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| Dockets Entered
On May 14, 2007
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| Docket #
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| Title
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| 1978N-0036L
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| OTC Laxative
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| 1978N-0301H
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| External Analgesic Drug Products for OTC Human Use
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| 1998N-0337C
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| Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2004E-0444
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| Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814
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| 2004P-0140
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| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
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| 2005E-0253
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| Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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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-0417
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| ANDA for Tretinoin Cream Drug Products in Strengths of 0.0375% and 0.075%
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| 2005P-0460
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| Determination of Ramipril Tablets, 1.25 mg, 2.5 mg, 5 mg and 10 mg
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| 2006D-0480
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| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2007D-0040
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| Guidance for Industry on Developing Products for Weight Management
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| 2007N-0016
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| Sentinel Network To Promote Medical Product Safety
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| 2007N-0019
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| Medical Devices; Anesthesiology Devices; Oxygen Pressure Regulators and Oxygen Conserving Devices
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| 2007N-0053
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations
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| 2007N-0068
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| Medical Device User Fee and Modernization Act: Public Meeting
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 2007N-0165
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice
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| 2007N-0182
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Databank
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| 2007P-0060
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| ANDA Suitability for Hydrocortisone Tablets USP, 10 mg, (CORTEF) and Determine if CORTEF was Withdrawn for Safety or Efficacy Reasons
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| 2007P-0074
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| Take specific action with respect to 21 CFR 341, the Final Monograph for Cough, Cold Allergy, Bronchodilator, Antiasthmatic Drug Products for Over-the-Counter Human Use
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| 2007P-0194
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| to permit the filingof an abbreviated new drug application (ANDA) for Acetaminophen, Butalbital, Caffeine and Hydrocodone Bitartrate Capsules
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| 1978N-0036L
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| OTC Laxative
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| C 218
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| MADAUS GmbH
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| Vol #:
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| 138
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| 1978N-0301H
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| External Analgesic Drug Products for OTC Human Use
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| ACK 2
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| FDA/DDM to McKenna & Cuneo
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| 7
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| 1998N-0337C
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| Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
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| C 2
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| CTFA, Cosmetic, Toiletry and Fragrance Association
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| Vol #:
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| 1
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| EC 5
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| Consumer Healthcare Products Association
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| Vol #:
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| 1
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| C 10018
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| C. Adrian
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| Vol #:
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| 580
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1416
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| J. Turba
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| Vol #:
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| 262
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| EC 8140
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| Union of Concerned Scientists
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| Vol #:
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| 84
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| 2004E-0444
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| Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814
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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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| 2004P-0140
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| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
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| SUP 7
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| Mutual Pharmaceutical Co., Inc
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| Vol #:
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| 6
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| 2005E-0253
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| Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498
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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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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| RMO 11
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| FDA/CDRH/OGC
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| Vol #:
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| 240
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| C 28
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| Natural Beverage Leader
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| Vol #:
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| 1
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| C 29
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| M. McClennen
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| Vol #:
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| 1
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| C 740
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| Association des Amidonniers et Feculliers
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| Vol #:
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| 35
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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 18305
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| S. Smith
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| Vol #:
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| 198
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| 2005P-0417
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| ANDA for Tretinoin Cream Drug Products in Strengths of 0.0375% and 0.075%
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| PAV 1
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| FDA/CDER to Triax Pharmaceuticals, LLC
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| Vol #:
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| 1
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| 2005P-0460
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| Determination of Ramipril Tablets, 1.25 mg, 2.5 mg, 5 mg and 10 mg
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| WDL 1
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| Lachman Consultant Services Inc.
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| Vol #:
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| 1
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| 2006D-0480
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| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
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| EC 142
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| Mr. Paul V. Howard
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| Vol #:
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| 6
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| EC 143
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| Mrs. Nanette Campbell
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| Vol #:
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| 6
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| EC 144
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| N/A
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| Vol #:
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| 6
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| EC 145
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| Ms. Michelle Chrisman
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| Vol #:
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| 6
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| C 91
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| A. Nussbaum
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| Vol #:
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| 7
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| C 92
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| Voiceless-The Fund For Animals
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| Vol #:
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| 7
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| 2007D-0040
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| Guidance for Industry on Developing Products for Weight Management
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| C 7
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| Hoffmann-la Roche Inc
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| Vol #:
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| 1
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| 2007N-0016
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| Sentinel Network To Promote Medical Product Safety
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| REF 1
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| Article - Medical Device Epidemiology
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| Vol #:
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| 6
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| REF 2
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| Article - Surveillance of adverse medical device events
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| Vol #:
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| 6
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| 2007N-0019
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| Medical Devices; Anesthesiology Devices; Oxygen Pressure Regulators and Oxygen Conserving Devices
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| C 1
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| A. S. T. M. International
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| Vol #:
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| 1
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| C 2
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| Airgas
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| Vol #:
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| 1
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| 2007N-0053
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations
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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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| 2007N-0068
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| Medical Device User Fee and Modernization Act: Public Meeting
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| EC 3
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| TMJ Concepts
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| Vol #:
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| 1
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| EC 4
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| DTA
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| Vol #:
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| 1
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| EC 5
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| Alliance of Specialty Medicine
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| Vol #:
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| 1
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| TS 1
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| Medical Device User Fee and Modernization Act (MDUFMA II) - Legislative Recommendations
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| Vol #:
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| 1
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| TS 2
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| National Venture Capital Association
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| Vol #:
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| 1
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| EAPE 183
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| Dorlester, Dianne
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| Vol #:
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| 1
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| EAPE 184
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| Lang, William
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| Vol #:
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| 1
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| EAPE 185
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| Ng, Anthony
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| Vol #:
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| 1
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| EAPE 188
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| Brueckl, Mark
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| Vol #:
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| 1
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| EAPE 189
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| Hillmer, Tania
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| Vol #:
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| 1
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| EAPE 190
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| Craddock, Marissa
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| Vol #:
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| 1
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| EAPE 191
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| Garrett, Daniel
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| Vol #:
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| 1
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| EAPE 192
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| Daignault, Danielle
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| Vol #:
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| 1
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| EAPE 193
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| Dillahunt, Michelle
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| Vol #:
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| 1
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| EAPE 194
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| Daignault, Danielle
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| Vol #:
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| 1
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| EAPE 195
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| Douglas, Scott
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| Vol #:
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| 1
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| EAPE 196
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| Day, Ruth
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| Vol #:
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| 1
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| EAPE 197
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| Paul, Kala
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| Vol #:
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| 1
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| EAPE 198
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| Burkholder, Rebecca
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| Vol #:
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| 1
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| EC 3
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| Central Virginia Health Services, Inc
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| Vol #:
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| 6
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| 2007N-0165
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice
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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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| 2007N-0182
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Databank
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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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| 2007P-0060
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| ANDA Suitability for Hydrocortisone Tablets USP, 10 mg, (CORTEF) and Determine if CORTEF was Withdrawn for Safety or Efficacy Reasons
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| WDL 1
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| West-ward Pharmaceutical Corporation
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| Vol #:
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| 1
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| 2007P-0074
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| Take specific action with respect to 21 CFR 341, the Final Monograph for Cough, Cold Allergy, Bronchodilator, Antiasthmatic Drug Products for Over-the-Counter Human Use
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| SUP 1
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| Baltimore city Health Department
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| Vol #:
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| 1
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| 2007P-0194
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| to permit the filingof an abbreviated new drug application (ANDA) for Acetaminophen, Butalbital, Caffeine and Hydrocodone Bitartrate Capsules
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| ACK 1
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| FDA / DDM to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| CP 1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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