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| Dockets Entered
On August 3, 2006
Table of Contents
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999E-5113
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| Patent Extension: Clinacox (diclazuril), #4,631,278
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000D-1306
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| Content & Format of the Adverse Reactions Section of Labeling
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| 2001D-0489
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| Establishment & Operation of Clinical Trial Monitoring Comm
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2003D-0001
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| Nonclinical Safety Evaluation of Pediatric Drug Products
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| 2003E-0418
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| Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147
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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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| 2003N-0355
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| Medical Devices; Exception from General Requirements for Informed Consent
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2005D-0195
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| Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
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| 2005D-0401
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| Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended Prominent and Conspicuous Mark of Manufacturers on Single-Us
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0458
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| Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired.
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| 2006D-0121
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| Guidance for Industry and Food and Drug Administration: In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path
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| 2006E-0004
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| Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
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| 2006E-0189
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| Patent Extension Application for IPLEX (mecasermin rinfabate rDNA origin injection), U.S. Patent No. 5,681,818
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| 2006N-0202
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| 2006P-0209
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| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
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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-0306
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| Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone
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| 2006P-0307
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| To amend 21CFR 201.17 regarding expiration dates
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| 1976N-0052N
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| OTC Nasal Decongestants
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| NFR 3
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| FDA
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| Vol #:
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| 86
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 17991
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| Econet Inc dba Oasis LifeSciences
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| Vol #:
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| 166
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| LET 17992
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| Hillestad Pharmaceuticals
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| Vol #:
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| 166
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| LET 17993
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| NewMark: A Division of New Chapter Inc
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| Vol #:
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| 166
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| LET 17994
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| NewMark: A Division of New Chapter Inc
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| Vol #:
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| 166
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| LET 17995
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| NewMark: A Division of New Chapter Inc
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| Vol #:
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| 166
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| LET 17996
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| NewMark: A Division of New Chapter Inc
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| Vol #:
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| 166
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| LET 17997
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| NewMark: A Division of New Chapter Inc
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| Vol #:
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| 166
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| LET 17998
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| NewMark: A Division of New Chapter Inc
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| Vol #:
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| 166
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| LET 17999
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| NewMark: A Division of New Chapter Inc
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| Vol #:
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| 166
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| LET 18000
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| NewMark: A Division of New Chapter Inc
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| Vol #:
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| 166
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| LET 18001
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| NewMark: A Division of New Chapter Inc
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| Vol #:
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| 166
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| LET 18002
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| NewMark: A Division of New Chapter, Inc.
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| Vol #:
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| 166
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| LET 18003
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| NewMark: A Division of New Chapter, Inc.
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| Vol #:
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| 166
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| LET 18004
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| NewMark: A Division of New Chapter, Inc.
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| Vol #:
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| 166
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| LET 18005
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| NewMark: A Division of New Chapter, Inc.
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| Vol #:
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| 166
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| LET 18006
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| NewMark: A Division of New Chapter, Inc.
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| Vol #:
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| 166
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| LET 18007
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| NewMark: A Division of New Chapter, Inc.
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| Vol #:
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| 166
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| LET 18008
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| NewMark: A Division of New Chapter, Inc.
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| Vol #:
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| 166
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| LET 18009
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| NewMark: A Division of New Chapter, Inc.
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| Vol #:
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| 166
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| LET 18010
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| Haussler Nutritionals
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| Vol #:
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| 166
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| LET 18011
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| BioAdvantex Pharma Inc
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| Vol #:
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| 166
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| LET 18012
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| Natrol Inc
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| Vol #:
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| 166
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| LET 18013
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| Davisco Food International Inc
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| Vol #:
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| 166
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| LET 18014
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| Pure Encapsulations
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| Vol #:
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| 166
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7534
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| R. Downing
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| Vol #:
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| 339
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| 1999E-5113
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| Patent Extension: Clinacox (diclazuril), #4,631,278
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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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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| C 762
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| E Montgomery
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| Vol #:
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| 21
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| 2000D-1306
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| Content & Format of the Adverse Reactions Section of Labeling
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| EC 14
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2001D-0489
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| Establishment & Operation of Clinical Trial Monitoring Comm
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| EC 16
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| EC 17
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| EC 2
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| Mr. Dave Lowe
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| Vol #:
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| 7
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| 2003D-0001
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| Nonclinical Safety Evaluation of Pediatric Drug Products
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| EC 2
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2003E-0418
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| Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147
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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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| 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 16
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| Mr. Dave Lowe
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| Vol #:
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| 7
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| 2003N-0355
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| Medical Devices; Exception from General Requirements for Informed Consent
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| EC 6
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| Harris Co. Public Health
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| Vol #:
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| 1
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| EC 515
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| Mr. Dave Lowe
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| Vol #:
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| 17
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| EC 516
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| Ms. Sherri Iandolo
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| Vol #:
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| 17
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| 2005D-0195
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| Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
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| EC 7
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2005D-0401
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| Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended Prominent and Conspicuous Mark of Manufacturers on Single-Us
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| EC 2
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| EC 19
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| Ms. Kristine Davis
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 17990
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| J. Gilreath
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| Vol #:
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| 194
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| C 17991
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| N. Phillips
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| Vol #:
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| 194
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| C 17992
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| A. Oldroyd
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| Vol #:
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| 194
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| 2005P-0458
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| Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired.
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| LST 1
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| Proposed Meeting Agenda: ChloraPrep with Tint
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| Vol #:
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| 1
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| MM 1
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| FDA/CDER and Medi-Flex, Inc
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| Vol #:
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| 1
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| TS 1
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| Medi-Flex, Inc
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| Vol #:
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| 1
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| 2006D-0121
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| Guidance for Industry and Food and Drug Administration: In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path
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|
|
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006E-0004
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| Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
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|
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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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| | | | | | | | |
|
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| 2006E-0189
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| Patent Extension Application for IPLEX (mecasermin rinfabate rDNA origin injection), U.S. Patent No. 5,681,818
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|
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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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| 2006N-0202
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| C 2
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| FedEx Express
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| Vol #:
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| 1
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| EC 681
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| Miss. Liliana Lyderup
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| Vol #:
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| 3
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| EC 682
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| SalineSupport on Yahoo groups
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| Vol #:
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| 3
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| EC 683
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| Ms. Jeanie Williams-West
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| Vol #:
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| 3
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| 2006P-0209
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| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
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| EC 15
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| Mr. Dave Lowe
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| Vol #:
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| 1
|
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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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| C 1
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| W Depner
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| Vol #:
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| 1
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| 2006P-0306
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| Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone
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|
|
|
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| ACK 1
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| FDA/DDM to Office of Governor Tim Pawlenty
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| Vol #:
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| 1
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| CP 1
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| The States of Kansas, Minnesota, Vermont and Wisconsin
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| Vol #:
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| 1
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| 2006P-0307
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| To amend 21CFR 201.17 regarding expiration dates
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|
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| ACK 1
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| FDA/DDM to University of California
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| Vol #:
|
| 1
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| CP 1
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| University of California
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| Vol #:
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| 1
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