn of Homeopathic Pharmacists
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| Vol #:
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| 1
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| SUP
29
VCU
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| Northfield Laboratories Inc BB IND 10719
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| Vol #:
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| 29
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7452
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| J. Fetell, M.D. C.C.N.
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| Vol #:
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| 319
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| CS
9
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| HFA-305
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| Vol #:
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| 4
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| OR
8
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| HF-3
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| Vol #:
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| 4
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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| C 24
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| L. DiBattista
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| Vol #:
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| 2
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| 2004N-0018
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| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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| C
7
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| AIDS Vaccine Advocacy Coalition (AVAC)
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| Vol #:
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| 1
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| C
8
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| Bristol-Myers Squibb Company (BMS)
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| Vol #:
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| 1
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| C 7
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| M. Gleason
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| Vol #:
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| 8
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| C 8
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| J. Morrell
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| Vol #:
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| 1
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| C 9
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| M. Wentzel
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| Vol #:
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| 8
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| C 10
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| L.S. Baumann
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| Vol #:
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| 8
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| C 11
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| L. Hecklinger
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| Vol #:
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| 8
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| C 12
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| S. Shapiro, CPA
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| Vol #:
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| 8
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| C 13
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| B. Schmitz
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| Vol #:
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| 8
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| C 14
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| P. Thandi
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| Vol #:
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| 8
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| 2004N-0181
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| Critical Path Initiative
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| C
61
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| Genomas
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| Vol #:
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| 3
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| C
62
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| Komodo Pharmaceutical Services, INc.
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| Vol #:
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| 3
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| C
10
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| Herbalife International, Inc. (Herbalife)
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| Vol #:
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| 4
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| 2004N-0275
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| Agency Emergency Processing Under OMB Review; Application for Participation in the Medical Device Fellowship Program; Form FDA 3608
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2004N-0395
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004P-0059
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| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
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| LET
9
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| Emord & Associates, P.C.
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| Vol #:
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| 13
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| SUP
9
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| Emord & Associates, P.C.
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| Vol #:
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| 13
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| 2004P-0060
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| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
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| LET
9
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| Rotta Pharmaceuticals Inc. (Rotta)
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| Vol #:
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| 3
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| LET
10
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| Rotta Pharmaceuticals Inc. (Rotta)
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| Vol #:
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| 3
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| 2004P-0074
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| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
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| SUP
1
Attachment
1, 2
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| Buchanan Ingersoll
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| Vol #:
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| 1
|
|
|
|
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| 2004P-0139
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| approval of generic versions of Concerta (methylphenidate HCI extended-release tablets are both bioequivalent and clinically equivalent to the innovator product
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| SUP
1
Reference
List
References
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| McNeil Consumer & Specialty Pharmaceuticals
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| Vol #:
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| 5
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| SUP
2
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| McNeil Consumer & Specialty Pharmaceuticals
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| Vol #:
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| 6
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| 2004P-0141
|
| NDA 19-443 Sodium Bicarbonate Injection in PET Abboject Vials was not withdrawn for safety or effectiveness reasons
|
|
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| LET
1
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| HFD-005 to Abbott Laboratories
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| Vol #:
|
| 1
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