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| Dockets Entered
On September 18, 2006
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| Docket #
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| Title
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| 1995N-0309
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| CGMPs for the Production of Infant Formula
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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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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| 2004P-0520
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| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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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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| 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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| 2006E-0005
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| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,001,876
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| 2006E-0006
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| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,197,819
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| 2006E-0024
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| Patent Extension Application for VNS Therapy System, U.S. Patent No. 5,299,569
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006P-0125
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| Determine whether Dexedrine (dextroamphetamine sulfate) Oral Solution 5 mg/ 5 mL has been voluntarily withdrawn from sale for safety or efficacy reasons
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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-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-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-0370
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| Revoke FDA's prior approval of vagus nerve stimulation (VNS) for mangement of treatment-resistant depression (TRD)
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| 2006P-0372
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| Determine whether Mepron (atovaquone) Tablets, 250 mg, has been voluntarily withdrawn from sale for safety or efficacy reasons
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| 2006V-0388
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| Projector for a Laser Light Show
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| 1995N-0309
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| CGMPs for the Production of Infant Formula
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| EC 8
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| PBM Nutritionals
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| Vol #:
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| 13
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1393
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| K. Bandstra
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| Vol #:
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| 259
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| REF 2
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| OMB Review for Substances Prohibted From Use in Animal Food or Feed
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| Vol #:
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| 46
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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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| C 65
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| K. Bandstra
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| Vol #:
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| 5
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| 2004P-0520
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| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
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| WDL 1
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| Teva Pharmaceuticals, USA (TEVA)
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| Vol #:
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| 2
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| EC 21
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| Mrs. Susan Barton
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| Vol #:
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| 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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| C 18113
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| L. Eckhardt
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| Vol #:
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| 196
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| C 18114
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| United States House of Represenatives
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| Vol #:
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| 196
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| C 18115
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| C. Salon
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| Vol #:
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| 196
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| C 18116
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| C. Turner
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| Vol #:
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| 196
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| C 18117
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| B. Nielsen
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| Vol #:
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| 196
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| C 18118
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| M. O'Connor
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| Vol #:
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| 196
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| C 18119
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| D. Hall
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| Vol #:
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| 196
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| C 18120
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| C. Brochu
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| Vol #:
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| 196
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| C 18121
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| B. Peterson
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| Vol #:
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| 196
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| C 18122
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| J. Hoeschler
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| Vol #:
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| 196
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| C 18123
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| C. Donovan
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| Vol #:
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| 196
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| C 18124
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| M. Gilliam
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| Vol #:
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| 196
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| C 18125
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| C. Crumley
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| Vol #:
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| 196
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| C 18126
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| D'Amico
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| Vol #:
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| 196
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| C 18127
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| C. Pohle
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| Vol #:
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| 196
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| C 18128
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| K. Lopez
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| Vol #:
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| 196
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| C 18129
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| P. O'Brien
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| Vol #:
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| 196
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| C 18130
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| M. Dudai
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| Vol #:
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| 196
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| C 18131
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| T. Jones
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| Vol #:
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| 196
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| C 18132
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| V. Burroughs
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| Vol #:
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| 196
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| C 18133
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| L. Quigley
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| Vol #:
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| 196
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| 2006D-0246
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| Manufactured Food Regulatory Program Standards
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| C 1
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| Texas Department of State Health Services (DSHS)
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| Vol #:
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| 1
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| C 2
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| Abbott Laboratories
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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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| EC 16
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| Mr. Rick Heidel
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| Vol #:
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| 1
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| EC 17
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| Mr. Peter Bodenbach
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| Vol #:
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| 1
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| EC 18
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| Mr. Rick Heidel
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| Vol #:
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| 1
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| EC 19
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| Mr. Luis Howard f Howard fami
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| Vol #:
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| 1
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| EC 20
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006E-0005
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| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,001,876
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| LET 3
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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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| RPT 1
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| Trans-agency Working Group on the Health Effects of Dental Amalgam US Department of Heath and
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| Vol #:
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| 7
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| RPT 2
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| International Academy of Oral Medicine and Toxicology
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| Vol #:
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| 8
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| SUP 1
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| R. Edlich, M.D., PhD
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| Vol #:
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| 1
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| SUP 2
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| A. Kerimian, PhD
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| Vol #:
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| 9
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| TS 23
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| M. Flowers
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| Vol #:
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| 1
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| TS 24
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| T. Klausen
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| Vol #:
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| 1
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| 2006P-0125
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| Determine whether Dexedrine (dextroamphetamine sulfate) Oral Solution 5 mg/ 5 mL has been voluntarily withdrawn from sale for safety or efficacy reasons
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| LET 1
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| FDA/DDM to CDER
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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 722
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| Ms. Sonia Dunkinson
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| Vol #:
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| 3
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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 700
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| Mrs. Bethany Perry
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| Vol #:
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| 5
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| EC 701
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| self
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| Vol #:
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| 5
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| EC 702
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| N/A
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| Vol #:
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| 5
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| EC 703
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| Mrs. Thelma Kesl
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| Vol #:
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| 5
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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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| EC 1
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| Consumers Union, publisher of Consumer Reports
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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 3
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| Mr. Dave Lowe
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| Vol #:
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| 3
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| 2006P-0370
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| Revoke FDA's prior approval of vagus nerve stimulation (VNS) for mangement of treatment-resistant depression (TRD)
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| SUP 1
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| Public Citizen
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| Vol #:
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| 1
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| 2006P-0372
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| Determine whether Mepron (atovaquone) Tablets, 250 mg, has been voluntarily withdrawn from sale for safety or efficacy reasons
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| 2006V-0388
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| Projector for a Laser Light Show
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| ACK 1
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| FDA / DDM to Martin Professional Inc.
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| Vol #:
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| 1
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| VAR 1
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| Martin Professional Inc.
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| Vol #:
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| 1
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