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| Dockets Entered
On September 19, 2006
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| Docket #
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| Title
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| 1997D-0318
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| Revised Precautionary Measure to Reduce Transmission of CJD
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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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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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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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-0456
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| Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons
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| 2006D-0063
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| Draft Guidance for Industry and Food and Drug Administration; The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program; Availability
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| 2006D-0228
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| Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program
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| 2006D-0246
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| Manufactured Food Regulatory Program Standards
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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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| 2006M-0368
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| H040006 - AbioCor Replacement Heart
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| 2006N-0106
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| New Animal Drugs; Adamantane and Neuraminidase Inhibitor Anti-influenza Drugs; Extralabel Animal Drug Use; Order of Prohibition
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| 2006N-0166
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| Agency Emergency Processing Under OMB Review; MedWatch - The FDA Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners organizations
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| 2006N-0292
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| Unique Device Identification
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| 2006P-0140
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| To withhold approval of any ANDA for a generic version of acitretin capsules
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| 2006P-0173
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| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
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| 2006P-0195
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| Determine that Wyeth Pharmaceuticals, Inc. discontinued its original formulation of Zosyn (piperacillin and tazobactam) for reasons unrelated to safety and efficacy and to allow companies to file Abbr
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| 2006P-0210
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| Amend regulations for products composed of engineered nanoparticles generally and sunscreen drug products composed of engineered nanoparticles specifically
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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-0271
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| Amend practice of assessing the performance of medical devices for determining in vitro susceptibility of bacteria or fungi to included CLSI.
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| 2006P-0311
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| Investigate and take regulatory action to protect surgical patients from a potential significant safety risk in connection with Propofol Injectable Emulsion marketed by Bedford Laboratories
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| 2006P-0348
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| Amend the vancomycin HCl package insert to reflect modifications of the antimicrobial susceptibility interpretive criteria to better recognize emerging resistance resulting in compromised patient outc
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| 2006P-0369
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| ANDA Suitability for Alclometasone Dipropionate Lotion, 0.05%
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| 2006P-0390
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| Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
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| 1997D-0318
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| Revised Precautionary Measure to Reduce Transmission of CJD
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| EC 12
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| Ms. Kay Gregory
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| Vol #:
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| 3
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| EC 13
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| Ms. Debra Kessler
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| Vol #:
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| 3
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1394
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| L. Chauvin
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| Vol #:
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| 259
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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 24
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| Mr. willa wonka
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| Vol #:
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| 8
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| LET 1
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| Foods & Water Watch
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| Vol #:
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| 5
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| EMC 470
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| J. Pippin
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| Vol #:
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| 165
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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 18134
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| T. Corley
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| Vol #:
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| 196
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| C 18135
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| T. Flocken
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| Vol #:
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| 196
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| C 18136
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| N. Goodin
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| Vol #:
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| 196
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| 2005P-0456
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| Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons
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| C 8
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| Wyeth Pharmaceuticals
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| Vol #:
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| 2
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| 2006D-0063
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| Draft Guidance for Industry and Food and Drug Administration; The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program; Availability
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| EC 1
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| AdvaMed
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| Vol #:
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| 1
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| 2006D-0228
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| Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program
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| EC 1
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| Roche Molecular Systems
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| Vol #:
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| 1
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| 2006D-0246
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| Manufactured Food Regulatory Program Standards
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| C 3
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| Wisconsin dDepartment of Agriculture, Trade and Consumer Protection
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| 1
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| EC 1
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| Association of Food and Drug Officials
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| Vol #:
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| 1
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| EC 2
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| Alaska Department of Environmental Conservation
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| Vol #:
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| 1
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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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| C 2
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| John Hopkins School of Medicine
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| Vol #:
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| 1
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| C 3
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| Oregon Health & Sciences University
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| Vol #:
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| 1
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| EC 21
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| Dr. Mark Slagle
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| Vol #:
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| 1
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| EC 22
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| Oregon Health & Sciences University
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| Vol #:
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| 1
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| EC 23
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| Ms. J. Eastus Evans
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| Vol #:
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| 1
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| 2006M-0368
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| H040006 - AbioCor Replacement Heart
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| AAV 1
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| Abiomed, Inc.
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| Vol #:
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| 1
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| 2006N-0106
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| New Animal Drugs; Adamantane and Neuraminidase Inhibitor Anti-influenza Drugs; Extralabel Animal Drug Use; Order of Prohibition
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| EMC 3
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| Keep Antibotics Working (KAW)
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| Vol #:
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| 2
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| 2006N-0166
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| Agency Emergency Processing Under OMB Review; MedWatch - The FDA Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners organizations
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| EMC 1
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| B. Sachau
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| Vol #:
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| 1
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| 2006N-0292
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| Unique Device Identification
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| EC 18
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| FDA/CDRH
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| Vol #:
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| 1
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| EC 19
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| Baxa Corporation
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| Vol #:
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| 1
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| 2006P-0140
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| To withhold approval of any ANDA for a generic version of acitretin capsules
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| LET 1
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| FDA/CDER to Connetics Corporation
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| Vol #:
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| 1
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| 2006P-0173
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| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
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| C 2
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| Wyeth Pharmaceuticals
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| Vol #:
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| 1
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| 2006P-0195
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| Determine that Wyeth Pharmaceuticals, Inc. discontinued its original formulation of Zosyn (piperacillin and tazobactam) for reasons unrelated to safety and efficacy and to allow companies to file Abbr
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| C 2
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| Wyeth Pharmaceuticals
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| Vol #:
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| 1
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| 2006P-0210
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| Amend regulations for products composed of engineered nanoparticles generally and sunscreen drug products composed of engineered nanoparticles specifically
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| C 2
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| Cosmetic, Toiletry and Frangrance Association (CTFA)
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| Vol #:
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| 4
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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 704
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| Mr. Loren Hegge
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| Vol #:
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| 5
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| EC 705
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| Ms. Rebecca Corrente
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| Vol #:
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| 5
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| 2006P-0271
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| Amend practice of assessing the performance of medical devices for determining in vitro susceptibility of bacteria or fungi to included CLSI.
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| EC 2
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| Infectious Diseases Society of America
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| Vol #:
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| 2
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| 2006P-0311
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| Investigate and take regulatory action to protect surgical patients from a potential significant safety risk in connection with Propofol Injectable Emulsion marketed by Bedford Laboratories
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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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| 2006P-0348
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| Amend the vancomycin HCl package insert to reflect modifications of the antimicrobial susceptibility interpretive criteria to better recognize emerging resistance resulting in compromised patient outc
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| EC 4
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| Infectious Diseases Society of America
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| Vol #:
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| 2
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| 2006P-0369
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| ANDA Suitability for Alclometasone Dipropionate Lotion, 0.05%
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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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| 2006P-0390
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| Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
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| ACK 1
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| FDA/DDM to Jerry Staton
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| Vol #:
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| 1
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| CP 1
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| Jerry Staton
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| Vol #:
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| 1
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