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| Dockets Management
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| Dockets Entered On
June 21, 2006
Table of Contents
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 1980N-0280
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| Vaginal Contraceptive Drug Products for OTC Use
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004E-0396
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| Patent Extension for TAXUS EXPRESS (Paclitaxel-Eluting Coronary Stent System)
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| 2004P-0417
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| ANDA Doryx (coated doxycycline hyclate pellets) in powder or other fill present
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| 2005E-0236
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| Patent Extension Application for MULTIHANCE (gadobenate dimeglumine), U.S. Patent No. 4,912,246
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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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-0501
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| Revise FDA's guidance entitled labeling for combined oral contraeceptives so that the labels of combined oral contraceptives have warnings relating to the risk of thromboembolic disease
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| 2006E-0004
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| Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
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| 2006E-0189
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| Patent Extension Application for IPLEX (mecasermin rinfabate rDNA origin injection), U.S. Patent No. 5,681,818
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| 2006E-0260
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| Patent Extension Application for ORENCIA (abatacept), U.S. Patent No. 5,851,795
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| 2006E-0261
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| Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| 2006N-0109
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| General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities
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| 2006P-0135
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| Issue Guidance to Industry outlining procedures and standards for initiating an 'expanded access program' for unapproved drugs
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| 2006P-0154
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| remove from the market, the prescription version of Xenical (orlistat,Roche Pharmaceuticals)
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| 2006P-0205
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| Require Vitamin D be added to cereal-grain products
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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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| swith 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 because of
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| 2006P-0245
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| Exclusivity Determination for Risperidone
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| 2006P-0263
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| ANADA suitability for Neomycin
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| 1978N-0038
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| Sunscreen Drug Products
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| SUP 34
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| International Center for Technology Assessment
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| Vol #:
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| 150
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| 1980N-0280
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| Vaginal Contraceptive Drug Products for OTC Use
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| LET 8
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| FDA
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| Vol #:
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| 12
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| C 102
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| Honorable Russell D. Feingold
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| Vol #:
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| 28
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| LET 3
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| FDA to Honorable Russell D. Feingold
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| Vol #:
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| 28
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| GDL 2
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| Guidance
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| 15
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| NAD 2
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| FDA
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| Vol #:
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| 15
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| SS 1
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| Suporting Statement
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| Vol #:
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| 15
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| 2004E-0396
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| Patent Extension for TAXUS EXPRESS (Paclitaxel-Eluting Coronary Stent System)
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| LET 4
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| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2004P-0417
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| ANDA Doryx (coated doxycycline hyclate pellets) in powder or other fill present
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| WDL 1
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| Warner Chilcott Inc.
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| Vol #:
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| 2
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| 2005E-0236
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| Patent Extension Application for MULTIHANCE (gadobenate dimeglumine), U.S. Patent No. 4,912,246
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| LET 4
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| 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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| MO 13
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| FDA/CDRH/OGC
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| Vol #:
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| 3
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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| EXT 1
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| Compressed Gas Association (CGA) and Gases and Welding Distributors Association (GAWDA)
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 13489
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| A. Greenwood
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| Vol #:
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| 156
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| C 13490
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| T. Branstner
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| Vol #:
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| 156
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| C 13491
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| R. H. Hill
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| Vol #:
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| 156
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| C 13492
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| J. Ellingsen
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| Vol #:
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| 156
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| 2005P-0501
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| Revise FDA's guidance entitled labeling for combined oral contraeceptives so that the labels of combined oral contraceptives have warnings relating to the risk of thromboembolic disease
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| LET 1
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| FDA/CDER to Hyman, Phelps & McNamara, P.C
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| Vol #:
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| 1
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| 2006E-0004
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| Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
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| LET 3
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0189
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| Patent Extension Application for IPLEX (mecasermin rinfabate rDNA origin injection), U.S. Patent No. 5,681,818
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| LET 3
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0260
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| Patent Extension Application for ORENCIA (abatacept), U.S. Patent No. 5,851,795
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| APP 1
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| Bristol-Myers Squibb Company
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| Vol #:
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| 1
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| LET 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0261
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| Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
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| APP 1
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| Novartis
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| Vol #:
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| 1
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| LET 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| MM 1
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| May 11, 2006 Meeting Summary
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| Vol #:
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| 2
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| TR 1
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| Transcript May 11, 2006 Workshop
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| Vol #:
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| 3
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| 2006N-0109
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| General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities
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| C 1
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| G. Scott, PhD
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| Vol #:
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| 1
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| 2006P-0135
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| Issue Guidance to Industry outlining procedures and standards for initiating an 'expanded access program' for unapproved drugs
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| C 1
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| Cancer Leadership Council (CLC)
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| Vol #:
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| 1
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| 2006P-0154
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| remove from the market, the prescription version of Xenical (orlistat,Roche Pharmaceuticals)
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| SUP 2
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| Public Citizen
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| Vol #:
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| 2
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| 2006P-0205
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| Require Vitamin D be added to cereal-grain products
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| C 1
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| R. Recker, M.D., M.A.C.P., F.A.C.E.
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| Vol #:
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| 2
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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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| SUP 1
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| International Center for Technology Assessment (CTA)
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| Vol #:
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| 3
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| 2006P-0223
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| swith 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 because of
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| LET 1
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| State of Wisconsin Department of Justic
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| Vol #:
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| 1
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| 2006P-0245
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| Exclusivity Determination for Risperidone
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0263
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| ANADA suitability for Neomycin
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| ACK 1
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| FDA/ DDM to Sparhawk Laboratories, Inc
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| Vol #:
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| 1
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| CP 1
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| Sparhawk Laboratories, Inc
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| Vol #:
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| 1
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