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| Dockets Entered
On September 12, 2006
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| Docket #
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| Title
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| 2005P-0095
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| ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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| 2006E-0023
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 and NDA 21-754), U.S. Patent No. 6,107,458
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| 2006E-0345
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 & NDA 21-754), U.S. Patent No. 6,265,536
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| 2006P-0094
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| To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| 2006P-0370
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| Revoke FDA's prior approval of vagus nerve stimulation (VNS) for mangement of treatment-resistant depression (TRD)
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| 2006P-0375
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| Banning of Urogender Test
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| 2006P-0376
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| Banning of Acu-Gender Blood Test
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| 2006V-0377
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| Laser Light Show
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| EC 22
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| Mr. Ron Johnston
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| Vol #:
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| 8
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| EC 20
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| Mr. David N. Carey
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| Vol #:
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| 2
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| CS 17
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| FDA/DDM
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| Vol #:
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| 6
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| MO 18
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| FDA/CDRH andTMJ Implants, Inc.
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| Vol #:
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| 6
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| OR 17
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| FDA/Administrative Law Judge
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| Vol #:
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| 6
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| TS 1
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| Tibotec, Inc.
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| Vol #:
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| 2
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| 2005P-0095
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| ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP
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| RC 1
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| Luitpold Pharmaceuticals, Inc.
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| 2
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| EC 12
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| American Heart Association
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| Vol #:
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| 1
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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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| BKG 1
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| Guidance
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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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| 2006E-0023
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 and NDA 21-754), U.S. Patent No. 6,107,458
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| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 2
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| LET 7
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 2
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| 2006E-0345
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 & NDA 21-754), U.S. Patent No. 6,265,536
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| 1
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| 1
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| 2006P-0094
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| To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
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| LET 1
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| FDA/CFSAN to The Sugar Association, Inc.
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| Vol #:
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| 2
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| EC 685
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| Annunciation Catholic Church Pro-Life committee
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| Vol #:
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| 5
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| EC 686
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| Mr. Jeff Leonard
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| Vol #:
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| 5
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| EC 687
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| Mr. David Clemens
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| Vol #:
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| 5
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| EC 688
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| Mr. Mike Jacobs
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| Vol #:
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| 5
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| EC 689
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| None
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| Vol #:
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| 5
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| EC 690
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| Grassroots
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| Vol #:
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| 5
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| EC 691
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| Ms. Nicole Morse
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| Vol #:
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| 5
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| EC 692
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| www.nara.ac.lk
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| Vol #:
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| 5
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| 2006P-0370
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| Revoke FDA's prior approval of vagus nerve stimulation (VNS) for mangement of treatment-resistant depression (TRD)
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| LET 1
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| Public Citizen
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| Vol #:
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| 1
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| 2006P-0375
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| Banning of Urogender Test
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| ACK 1
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| FDA/DDMB to John D. Stephens, M.D.
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| Vol #:
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| 1
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| CP 1
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| John D. Stephens, M.D.
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| Vol #:
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| 1
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| 2006P-0376
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| Banning of Acu-Gender Blood Test
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| ACK 1
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| FDA/DDMB to John D. Stephens, M.D.
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| Vol #:
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| 1
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| CP 1
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| John D. Stephens, M.D.
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| Vol #:
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| 1
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| 2006V-0377
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| Laser Light Show
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| ACK 1
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| FDA /DDM to Evans & Sutherland Computer Corporation
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| Vol #:
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| 1
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| VAR 1
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| Evans & Sutherland Computer Corporation
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| Vol #:
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| 1
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