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| Dockets Entered
On March 30, 2005
Table of Contents
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| Docket #
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| Title
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| 1975P-0144
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| Amend Soda Water Standards
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| 1977P-0051
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| Food Labeling; Designation of Ingred re: Nutritive Sweete
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| 1977P-0357
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| Parenthetic List; Nutritive Sweets/Label of Bread Products
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| 1984P-0029
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| SUGAR LABELING
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2001N-0541
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| Debarment of Eduardo Caro Acevedo
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2003F-0471
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| Filing of Food Additive Petition (FAP 3A4749)
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| 2004D-0187
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| Guidance for Industry on Premarketing Risk Assessment
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| 2004D-0188
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| Guidance for Industry on Development and Use of Risk Minimization Action Plans
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| 2004D-0189
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| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
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| 2004N-0050
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient
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| 2004N-0534
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for Over-The Counter (OTC) Drug Product Labeling
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| 2004N-0554
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Irradiation in the Production, Processing and Handling of Food
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| 2005D-0004
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| Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations
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| 2005D-0106
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| Guidance for Industry on Systemic Lupus Erythematosus Developing Drugs for Treatment
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 2005N-0077
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| Color Additive Certification; Increase in Fees for Certification Services
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| 2005N-0102
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| Referral of Kemstro (Baclofen) and Droxia (Hydroxyurea) for the Conduct of Pediatric Studies
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| 2005P-0121
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| None-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| 1975P-0144
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| Amend Soda Water Standards
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| M
1
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| Memorandum for the Record
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| Vol #:
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| 1
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| 1977P-0051
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| Food Labeling; Designation of Ingred re: Nutritive Sweete
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| M
1
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| Memorandum to the Record
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| 1
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| 1977P-0357
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| Parenthetic List; Nutritive Sweets/Label of Bread Products
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| M
1
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| Memorandum for the Record
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| Vol #:
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| 1
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| 1984P-0029
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| SUGAR LABELING
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| M
1
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| Memornadum for the Record
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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
39
Attachment
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| Northfield Laboratorie Inc, BB IND 10719, Poly-SFH-P Injection
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| Vol #:
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| 43
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
15808
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| New Chapter, Inc.
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| Vol #:
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| 139
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| LET
15809
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| Botanical Laboratories, Inc.
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| Vol #:
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| 139
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| LET
15810
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| Botanical Laboratories, Inc.
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| Vol #:
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| 139
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| LET
15811
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| Botanical Laboatroeis, Inc.
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| Vol #:
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| 139
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| LET
15812
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| Botanical Laboatories, Inc.
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| Vol #:
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| 139
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| LET
15813
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| Metagenics, Inc.
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| Vol #:
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| 139
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| LET
15814
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| North American Pharmacal Inc.
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| Vol #:
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| 139
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| LET
15815
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| North American Pharmacal Inc.
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| Vol #:
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| 139
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| LET
15816
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| North American Pharmacal Inc.
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| Vol #:
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| 139
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| LET
15817
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| North American Pharmacal Inc.
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| Vol #:
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| 139
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| LET
15818
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| Procter and Gamble
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| Vol #:
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| 139
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| LET
15819
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| Botanic Oil Innovations, Inc.
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| Vol #:
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| 139
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| LET
15820
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| Perrigo Company of South Carolina
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| Vol #:
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| 139
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| LET
15821
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| Perrigo Company of South Carolina
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| Vol #:
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| 139
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| LET
15822
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| Perrigo Company of South Carolina
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| Vol #:
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| 139
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| LET
15823
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| Perrigo Company of South Carolina
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| Vol #:
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| 139
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| LET
15824
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| Enzymatic Therapy
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| Vol #:
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| 139
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| LET
15825
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| Enzymatic Therapy
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| Vol #:
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| 139
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| LET
15826
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| Enzymatic Therapy
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| Vol #:
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| 139
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| LET
15827
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| Enzymatic Therapy
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| Vol #:
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| 139
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| LET
15828
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| Enzymatic Therapy
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| Vol #:
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| 139
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| LET
15829
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| Enzymatic Therapy
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| Vol #:
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| 139
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| LET
15830
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| Barmensen Labs, LLC
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| Vol #:
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| 139
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| LET
15831
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| McNeil Nutritionals, LLC
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| Vol #:
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| 139
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| LET
15832
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| Halleujah Acres
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| Vol #:
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| 139
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 1125
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| Bayer Corporation
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| Vol #:
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| 468
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| 2001N-0541
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| Debarment of Eduardo Caro Acevedo
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| LET 2
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| HFA-305 to Eduardo Caro Acevedo, M.D.
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| Vol #:
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| 1
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| EMC 14371
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| H Souza
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| Vol #:
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| 342
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| EMC 14372
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| S Runquist
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| Vol #:
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| 342
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| EMC 14373
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| N Rann
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| Vol #:
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| 342
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| EMC 14374
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| N Rann
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| Vol #:
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| 342
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| EMC 14375
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| M Smithson
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| Vol #:
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| 342
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| EMC 14376
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| L
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| Vol #:
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| 342
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| EMC 14377
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| L Regalado
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| Vol #:
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| 342
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| EMC 14378
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| L Regalado
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| Vol #:
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| 342
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| EMC 14379
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| L Bailey
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| Vol #:
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| 342
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| EMC 14380
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| J Allen
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| Vol #:
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| 342
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| EMC 14381
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| J Miller
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| Vol #:
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| 342
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| EMC 14382
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| C Mott
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| Vol #:
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| 342
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| MM
15
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| Meeting between FDA and US Customs and Border Protection
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| Vol #:
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| 30
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| |
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| 2003F-0471
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| Filing of Food Additive Petition (FAP 3A4749)
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| BKG
1
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| Background Material
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| Vol #:
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| 1
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 2004D-0187
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| Guidance for Industry on Premarketing Risk Assessment
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| GDL
2
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| Guidance
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| Vol #:
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| 2
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| NAD
2
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| FDA
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| Vol #:
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| 2
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| 2004D-0188
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| Guidance for Industry on Development and Use of Risk Minimization Action Plans
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| GDL
2
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| Guidance
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| Vol #:
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| 2
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| NAD
2
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| FDA
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| Vol #:
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| 2
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| 2004D-0189
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| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
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| GDL
2
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| Guidance
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| Vol #:
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| 2
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| NAD
2
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| FDA
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| Vol #:
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| 2
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| 2004N-0050
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient
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| SUP
1
Attachment
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| Clariant GmbH
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| Vol #:
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| 2
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| 2004N-0534
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for Over-The Counter (OTC) Drug Product Labeling
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2004N-0554
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Irradiation in the Production, Processing and Handling of Food
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2005D-0004
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| Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations
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| C 1
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| David H McGee PHD
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| Vol #:
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| 1
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| |
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| 2005D-0106
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| Guidance for Industry on Systemic Lupus Erythematosus Developing Drugs for Treatment
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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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| NAD
1
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| FDA
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| Vol #:
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| 1
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| |
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| C
3
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| Aultman Health Foundation
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| Vol #:
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| 3
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| EC 15
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| Mrs. Venessia Johnson
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| Vol #:
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| 3
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| EMC
3
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| Cancer Therapy Evaluation Program, NCI
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| Vol #:
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| 3
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| LST
4
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| List of attendees to March 21, 2005 hearing
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| Vol #:
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| 3
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| TR
1
Part
2, part
3
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| Transcript of the March 21, 2005 Hearing
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| Vol #:
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| 4
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| TS
10
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| Medical College of Wisconsin
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| Vol #:
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| 2
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| TS
11
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| Eli Lilly and Company
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| Vol #:
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| 2
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| TS
12
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| PhRMA
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| Vol #:
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| 2
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| TS
13
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| Public Responsibility in Medicine and Research (PRIM&R)
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| Vol #:
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| 2
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| TS
14
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| Applied Research Ethics National Association (ARENA)
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| Vol #:
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| 2
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| TS
15
Attachment
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| Council for International Organizations of Medical Sciences VI Working Group
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| Vol #:
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| 2
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| TS
16
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| Association of Clinical Research Professionals
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| Vol #:
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| 2
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| TS
17
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| Georgetown University Medical Center
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| Vol #:
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| 2
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| TS
18
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| Chesapeake Research Review Inc
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| Vol #:
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| 3
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| 2005N-0077
|
| Color Additive Certification; Increase in Fees for Certification Services
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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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| 2005N-0102
|
| Referral of Kemstro (Baclofen) and Droxia (Hydroxyurea) for the Conduct of Pediatric Studies
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| N
1
|
| FDA
|
| Vol #:
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| 1
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| 2005P-0121
|
| None-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| ACK
1
|
| HFA-305 to RS Medical
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| Vol #:
|
| 1
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| CCP
1
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| RS Medical
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| Vol #:
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| 1
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