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Dockets Management

Dockets Entered On August 13, 2007
Docket # Title
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2005N-0446 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
2006N-0211 Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Holds
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
2006P-0287 determine Whether Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily withdrawn from sale for safety or efficacy reasons
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2007D-0125 Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
2007N-0121 Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
2007N-0304 Preparation for International Conference on Harmonization Meetings in Brussels, Belgium Public Meeting
2007N-0313 Preparation for International Cooperation on Cosmetics Regulations (ICCR) Meeting in Brussels, Belgium Notice of Public Meeting
2007P-0004 Take steps to insure the safety of Americans regarding the misuses of Lasik
2007P-0074 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
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
2007P-0318 Declare that, Glucagon Hydrochloride (Glucagon) for Injection is suitable for an abbreviated new drug application (ANDA)
2007V-0319 Laser Light Show
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 838 Mission Possible International Vol #: 11
EMC 839 Mission Possible International Vol #: 11
2005N-0446 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients
C 2 Fallene Ltd. Vol #: 1
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 18334 L. Lanier Vol #: 198
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
C 18 Washington Legal Foundation Vol #: 3
LET 2 FDA Vol #: 3
LET 3 FDA Vol #: 3
LET 4 FDA Vol #: 3
2006N-0211 Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Holds
NAL 1 FDA Vol #: 1
SS 1 Supporting Statement Vol #: 1
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
C 663 V. Hess Vol #: 4
C 664 H. Behney Vol #: 4
C 665 L. Smith Vol #: 4
C 666 F. A. Carr Vol #: 4
C 667 M. Wilson Vol #: 4
C 668 A. Seymore Vol #: 4
C 669 E. Plummer Vol #: 4
C 670 M. Daubert Vol #: 4
C 671 J Broughton Vol #: 4
C 672 M. Gillis Vol #: 4
C 673 F, Jordan Vol #: 4
C 674 S. Newcomer Vol #: 4
C 675 S. Burton Vol #: 4
C 676 J. Harris Sr. Vol #: 4
C 677 J. Whiteis Vol #: 4
C 678 J. Gumerlock Vol #: 4
C 679 Wilbur K Smith Sr. Vol #: 4
C 680 F. D Straeghagon Vol #: 4
C 681 R. Howard Vol #: 4
C 682 P. Piersanti Vol #: 4
C 683 M. Kauffman Vol #: 4
C 684 R. Racinowski Vol #: 4
C 685 H. Speakman Vol #: 4
C 686 J. Smith Vol #: 4
C 687 E. Urbank Vol #: 4
C 688 A. Harding Vol #: 4
C 689 J. Pickard Vol #: 4
C 690 J. Schrensky Vol #: 4
C 691 A. Ventry Vol #: 4
C 692 J. Stewart Vol #: 4
C 693 C. Denomme Vol #: 4
C 694 J.Pinto Vol #: 4
C 695 J. Agapiou Vol #: 4
C 696 K. Curry Vol #: 4
C 697 R. Carter Vol #: 4
C 698 B. Williams Vol #: 4
C 699 A. Martin Vol #: 4
C 700 Y. Cleber Vol #: 4
C 701 S. Tishcroft Vol #: 9
C 702 R. Bates Vol #: 9
C 703 F. Craig Vol #: 9
C 704 N. McDonald Vol #: 9
C 705 M. Lewis Vol #: 9
C 706 E. Lemon Vol #: 9
C 707 L. Balya Vol #: 9
C 708 A. Epranian Vol #: 9
C 709 I King Vol #: 9
C 710 P. Houck Vol #: 9
C 711 N. Cotton Vol #: 9
C 712 S. Mauriello Vol #: 9
C 713 R. Weaver Vol #: 9
C 714 D. Raylance Vol #: 9
C 715 F. Gloger Vol #: 9
C 716 L. Butler Vol #: 9
C 717 M. Voacolo Vol #: 9
C 718 R. Kleppinger Vol #: 9
C 719 B. Vint Vol #: 9
C 720 I Ferraris Vol #: 9
C 721 F. Radler Vol #: 9
C 722 J. Huss Sr Vol #: 9
C 723 R. Ralston Vol #: 9
C 724 C. Baehne Vol #: 9
C 725 J Hoggard Vol #: 9
C 726 M. Buckley Vol #: 9
C 727 K. McGee Vol #: 9
C 728 F. Oley Vol #: 9
C 729 B. Kunkel Vol #: 9
C 730 D. Sokoloski Vol #: 9
C 731 J. Booth Sr Vol #: 4
C 732 B. Newton Vol #: 9
C 733 R. Carlson Vol #: 9
C 734 A. Kitchen Vol #: 9
C 735 H. Patts Vol #: 9
C 736 W. Warren Vol #: 9
C 737 D. Hubbard Vol #: 9
C 738 J. Sperb Vol #: 9
C 739 J. Nelson Vol #: 9
C 740 R. Sullivan Vol #: 9
C 741 S. Holzinger Vol #: 9
C 742 F. Scheirer Vol #: 9
C 743 E. Oswald Vol #: 9
C 744 D. Cirocco Vol #: 9
C 745 R. Walker Vol #: 9
C 746 C. Myszkowski Vol #: 9
C 747 D. Belling Vol #: 9
C 748 J. Steele Vol #: 9
C 749 J. Wells Vol #: 9
C 750 B. Boback Vol #: 9
C 751 R. Hickey Vol #: 9
C 752 G. McCauley Vol #: 9
C 753 O. Cieply Vol #: 9
C 754 W. Coogle Vol #: 9
C 755 E. Piccoli Vol #: 6
C 756 M. Stewart Vol #: 9
C 757 S. Taylor Vol #: 9
C 758 Joseph J Vale Vol #: 9
C 759 H. Westervelt Vol #: 9
C 760 H. Thomas Vol #: 9
C 761 E. Rolston Vol #: 9
C 762 W. Walsh Vol #: 9
C 763 L. Perkins Vol #: 9
C 764 A. Carter Vol #: 9
C 765 B. Weisensee Vol #: 9
C 766 B. Weisensee Vol #: 9
C 767 M. Meloy Vol #: 9
C 768 M. Switzer Vol #: 9
C 769 P. Farrington Vol #: 9
C 770 T. Woodman Vol #: 9
C 771 M. Russell Vol #: 9
C 772 B. Essick Vol #: 9
C 773 P. Santi Vol #: 9
C 774 E. Hexter Vol #: 6
C 775 T. Boland Vol #: 9
C 776 A. Berthiaume Vol #: 9
C 777 A. Varney Vol #: 9
C 778 R. Culleton Vol #: 9
C 779 E. Clouser Vol #: 9
C 780 V. Flick Vol #: 9
C 781 N. Kandow Vol #: 9
C 782 R. Martell Vol #: 9
C 783 C. Chapin Vol #: 9
C 784 M. Fogel Vol #: 9
C 785 D. Silver Vol #: 9
C 786 C. Bosmeny Vol #: 9
C 787 S. Jones Vol #: 9
C 788 E. Camarota Vol #: 9
C 789 C. Benson Vol #: 9
C 790 J. Bolduc Vol #: 9
C 791 E. Peach Vol #: 9
C 792 P. Swanier Vol #: 9
C 793 A. Slavik Vol #: 9
C 794 Dorothy M. Cobb Vol #: 9
C 795 M. Fleming Vol #: 9
C 796 G. Hibner Vol #: 9
C 797 A. Davis Vol #: 9
C 798 S. Rizzi Vol #: 9
C 799 M. Santiago Vol #: 9
C 800 J. Newsome Vol #: 9
C 801 G. King Vol #: 9
C 802 E.Christman Vol #: 9
C 803 P. Best Vol #: 9
C 804 M. Hastings Vol #: 9
C 805 C. Levorchick Vol #: 9
C 806 I Staebell Vol #: 9
C 807 w. Hilts Vol #: 9
C 808 J. Albany Vol #: 9
C 809 B. O'Reilly Vol #: 9
C 810 B. Crouch Vol #: 9
C 811 O. Seefried Jr. Vol #: 9
C 812 O. Henderson Vol #: 9
C 813 J. Demko Vol #: 9
C 814 E. Straight Vol #: 9
C 815 A. Horvath Vol #: 9
C 816 C. Szep Vol #: 9
C 817 J. Beursken Vol #: 9
C 818 T. Griffiths Vol #: 9
C 819 C. Osswald Vol #: 9
C 820 S. Kozlevcar Vol #: 9
C 821 R. Hoover Vol #: 9
C 822 N. Hogan Vol #: 9
C 823 E. Avers Vol #: 9
C 824 P. Ehret Vol #: 9
C 825 R. Marshall Vol #: 9
C 826 C. Banks Vol #: 9
C 827 M. Siler Vol #: 9
C 828 E. Farley Vol #: 9
C 829 B. Jones Vol #: 9
C 830 D. Muckler Vol #: 9
C 831 E. Gatschet Vol #: 9
C 832 W. Cottrell Vol #: 9
C 833 D. Ponteso Vol #: 9
C 834 K. Greens Vol #: 9
C 835 M. LaMarche Vol #: 9
C 836 W. Shea Vol #: 9
C 837 J. Juanson Vol #: 9
C 838 S. Reed Vol #: 9
C 839 D. Panessa Vol #: 9
C 840 Nancy C. Eddy Vol #: 9
C 841 T. Somers Vol #: 9
C 842 C. Hendrickson Vol #: 9
C 843 J. Loughlin Vol #: 9
C 844 B. Miller Vol #: 9
C 845 K Carpenter Vol #: 9
C 846 C. MacGillivray Vol #: 9
C 847 D. Graff Vol #: 9
C 848 C. Garlick Vol #: 9
C 849 E. Schielke Vol #: 9
C 850 M. Whalen Vol #: 9
2006P-0287 determine Whether Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily withdrawn from sale for safety or efficacy reasons
LET 2 Nikki Mueller Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 129 Patrizia Mauti Busby Vol #: 7
2007D-0125 Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
EXT 2 Consumer Healthcare Products Association (CHPA) Vol #: 1
2007N-0121 Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
C 11 Consumer Drug Information Group Vol #: 7
2007N-0304 Preparation for International Conference on Harmonization Meetings in Brussels, Belgium Public Meeting
NM 1 FDA Vol #: 1
2007N-0313 Preparation for International Cooperation on Cosmetics Regulations (ICCR) Meeting in Brussels, Belgium Notice of Public Meeting
NM 1 FDA Vol #: 1
2007P-0004 Take steps to insure the safety of Americans regarding the misuses of Lasik
EMC 6 Dean Kantis Vol #: 1
2007P-0074 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
LET 5 FDA/Division of Nonprescription Clinical Evaluation to Errol Alden, M.D. Vol #: 1
LET 6 FDA/ Division of Nonprescrition Clinical Evaluation to Bruce Anderson, Pharm.D. Vol #: 1
LET 7 FDA/Divison Nonprescription Clinical Evaluation to Douglas E. Henley, M.D. Vol #: 1
LET 8 FDA/ Divison of Nonprescription Clinical Evaluation to David Fowler, M.D Vol #: 1
LET 9 FDA/Divison of Nonprescription Clinical Evaluation to Heinz Schneider, DR. Med. Vol #: 1
LET 10 FDA/Divison of Nonprescription Clinical Evaluation to Dean Wilkerson, MBA, JD, CAE Vol #: 1
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
C 187 Ilse Berkley Vol #: 6
C 188 Bobby Gleason Vol #: 6
C 189 Paul Mast Vol #: 6
C 190 Melissa R. Crick Vol #: 6
C 191 Neida Rodriguez Vol #: 6
C 192 Healther Breo Vol #: 6
C 193 Unknown Vol #: 6
C 194 Patricia White Vol #: 6
C 195 Barry S. Rigg Vol #: 6
C 196 Sylvia Paredes Vol #: 6
C 197 Teresa F. Morin Vol #: 6
C 198 Katie Parris Vol #: 6
C 199 Gregory Stula Vol #: 6
C 200 Steve and Cheryl Lee Vol #: 6
C 201 Patrick Coady Vol #: 6
C 202 Kathleen M. Dickinson Vol #: 6
C 203 Susan Fewkes Vol #: 6
C 204 Donna Stewart Vol #: 6
C 205 Aimee Montgomery Vol #: 6
C 206 Christine M. Sisson Vol #: 6
C 207 G. Bowen Vol #: 6
C 208 Juli Burroughs Vol #: 6
C 209 TriNET, Inc. Vol #: 6
C 210 Unknown Vol #: 6
C 211 Steve Smith Vol #: 6
C 212 Melissa R Vol #: 6
C 213 John McDonald & Jaimie Trematore Vol #: 6
C 214 Michael J. Gorga Vol #: 6
C 215 Renata Weber Vol #: 6
C 216 Amber Lubeck Vol #: 6
C 217 Barbara J. Linn Vol #: 6
C 218 Catherine Anne Beck Vol #: 6
C 219 Norma I. Herrington Vol #: 6
2007P-0318 Declare that, Glucagon Hydrochloride (Glucagon) for Injection is suitable for an abbreviated new drug application (ANDA)
ACK 1 FDA/DDM to Cornerstone Regulatory Vol #: 1
CP 1 Cornerstone Regulatory Vol #: 1
2007V-0319 Laser Light Show
ACK 1 FDA /DDM / to Geller Laser Vol #: 1
VAR 1 Geller Vol #: 1

Page created on August 28, 2007 ue

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