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| Dockets Entered
On May 15, 2007
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| Docket #
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| Title
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2004P-0464
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| Vitamin D & Calcium & Reduced Risk of Osteoporosis
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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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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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005N-0373
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| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| 2006E-0050
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| Patent Extension Application for BYETTA (exenatide injection), U.S. Patent No. 5,424,286
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| 2006N-0525
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| Supplements and Other Changes to an Approved Application
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| 2007D-0117
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| Guidance for Industry on Orally Disintegrating Tablets
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| 2007N-0051
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| Safety of Fresh Produce; Public Hearings
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| 2007N-0068
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| Medical Device User Fee and Modernization Act: Public Meeting
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| 2007N-0114
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| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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| 2007N-0136
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| Medical Devices; Immunology and Microbiology Devices; Classification of Gene Expression Profiling Test System for Breast Cancer Prognosis
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| 2007P-0059
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| Withdrawal of New Animal Drug Application for Posilac - Rombinant Bovine Growth Hormone (rBGH)
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| 2007V-0196
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| Laser Gunsight
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| 2007V-0199
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| Laser Display Device
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| EC 8141
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| Union of Concerned Scientists
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| Vol #:
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| 84
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| EC 8142
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| Union of Concerned Scientists
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| Vol #:
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| 88
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| EC 8143
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| Union of Concerned Scientists
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| Vol #:
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| 90
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| EC 8144
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| Union of Concerned Scientists
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| Vol #:
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| 92
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| 2004P-0464
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| Vitamin D & Calcium & Reduced Risk of Osteoporosis
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| EC 16
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| American Beverage Association
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| Vol #:
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| 13
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| EC 17
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| National Osteoporosis Foundation
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| Vol #:
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| 13
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| EC 18
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| Autoimmunity Research Foundation
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| Vol #:
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| 13
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| EC 19
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| Autoimmunity Research Foundation
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| Vol #:
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| 13
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| EC 20
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| International Dairy Foods Association
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| Vol #:
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| 13
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| EC 21
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| GMA/FPA
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| Vol #:
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| 13
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| EC 22
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| Dairy Management Inc
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| Vol #:
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| 13
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| EC 22
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| Mr. Garry Minor
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| Vol #:
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| 2
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| EC 23
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| Dr. mark thoma
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| Vol #:
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| 2
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| EC 24
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| Miss. melina blum
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| Vol #:
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| 2
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| EC 25
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| Private
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| Vol #:
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| 2
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| EC 26
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| Ms. Kimberly Anderson
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| Vol #:
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| 2
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| EC 27
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| Mrs. Deborah Fisher
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| Vol #:
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| 2
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| EC 28
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| SAG
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| Vol #:
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| 2
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| EC 29
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| Mrs. Susan Trautlein
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| Vol #:
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| 2
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| EC 30
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| Mrs. Rhonda Van Ginkel
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| Vol #:
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| 2
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| EC 31
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| None
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| Vol #:
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| 2
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| EC 32
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| Mrs. Kristina Bedini
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| Vol #:
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| 2
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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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| C 1
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| Grocery Manufacturers/Food Products Association and others
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| Vol #:
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| 1
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| CS 26
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| FDA/DDM
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| Vol #:
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| 240
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| OR 24
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| FDA/Administrative Law Judge
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| Vol #:
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| 240
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| 2005N-0373
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| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
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| C 16
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| WALA Heilmittel GmbH
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| Vol #:
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| 9
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| EC 16
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| USA WTO TBT Inquiry Point, NIST, DOC
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| Vol #:
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| 8
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| EC 17
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| Mrs. Gaylene Kuintzle
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| Vol #:
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| 8
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| EC 18
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| Ms. Casey Baker
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| Vol #:
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| 1
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| EC 19
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| Ms. C Balint
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| Vol #:
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| 8
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| EC 20
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| Glenelg Country School
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| Vol #:
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| 8
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| EC 21
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| Mrs. Nancy Henry
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| Vol #:
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| 8
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| EC 22
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| New Zealand Embassy
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| Vol #:
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| 8
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| EC 23
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| St. Jude Medical
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| Vol #:
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| 8
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| EC 1
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| Columbia University
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| Vol #:
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| 7
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| EC 2
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| Smith
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| Vol #:
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| 7
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| 2006E-0050
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| Patent Extension Application for BYETTA (exenatide injection), U.S. Patent No. 5,424,286
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006N-0525
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| Supplements and Other Changes to an Approved Application
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| TS 14
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| Breakout Session A: Implementation of Quality by Design (QbD) CMC Pilot Program
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| Vol #:
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| 1
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| TS 15
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| Breakout Session B: FDA's Pharmaceutical Quality Initiative Workshop; Product & Process Developm
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| Vol #:
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| 1
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| TS 16
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| Modern Approach to Process Validation
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| Vol #:
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| 1
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| TS 17
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| Breakout Session D: Implementaiton of Quality Systems: Opportunities and Challenges
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| Vol #:
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| 1
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| TS 18
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| Breakout Session: ICH & International Activities (E)
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| Vol #:
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| 1
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| TS 19
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| Breakout Session F: Quality by Design (QbD): Risk-Based Flexible Regulatory Approaches and Regu
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| Vol #:
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| 1
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| TS 20
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| Breakout Session G: OGD's Question-based Review
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| Vol #:
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| 1
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| TS 21
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| Breakout Session: Post-Marketing Regulatory Process
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| Vol #:
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| 1
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| TS 22
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| Breakout Session J: Implementation of Quality Risk Management
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| Vol #:
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| 1
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| 2007D-0117
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| Guidance for Industry on Orally Disintegrating Tablets
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| C 1
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| Akina, Inc.
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| Vol #:
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| 1
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| 2007N-0051
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| Safety of Fresh Produce; Public Hearings
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| C 10
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| H Showalter
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| Vol #:
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| 2
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| EC 4
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| American Farm Bureau Federation
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| Vol #:
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| 2
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| EC 5
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| Mr. m scott
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| Vol #:
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| 2
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| EC 6
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| RARE Hospitality International
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| Vol #:
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| 2
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| EC 7
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| North American Bramble Growers Association
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| Vol #:
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| 2
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| EC 8
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| North Carolina Strawberry Association
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| Vol #:
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| 2
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| EC 9
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| Ms. Caroline Miles
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| Vol #:
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| 2
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| EC 10
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| Mr. GW Seals
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| Vol #:
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| 2
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| 2007N-0068
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| Medical Device User Fee and Modernization Act: Public Meeting
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| EC 6
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| Mr. Marvin Loeb
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| Vol #:
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| 1
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| TR 1
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| Transcript of 4/30/07 Public Meeting
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| Vol #:
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| 2
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| 2007N-0114
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| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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| EC 4
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| Healthcare Distribution Management Association
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| Vol #:
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| 2
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| EC 5
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| Mrs. phyllis Nidek
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| Vol #:
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| 2
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| EC 6
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| Consumers Union
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| Vol #:
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| 2
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| TS 1
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| Glaxo SmithKline (representing PhRMA)
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| Vol #:
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| 1
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| TS 2
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| Hospira (representing GPhA)
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| Vol #:
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| 1
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| TS 3
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| American Pharmacists Association
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| Vol #:
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| 1
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| TS 4
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| Thomson Healthcare
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| Vol #:
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| 1
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| TS 5
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| Genentech, Inc.
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| Vol #:
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| 1
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| TS 6
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| Healthcare Distribution Management Association
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| Vol #:
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| 1
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| 2007N-0136
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| Medical Devices; Immunology and Microbiology Devices; Classification of Gene Expression Profiling Test System for Breast Cancer Prognosis
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| CCP 1
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| Agendia
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| Vol #:
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| 1
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| 2007P-0059
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| Withdrawal of New Animal Drug Application for Posilac - Rombinant Bovine Growth Hormone (rBGH)
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| SUP 1
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| Cancer Prevention Coalition et al
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| Vol #:
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| 1
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