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| Dockets Entered
On December 3, 2003
Table of Contents
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| Docket #
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| Title
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| 2003D-0204
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| Guidance for Industry: IRB Review of Stand-Alone HIPAA Authorizations; Availability
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| 2003D-0383
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| Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability
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| 2003D-0385
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| Guidance for Industry: Comparability Protocols b
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| 2003D-0391
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Precious Metal Alloys and Class II Special Controls Guidance Document: Dental Base Metal Alloys
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2003E-0246
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| Patent Extension for Deramaxx (deracoxib), 5,521,207,
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| 2003F-0535
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| Filing of Food Additive Petition (FAP 4A4751) Chlorine dioxide
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0194
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| Agency Information Collection Activities: Proposed Collection: Comment Request; Agreement for Shipment of Devices for Sterilization
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| 2003N-0200
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Export of Medical Devices; Foreign Letters of Approval
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| 2003N-0308
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| CIVIL MONEY PENALTIES HEARINGS; MAXIMUM PENALTY AMOUNTS AND Compliance with the FEDERAL CIVIL PENALTIES Inflation Adjustment Act
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| 2003N-0344
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| Consumer-Directed Promotion; Public Meeting
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| 2003N-0390
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| Dental Devices; Gold Based Alloys, Precious Metal Alloys, and Base Metal Alloys; Designation of Special Controls
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| 2003P-0321
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| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| ACK
5
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| HFA-305
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| Vol #:
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| 6
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| PSA
4
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| Pharmaceutical Distributors Association
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| Vol #:
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| 6
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| ACK
6
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| HFA-305
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| Vol #:
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| 8
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| PSA
4
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| Pharmaceutical Distributors Association
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| Vol #:
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| 8
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| 2003D-0204
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| Guidance for Industry: IRB Review of Stand-Alone HIPAA Authorizations; Availability
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| EMC
1
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| American Association of Blood Banks
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| Vol #:
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| 1
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| 2003D-0383
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| Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability
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| C
4
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| Abbott Laboratories
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| Vol #:
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| 1
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| 2003D-0385
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| Guidance for Industry: Comparability Protocols b
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| C
2
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| Aventis Pharmaceuticals, Inc
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| Vol #:
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| 1
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| 2003D-0391
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Precious Metal Alloys and Class II Special Controls Guidance Document: Dental Base Metal Alloys
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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| GDL
2
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| Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| C 4
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| M Rincon
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| Vol #:
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| 1
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| C 5
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| M E Powell
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| Vol #:
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| 1
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| C 6
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| K A Williams
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| Vol #:
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| 1
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| EMC 13
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| D L Psencik
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| Vol #:
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| 1
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| EMC 14
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| A Raney
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| Vol #:
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| 1
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| 2003E-0246
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| Patent Extension for Deramaxx (deracoxib), 5,521,207,
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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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| 2003F-0535
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| Filing of Food Additive Petition (FAP 4A4751) Chlorine dioxide
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| EA
1
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| Vulcan Chemicals
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| Vol #:
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| 1
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| NFL
1
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| FDA
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| Vol #:
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| 1
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 106
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| G Derick
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| Vol #:
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| 3
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| EMC 107
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| D McDonald BSE
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| Vol #:
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| 3
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| EMC 108
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| George, Carol etc.
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| Vol #:
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| 3
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| 2003N-0194
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| Agency Information Collection Activities: Proposed Collection: Comment Request; Agreement for Shipment of Devices for Sterilization
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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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| 2003N-0200
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Export of Medical Devices; Foreign Letters of Approval
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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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| 2003N-0308
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| CIVIL MONEY PENALTIES HEARINGS; MAXIMUM PENALTY AMOUNTS AND Compliance with the FEDERAL CIVIL PENALTIES Inflation Adjustment Act
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| NPR
1
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| FDA
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| Vol #:
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| 1
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| 2003N-0344
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| Consumer-Directed Promotion; Public Meeting
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| EMC
15
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| K Altar, RN, BSN, S Clark, RN, BSN, Y Exeter RN BSN, J Stank RN BSN
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| Vol #:
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| 2
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| EMC
16
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| Academy of Managed Care Pharmacy
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| Vol #:
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| 2
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| EMC
17
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| Harvard Business School
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| Vol #:
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| 2
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| EMC
18
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| National Consumers League
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| Vol #:
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| 2
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| EMC
19
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| Pfizer, Inc
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| Vol #:
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| 2
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| EMC
20
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| American Medical Association
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| Vol #:
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| 3
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| EMC
21
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| Merck & Co. Inc.
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| Vol #:
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| 3
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| EMC
22
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| Federal Trade Commission
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| Vol #:
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| 3
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| EMC
23
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| Magazine Publishers of America
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| Vol #:
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| 3
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| ACK 1
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| HFA-305 to Pharmacetucial Distributors Association
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| Vol #:
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| 7
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| EMC
38
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| Healthcare Distribution Management Association
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| Vol #:
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| 7
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| EMC
39
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| Health Industry Group Purchasing Association (HIGPA)
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| Vol #:
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| 7
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| EMC 40
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| HUECK FOILS GmbH & Co. KG
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| Vol #:
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| 7
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| PSA
1
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| Pharmaceutical Distributors Association
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| Vol #:
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| 7
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| 2003N-0390
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| Dental Devices; Gold Based Alloys, Precious Metal Alloys, and Base Metal Alloys; Designation of Special Controls
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| NPR
1
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| FDA
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| Vol #:
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| 1
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| 2003P-0321
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| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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| EMC 82
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| D Gouey
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| Vol #:
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| 2
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| EMC
1
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| Boston University School of Medicine
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| Vol #:
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| 1
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| EMC
2
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| UCLA School of Medicine
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| Vol #:
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| 1
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| EMC
3
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| Thyroid Foundation of America
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| Vol #:
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| 1
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| EMC 4
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| S Brunton MD
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| Vol #:
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| 1
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| EMC 5
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| S Brunton MD
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| Vol #:
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| 1
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