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Dockets Management

Dockets Entered On January 26, 2007
Docket # Title
1978N-0065 Skin Bleaching Drug Products
2003N-0573 Draft Animal Cloning Risk Assessment
2004P-0464 Vitamin D & Calcium & Reduced Risk of Osteoporosis
2005D-0348 Guidance for Industry and Food and Drug Administration: Procedures for Handling Post-Approval Studies Imposed by PMA Order
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2005N-0373 Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
2006D-0353 Guidance for Industry and FDA Staff: Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
2006D-0400 Global Harmonization Task Force, Study Groups 1, 2, 4, and 5; New Proposed and Final Documents; Availability
2006D-0408 Guidance for Industry and Food and Drug Administration Staff; Annual Reports for Approved Premarket Approval Applications
2006D-0463 Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability
2006D-0514 Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
2006E-0332 Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,061,703
2006E-0333 Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,614,560
2006E-0516 Patent Extension Application for SPRYCEL (dasatinib), U.S. Patent No. 6,596,746
2006M-0293 P050044 - Vitagel Surgical Hemostat
2006M-0294 P050017 - Zilver Vascular Stent
2006M-0295 P050014 - Fuji Computed Radiography Mammography Suite (FCRMS)
2006M-0321 P050051 - ARCHITECT AUSAB Reagent Kit, ARCHITECT AUSAB Calibrators, and ARCHITECT AUSAB Controls
2006M-0322 P050011 - Adept (4% Icodextrin) Adhesion Reduction Solution
2006M-0323 P970043/S020 - LADARVision 4000 Excimer Laser System and the LADAR 6000 Excimer Laser System
2006M-0324 P970043/S022 - LADARVision 4000 Excimer Laser System and the LADAR 6000 Excimer Laser System
2006M-0325 P020050/S004 - WaveLight ALLEGRETTO WAVE Excimer Laser System
2006M-0338 P010029 - Nuflexxa (1% Sodium Hyaluronate)
2006M-0339 P030019 - ORTHOVISC High Molecular Weight Hyaluronan
2006M-0340 P030016 - Visian ICL (Implantable Collamer Lens)
2006M-0341 P050006 - GORE HELEX Septal Occluder
2006M-0342 P060004 - MEL 80 Excimer Laser System
2006M-0343 P050010 - PRODISC-L Total Disc Replacement
2006M-0367 P050023 - Tupos LV/ATx CRT-D, Kronos LV-T CRT-D, 505.U Programmer Software for the ICS 3000, A-K00.7.U Programmer Software for the EPR/TMS 1000PLUS and Corox OTW Steroid Lead
2006M-0368 H040006 - AbioCor Implantable Replacement Heart
2006M-0374 P040036 - Navistar ThermoCool Deflectable Diagnostic/Ablation Catheter
2006M-0389 P050042 - ARCHITECT Anti-HCV Assay; ARCHITECT Anti-HCV Calibrator and ARCHITECT Anti-HCV Control
2006N-0062 Expanded Access to Investigational Drugs for Treatment Use
2006N-0279 Agency Information Collection Activities: Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products
2006N-0525 Supplements and Other Changes to an Approved Application
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0415 Petition Seeking Regulation of Cloned Animals
2006P-0535 Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
2007D-0017 Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnost
2007E-0010 Patent Extension Application for Chantix (varenicline), U.S. Patent No. 6,410,550
2007E-0011 Patent Extension Application for Lantus (insulin glargine rDNA origin), U.S. Patent No. 5,101,013
2007N-0014 Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), and GRAS Affirmation; Electronic Submission
2007N-0015 Agency Information Collection Activities; Proposed Collection; Comment Request; Adoption of the FDA Food Code by Local, State, and Tribal Governments
2007N-0018 Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Form FDA 3356; El
1978N-0065 Skin Bleaching Drug Products
EC 610 Mrs. debbie Creel Vol #: 19
EC 611 Miss. Monica Em Vol #: 19
EC 612 Mrs. Brenda Barrelle Vol #: 19
EC 613 Mrs. Sandra Hernandez Vol #: 19
EC 614 Mrs. Bobbie McKinney Vol #: 19
EC 615 Mrs. alicia ortiz Vol #: 19
EC 616 Steinberg Vol #: 19
EC 617 Dr. L:M Houston Vol #: 19
EC 618 Mr. M Morris Vol #: 19
EC 619 Truett Laboratories Vol #: 19
EC 620 Dermatology Clin Assoc Vol #: 19
2003N-0573 Draft Animal Cloning Risk Assessment
EC 2643 Mr. Robert Tribbie Vol #: 15
EC 2644 Ms. Melissa Morrone Vol #: 15
EC 2645 Ms. Nadine Pourier Vol #: 15
EC 2646 Mr. Gregory King Vol #: 15
EC 2647 Mrs. Jessica Kuwata Vol #: 15
EC 2648 none Vol #: 15
EC 2649 Mrs. L. Taylor Vol #: 15
EC 2650 Mrs. Donna Lueck Vol #: 15
EC 2651 MIT Vol #: 15
EC 2652 Ms. Kieron Torres Vol #: 15
EC 2653 Today's Chiropractic Vol #: 15
EC 2654 Ms. M. L. Theeman Vol #: 15
EC 2655 Mrs. Lena Hahn-Schuman Vol #: 15
EC 2656 Mrs. Janet Whitty Vol #: 15
EC 2657 Mrs. Cher Underwood Forsberg Vol #: 15
EC 2658 Mrs. Michelle Evans Vol #: 15
EC 2659 Ms. Kim Holmes Vol #: 15
EC 2660 Miss. Hailey Daigle Vol #: 15
EC 2661 Mrs. Esther Howard Vol #: 15
EC 2662 Ms. Aria Benner Vol #: 15
EC 2663 Mrs. Cherie Borgia Vol #: 15
EC 2664 Mr. Michael Cepuch Vol #: 15
EC 2665 Invincible Crazy Fists Vol #: 15
EC 2666 Ms. Bridget Stuchly Vol #: 15
EC 2667 Mr. Sam Leopold Vol #: 15
EC 2668 Mrs. Tara Schaller Vol #: 15
EC 2669 Ms. Alicia Jones Vol #: 15
EC 2670 Ms. Mary Ann Holtz Vol #: 15
EC 2671 Mr. Jeff Howe Vol #: 15
EC 2672 Ms. Jill Weitz Vol #: 15
EC 2673 Mr. Dinko Matkovic Vol #: 15
EC 2674 Mrs. Melissa Frantz Vol #: 15
EC 2675 Miss. k j Vol #: 15
EC 2676 Mr. Rodney Schiffbauer Vol #: 15
EC 2677 Mrs. Ann Kelly Vol #: 15
EC 2678 Miss. severine calcagni Vol #: 15
EC 2679 Ms. Karen Bowers Vol #: 15
EC 2680 Mrs. Crystal Castillo Vol #: 15
EC 2681 Mrs. Barbara Fairbanks Vol #: 15
EC 2682 Ms. Claudia Castano Vol #: 15
EC 2683 Dr. Barbara Molette Vol #: 15
EC 2684 Mrs. Cheri Case Vol #: 15
EC 2685 Ms. Rasheeda Austin Vol #: 15
EC 2686 Ms. carol roffe Vol #: 15
EC 2687 Ms. Sara Becker Vol #: 15
EC 2688 Ladybug Organic Coffee Company Vol #: 15
EC 2689 Mrs. Carson Smith Vol #: 15
EC 2690 Ms. Janet Draper Vol #: 15
EC 2691 Ms. Veronica Boyd Vol #: 15
EC 2692 Mrs. Shellie Lowe Vol #: 15
EC 2693 Mr. whittaker alastair Vol #: 15
EC 2694 Jacques Gourmet Vol #: 15
EC 2695 Mrs. Ellen Brown Vol #: 15
EC 2696 General public Vol #: 15
EC 2697 Dr. jonathan Arias Vol #: 15
EC 2698 Mrs. Lisa Cowdrey Vol #: 15
EC 2699 Mr. michael gwoah Vol #: 15
EC 2700 Mr. Dana Rothrock Vol #: 15
EC 2701 Mrs. Jodi VanderSloot Vol #: 15
EC 2702 Mr. Kerry Foster Vol #: 15
EC 2703 Ms. Terry Emerson Vol #: 15
EC 2704 none Vol #: 15
EC 2705 Ms. Virginia Carabelli Vol #: 15
EC 2706 Ms. Jennifer Sullivan Vol #: 15
EC 2707 Ms. Gohar Grigoryan Vol #: 15
EC 2708 Mr. Deven Shah Vol #: 15
EC 2709 Mrs. Lisa Bond Vol #: 15
EC 2710 Ms. Laura Cheney Vol #: 15
EC 2711 Mrs. Taysia Mitton Vol #: 15
EC 2712 Mrs. Kathleen Schmidt Vol #: 15
EC 2713 Ms. Dorothy McCauley Vol #: 15
EC 2714 Mr. K Flynn Vol #: 15
EC 2715 Ms. GWEN KAISER Vol #: 15
EC 2716 Ms. Debra Tharnish Vol #: 15
EC 2717 Mrs. Diane Daigle Vol #: 15
EC 2718 Mrs. Lydia Jones Vol #: 15
EC 2719 Mr. Odie Lindsey Vol #: 15
EC 2720 Mrs. Sheila Cullers Vol #: 15
EC 2721 UNEMPLOYED Vol #: 15
EC 2722 Mr. Ron Miller Vol #: 15
EC 2723 Ms. Courtney Ruane Vol #: 15
EC 2724 Ms. S. Rene' Hardman Vol #: 15
EC 2725 Mrs. Estreitta Martin de Kluetz Vol #: 15
EC 2726 Mr. Albert Gregoritsch Vol #: 15
EC 2727 personal consumer Vol #: 15
EC 2728 Mrs. Heather Lauer Vol #: 15
EC 2729 Miss. amanda Barrett Vol #: 15
EC 2730 personal Vol #: 15
EC 2731 Miss. abby dewald Vol #: 15
EC 2732 Mr. William Ryder Vol #: 15
EC 2733 Ms. Jill Salamunovich Vol #: 15
EC 2734 Ms. Vanda Osmon Vol #: 15
EC 2735 Miss. Negar Nasoohi Vol #: 15
EC 2736 Mrs. Aliece Gearhart Vol #: 15
EC 2737 Mr. Sergio Nevel Vol #: 15
EC 2738 NA Vol #: 15
EC 2739 Ms. Cindy McDaniel Vol #: 15
EC 2740 Mr. David Cullers Vol #: 15
EC 2741 Ms. Suellen Rust Vol #: 15
EC 2742 NCNM Vol #: 15
EC 2743 Ms. Bec Kemp Vol #: 15
EC 2744 Mrs. Michelle Redmond Vol #: 15
EC 2745 Ms. Melanie Pederson-Scholz Vol #: 15
EC 2746 Ms. Kathy McLean Vol #: 15
EC 2747 Mr. Emmet Mcpherson Vol #: 15
EC 2748 Mrs. pam noonan Vol #: 15
EC 2749 Ms. Livnat Lotati Vol #: 15
EC 2750 Mr. Cary Cook Vol #: 15
EC 2751 Mrs. Henrietta Shafer Vol #: 15
EC 2752 Mr. Ted Redmond Vol #: 15
EC 2753 Mr. Donald Ryder Vol #: 15
EC 2754 Mr. Ketil Jensen Vol #: 15
EC 2755 Ms. Melva Ryan Vol #: 15
EC 2756 Mrs. Cheryl Skynar Vol #: 15
EC 2757 Mrs. Nicole Zapinski Vol #: 15
EC 2758 Ms. Karina Forberger Vol #: 15
EC 2759 Ms. Lori Roush Vol #: 15
EC 2760 Mrs. Marilyn Self Vol #: 15
EC 2761 Mrs. patrice williams Vol #: 15
EC 2762 Mrs. Joy Sutherland Vol #: 15
EC 2763 Mr. Phillip C'de Baca Vol #: 15
EC 2764 Mr. Nicholas Etchart Vol #: 15
EC 2765 Ms. Marla Bottesch Vol #: 15
EC 2766 Ms. Julia Gagliardi Vol #: 15
EC 2767 Mr. John Kittlaus Vol #: 15
EC 2768 Mrs. Maria Wiley Vol #: 15
EC 2769 Ms. Dawn DiPersio Vol #: 15
EC 2770 Mrs. Christine Hannon Vol #: 15
EC 2771 Mr. MICHAEL WILEY Vol #: 15
EC 2772 Mr. Corey Taylor Vol #: 15
EC 2773 Mrs. Neta Norman Vol #: 15
EC 2774 Mrs. Pamela Morgan Vol #: 15
EC 2775 Ms. Goldie Caughlan Vol #: 15
EC 2776 Mr. Nicholas Gullo Vol #: 15
EC 2777 Mrs. Valerie Henderson Vol #: 15
EC 2778 Ms. MarLynn Blackwell Vol #: 15
EC 2779 Mrs. Annie Jones Vol #: 15
EC 2780 Mr. John Karbowski Vol #: 15
EC 2781 Ms. Amber Good Vol #: 15
EC 2782 Ms. Nicole Masika Vol #: 15
EC 2783 Mrs. Karan Clarke Vol #: 15
EC 2784 Ms. Yegana Mehdi Vol #: 15
EC 2785 Ms. Meghan Woods Vol #: 15
EC 2786 Dr. Hesh Goldstein Vol #: 15
EC 2787 Mrs. Leslie Brush Vol #: 15
EC 2788 n/a Vol #: 15
EC 2789 Mr. Paul Hoover Vol #: 15
EC 2790 Ms. Anna Stuart Vol #: 15
EC 2791 Integrated Medicine of Miami-Dade Vol #: 15
EC 2792 Ms. Robin Howell Vol #: 15
EC 2793 Ms. Jacqueline Remington Vol #: 15
EC 2794 Mrs. Patty Bostick Vol #: 15
EC 2795 Ms. Cynthia Stone Vol #: 15
EC 2796 Mr. Andrew Malles Vol #: 15
EC 2797 People's Food Cooperative Vol #: 15
EC 2798 Mrs. Lauretta Rion Vol #: 15
EC 2799 N/A Vol #: 15
EC 2800 Rowan-Cabarrus Comm. College (Business Law) Vol #: 15
EC 2801 Rowan Cabarrus Community College Vol #: 15
EC 2802 Ms. ellen hyatt Vol #: 15
EC 2803 Ms. lisa kohanski Vol #: 15
EC 2804 Mrs. Mary Summa Vol #: 15
EC 2805 Ms. Candace Cox Vol #: 15
EC 2806 Mrs. Nicole Neatherlin Vol #: 15
EC 2807 Ms. S Sword Vol #: 15
EC 2808 Miss. Leah Ingram Vol #: 15
EC 2809 Mrs. Tammy Moore Vol #: 15
EC 2810 Mrs. Tammy Moore Vol #: 15
EC 2811 Mr. Daniel Neghassi Vol #: 15
EC 2812 Mrs. Bonnie Resetar Vol #: 15
EC 2813 Ms. Sharon Thompson Vol #: 15
EC 2814 Mrs. Laura Heins Vol #: 15
EC 2815 Ms. Nancy Pulone Vol #: 15
EC 2816 Mrs. Carolyn Bauer Vol #: 15
EC 2817 Ms. Angela Moncrief Vol #: 15
EC 2818 Mr. Donny Allen Vol #: 15
EC 2819 American Federation of Musicians Vol #: 15
EC 2820 Mr. M. Preston Vol #: 15
EC 2821 Mrs. velvet schambacher Vol #: 15
EC 2822 Mrs. Nora Orozco Vol #: 15
EC 2823 Mr. Russell Sporleder Vol #: 15
EC 2824 Mrs. karen hadley Vol #: 15
EC 2825 Ms. Kimberley Smith Vol #: 15
EC 2826 Miss. Bonnie MacDonald Vol #: 15
EC 2827 none Vol #: 15
EC 2828 Mrs. Jessica Lucas Vol #: 15
EC 2829 Ms. Kesi Rentie Vol #: 15
EC 2830 Mrs. chris myers Vol #: 15
EC 2831 Mrs. Sharla Hobbs Vol #: 15
EC 2832 Mr. James Felts Vol #: 15
EC 2833 Ms. Melissa Satterwhite Vol #: 15
EC 2834 Ms. Diane Hain Vol #: 15
EC 2835 Ms. Piper Fogle Vol #: 15
EC 2836 Mrs. Sherry Longo Vol #: 15
EC 2837 Mrs. Cristina Murphy Vol #: 15
EC 2838 Miss. Rebecca Johnson Vol #: 15
EC 2839 Ms. Adrienne Vincent Sutton Vol #: 15
EC 2840 Mr. Nick W Vol #: 15
EC 2841 Mrs. Jennifer Chester Vol #: 15
EC 2842 Mrs. Bambi Wheale Vol #: 15
EC 2843 Mrs. Linda Schier Vol #: 15
EC 2844 Ms. Susan Boucher Vol #: 15
EC 2845 Mrs. Monica Stevens Vol #: 15
EC 2846 Mrs. Laura Blair Vol #: 15
EC 2847 US Citizen and Tax Payer Vol #: 15
EC 2848 Mrs. Carolyn Boyle Vol #: 15
EC 2849 Nutrition Therapist Vol #: 15
EC 2850 Ms. Joanna Baskett Vol #: 15
EC 2851 Mr. David Michael Vol #: 15
EC 2852 Ms. margaret g. brown Vol #: 15
EC 2853 Mrs. SUZY BOATRIGHT Vol #: 15
EC 2854 Ms. Robin Appel Vol #: 15
EC 2855 Mrs. Olivia Frison-Kent Vol #: 15
EC 2856 Mr. Jyrell Keys Vol #: 15
EC 2857 Miss. L Brown Vol #: 15
EC 2858 Mrs. wencke muhlenberg Vol #: 15
EC 2859 Mrs. Stephanie Rosier Vol #: 15
EC 2860 Ms. Mark Walker Vol #: 15
EC 2861 Ms. Heidi Warren Vol #: 15
EC 2862 Dr. Clair Anderson Vol #: 15
EC 2863 Ms. Kimberley Shuler Vol #: 15
EC 2864 Ms. serena van vranken Vol #: 15
EC 2865 Mr. Jason Papadopoulos Vol #: 15
EC 2866 Mr. Thomas Davidson Vol #: 15
EC 2867 Mr. Roger Merritt Vol #: 15
EC 2868 Mr. Jose Lozano Vol #: 15
EC 2869 Mr. J Kehr Vol #: 15
EC 2870 Mr. Thomas Vogl Vol #: 15
EC 2871 Ms. Jolita Jarmakauskiene Vol #: 15
EC 2872 Personal Vol #: 15
EC 2873 Miss. Nancy Powers Vol #: 15
EC 2874 Ms. Ellen Lee Vol #: 15
EC 2875 Ms. Sjonia Harper Vol #: 15
EC 2876 N/A Vol #: 15
EC 2877 Ms. VT Dean Vol #: 15
EC 2878 none Vol #: 15
EC 2879 Ms. Lisa Knoblauch Vol #: 15
EC 2880 Mrs. Jennifer Hartswick Vol #: 15
EC 2881 Mrs. Linda Schneider Vol #: 15
EC 2882 Ms. Lara Leimbach Vol #: 15
EC 2883 none Vol #: 15
EC 2884 Mr. Markus Houston Vol #: 15
EC 2885 Mrs. Martha McCormick Vol #: 15
EC 2886 Ms. Tanja Beck Vol #: 15
EC 2887 Mrs. Dorothy Petraitis Vol #: 15
EC 2888 NA Vol #: 15
EC 2889 Mrs. Nancy Hamlet Vol #: 15
EC 2890 Ms. Tia Roebuck Vol #: 15
EC 2891 american deeply concerned Vol #: 15
EC 2892 Mrs. V Briscoe Vol #: 15
EC 2893 Dr. tami youngman Vol #: 15
EC 2894 Mr. David Estes Vol #: 15
EC 2895 Mrs. Lori Byron Vol #: 15
EC 2896 Ms. Lisa Zywicki Vol #: 15
EC 2897 Mrs. Melissa Pilkington Vol #: 15
EC 2898 Mrs. Heather Turzak Vol #: 15
EC 2899 Mrs. Susan Cunningham Vol #: 15
EC 2900 Ms. Patricia Sweeney Vol #: 15
EC 2901 Ms. Carla Roethlisberger Vol #: 17
EC 2902 Ms. Yvonne Gonski Vol #: 17
EC 2903 Ms. Judith Ginter Vol #: 17
EC 2904 Mr. Terry Qualls Vol #: 17
EC 2905 Ms. Lois Gardner Vol #: 17
EC 2906 Mrs. Joyce Roberts Vol #: 17
EC 2907 Miss. Cuyler Burke Vol #: 17
EC 2908 Ms. Mary Myers Vol #: 17
EC 2909 Ms. Kristi Fletcher Vol #: 17
EC 2910 Mrs. Venus Chaney Vol #: 17
EC 2911 Mr. Nicolae Popescu Vol #: 17
EC 2912 Ms. Akilah Kweli Vol #: 17
EC 2913 Ms. Marguerite Campbell Vol #: 17
EC 2914 Ms. Janet Sperberg Vol #: 17
EC 2915 Miss. Jessica Cheung Vol #: 17
EC 2916 Mr. H Melancon Vol #: 17
EC 2917 Rally Sport Health Vol #: 17
EC 2918 Mrs. Lynette Mirrielees Vol #: 17
EC 2919 Ms. Michelle Newman Vol #: 17
EC 2920 Ms. Michelle Newman Vol #: 17
EC 2921 Miss. Aida Velazquez Vol #: 17
EC 2922 Ms. Maria Montargil Vol #: 17
EC 2923 Mr. Merius Atangcho Vol #: 17
EC 2924 Ms. Dorothy Swinton Vol #: 17
EC 2925 Ms. Carolyn Greene Vol #: 17
EC 2926 Mrs. WANDA DANIEL Vol #: 17
EC 2927 Ms. Cleta Johnson Vol #: 17
EC 2928 Ms. Jessica Garrels Vol #: 17
EC 2929 Ms. June Johnson Vol #: 17
EC 2930 Ms. Mary LaRue Vol #: 17
EC 2931 Mrs. Shirley Gaubatz Vol #: 17
EC 2932 Mrs. Melinda Thayer Vol #: 17
EC 2933 Ms. H Wilson Vol #: 17
EC 2934 Mrs. kristina womack Vol #: 17
EC 2935 Ms. Patti Harris Vol #: 17
EC 2936 Ms. Tonya Rivera Vol #: 17
EC 2937 Mrs. Susan Taylor Vol #: 17
EC 2938 Ms. Kelly Moore Vol #: 17
EC 2939 Mr. Mike Burgess Vol #: 17
EC 2940 Mrs. Danyelle Crum Vol #: 17
EC 2941 Ms. Meghan Arnold Vol #: 17
EC 2942 Mrs. Anonymous Anonymous Vol #: 17
EC 2943 Mr. Anthony Correa Vol #: 17
EC 2944 Mrs. Barbara Jacobson Vol #: 17
EC 2945 Mrs. Judy Metz Vol #: 17
EC 2946 Mr. Brad Rubenstein Vol #: 17
EC 2947 Mrs. Emily Dixon Vol #: 17
EC 2948 Ms. Joanne Rich Vol #: 17
EC 2949 Mr. Bart van Belle Vol #: 17
EC 2950 Ms. Stephanie King Vol #: 17
EC 2951 Ms. Mary Stock Vol #: 17
EC 2952 Ms. Susan Gegan Vol #: 17
EC 2953 Mrs. Jeanne Young Vol #: 17
EC 2954 Mr. Brian Fox Vol #: 17
EC 2955 Ms. Melissa Fontes Vol #: 17
EC 2956 Mr. Kevin Ball Vol #: 17
EC 2957 Mrs. Cynthia Robicheaux Vol #: 17
EC 2958 Mrs. Dana Pittman Vol #: 17
EC 2959 Ms. Mary Jokela Vol #: 17
EC 2960 Ms. Cidny Tebo Vol #: 17
EC 2961 Mr. CRAIG T---- Vol #: 17
EC 2962 Mr. Aaron Spoolstra Vol #: 17
EC 2963 Mrs. Rosemary Taft Vol #: 17
EC 2964 Ms. Y Briscoe Vol #: 17
EC 2965 Mrs. Viola Jaynes Vol #: 17
EC 2966 Miss. Sharon Wineinger Vol #: 17
EC 2967 Mrs. joan churchill Vol #: 17
EC 2968 Dr. Jason Holt Vol #: 17
EC 2969 Miss. Whitney Cato Vol #: 17
EC 2970 Mr. Zachary Porter Vol #: 17
EC 2971 Miss. Lynsey Underwood Vol #: 17
EC 2972 Miss. Taylor Holt Vol #: 17
EC 2973 Ms. megan whitten Vol #: 17
EC 2974 Mr. Alex Powell Vol #: 17
EC 2975 Mr. Daniel Kilpatric Vol #: 17
EC 2976 Mr. Joshua Malone Vol #: 17
EC 2977 Mr. jerimiah thurman Vol #: 17
EC 2978 Miss. Caroline Dunn Vol #: 17
EC 2979 Miss. Maggie Gleason Vol #: 17
EC 2980 Mr. chase diaz Vol #: 17
EC 2981 Mr. devonte whitfield Vol #: 17
EC 2982 Mrs. Bethany Libenson Vol #: 17
EC 2983 Miss. Brittany Brown Vol #: 17
EC 2984 Miss. angel grigsby Vol #: 17
EC 2985 Mr. Josh Freeman Vol #: 17
EC 2986 Mr. Derrick Hood Vol #: 17
EC 2987 Mr. Karrington Gholston Vol #: 17
EC 2988 Mr. Eduardo Boleaga Vol #: 17
EC 2989 Mr. Ivan Montalvo Vol #: 17
EC 2990 Mr. alex wilson Vol #: 17
EC 2991 Mr. Miguel Barrientos Vol #: 17
EC 2992 Mr. Rashadis Nicholson Vol #: 17
EC 2993 Mr. chase grisham Vol #: 17
EC 2994 Mr. Nestor Barrueta Vol #: 17
EC 2995 Mr. BOBBY THOMAS Vol #: 17
EC 2996 Miss. Briana Fagan Vol #: 17
EC 2997 Mr. Henry Krueger Vol #: 17
EC 2998 Mr. max smith Vol #: 17
EC 2999 Mr. Bryant Hardison Vol #: 17
EC 3000 Dr. JOANNA KIRKPATRICK, PHD Vol #: 17
EC 3001 Dr. JOANNA KIRKPATRICK, PHD Vol #: 17
EC 3002 Mr. Alex Watkins Vol #: 17
EC 3003 Miss. Janelle Wallace Vol #: 17
EC 3004 Miss. Kathryn Harris Vol #: 17
EC 3005 Miss. Elizabeth Zagal Vol #: 17
EC 3006 Mr. Cody Terry Vol #: 17
EC 3007 Mr. joshua bryant Vol #: 17
EC 3008 Ms. Brooke Ratliff Vol #: 17
EC 3009 Miss. Amber Vinson Vol #: 17
EC 3010 Miss. Aundrea Dortch Vol #: 17
EC 3011 Mr. kyle stripe Vol #: 17
EC 3012 Miss. ashley chidlers Vol #: 17
EC 3013 Miss. Alexis Williams Vol #: 17
EC 3014 Miss. Carlie Parker Vol #: 17
EC 3015 Ms. Dylan Humphries Vol #: 17
EC 3016 Miss. columba valdez Vol #: 17
EC 3017 Mr. Hunter Spivey Vol #: 17
EC 3018 Mr. zach richie Vol #: 17
EC 3019 Ms. Christine Lamkin Vol #: 17
EC 3020 Mr. chris emerson Vol #: 17
EC 3021 Mr. Jimmy Dunahoo Vol #: 17
EC 3022 Miss. Stephanie Moore Vol #: 17
EC 3023 Miss. Breana Rochelle Vol #: 17
EC 3024 Miss. Graciela Juan Vol #: 17
EC 3025 Mr. kENNETH tHRONEBERRY Vol #: 17
EC 3026 Miss. Tonya Stout Vol #: 17
EC 3027 Mr. Jose Diez Vol #: 17
EC 3028 Mr. Corey Lindsey Vol #: 17
EC 3029 Mr. Josh Colbert Vol #: 17
EC 3030 Mr. tyree gamble Vol #: 17
EC 3031 Mr. moises vazquez Vol #: 17
EC 3032 Mr. patrick wilson Vol #: 17
EC 3033 Mr. Deonte' Brown Vol #: 17
EC 3034 Miss. dequilla toney Vol #: 17
EC 3035 Mr. Del Bunce Vol #: 17
EC 3036 Mrs. Clare Walowitz Vol #: 17
EC 3037 Mr. LYNN FRITCHMAN Vol #: 17
EC 3038 Ms. Laurie Harberson Vol #: 17
EC 3039 Miss. Teri Rutter Vol #: 17
EC 3040 Ms. Julia Dalton Vol #: 17
EC 3041 Miss. Julia Brod Vol #: 17
EC 3042 Ms. Debra Stuart Vol #: 17
EC 3043 Mr. Al Loeb Vol #: 17
EC 3044 Ms. zola steele Vol #: 17
EC 3045 Mrs. kate ryan Vol #: 17
EC 3046 Mr. Jack Cline Vol #: 17
EC 3047 Ms. g smith Vol #: 17
EC 3048 Mr. Eric Sweet Vol #: 17
EC 3049 Ms. Jennifer Bernstone Vol #: 17
EC 3050 Ms. Nicole Ring Vol #: 17
EC 3051 Mr. ping jinhua Vol #: 17
EC 3052 Mr. Adam Jackson Vol #: 17
EC 3053 Mr. David Nyberg Vol #: 17
EC 3054 Dr. Nicole Parkhill Vol #: 17
EC 3055 Mrs. Virgie Reams Vol #: 17
EC 3056 Mr. Marc Solomon Vol #: 17
EC 3057 Miss. Elizabeth Gilbert Vol #: 17
EC 3058 Ms. Emily Bersin Vol #: 17
EC 3059 Mr. Jim Chapman Vol #: 17
EC 3060 Mrs. Deborah Rivel Vol #: 17
EC 3061 Mrs. Laura Works Vol #: 17
EC 3062 Ms. Kimberly Olson Vol #: 17
EC 3063 Mr. Quinton Quash Vol #: 17
EC 3064 123hghfff Vol #: 17
EC 3065 Mr. Joseph Burns, Jr. Vol #: 17
EC 3066 Ms. Kara Corthron Vol #: 17
EC 3067 Mrs. Quenby Moone Vol #: 17
EC 3068 Dr. Krista David Vol #: 17
EC 3069 Ms. Leslie Petersma Vol #: 17
EC 3070 Ms. Gail England Vol #: 17
EC 3071 Mrs. kleinschmidt christine Vol #: 17
EC 3072 concerned consumer Vol #: 17
EC 3073 Ms. Samantha Evans Vol #: 17
EC 3074 Ms. Karen Hurley Vol #: 17
EC 3075 Miss. Jerica Shoemaker Vol #: 17
EC 3076 Ms. Judy Coker Vol #: 17
EC 3077 Mr. Byron Easley Vol #: 17
EC 3078 Ms. Elizabeth Perreault Vol #: 17
EC 3079 Miss. Na Wang Vol #: 17
EC 3080 Mr. Ryan Hanau Vol #: 17
EC 3081 Mrs. Elizabeth Purnell Vol #: 17
EC 3082 Mrs. nadja paea Vol #: 17
EC 3083 Mr. nathan kay Vol #: 17
EC 3084 Mr. Kyle Holgate Vol #: 17
EC 3085 Miss. Elizabeth Sandberg Vol #: 17
EC 3086 Ms. Anna Hewitt Vol #: 17
EC 3087 Miss. Tracey Harbridge Vol #: 17
EC 3088 Mr. Richard James Barton Vol #: 17
EC 3089 Mr. Kahreem Hogan Vol #: 17
EC 3090 N/A Vol #: 17
EC 3091 Mr. John Russo Vol #: 17
EC 3092 Ms. Katrina Merkel Vol #: 17
EC 3093 Mrs. Valerie Wilson Vol #: 17
EC 3094 Mr. robert benton Vol #: 17
EC 3095 Mr. Nicholas Hatch Vol #: 17
EC 3096 Miss. Sandra Reed Vol #: 17
EC 3097 Miss. Jennifer Nu Vol #: 17
EC 3098 Mr. Shane Wilson Vol #: 17
EC 3099 Mr. nick czap Vol #: 17
EC 3100 Miss. Amy LaGrange Vol #: 17
EC 3101 Mrs. Erin Grover Vol #: 17
EC 3102 Ms. Alyssa Casciano Vol #: 17
EC 3103 Miss. Sarah Bialahoski Vol #: 17
EC 3104 College of St. Rose (N.Y.) Vol #: 17
EC 3105 Ms. Ashley Langton Vol #: 17
EC 3106 Mrs. Delma Rivera Vol #: 17
2004P-0464 Vitamin D & Calcium & Reduced Risk of Osteoporosis
EC 10 Mrs. Michelle Brown Vol #: 9
2005D-0348 Guidance for Industry and Food and Drug Administration: Procedures for Handling Post-Approval Studies Imposed by PMA Order
EC 3 Mrs zivana Vol #: 1
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
EC 1517 Mr. Bernhard Schmidt Vol #: 24
EC 1518 Mrs. Jodi Clay Vol #: 24
EC 1519 Mr. Eric Dyer Vol #: 24
EC 1520 Mrs. Andrea Rainbacher Vol #: 24
EC 1521 Mr. John Crockwell Vol #: 24
EC 1522 Ms. Debbie Sites Vol #: 24
EC 1523 Ms. Jennifer Pearlman Vol #: 24
EC 1524 Mrs. Karen Reill Vol #: 24
EC 1525 Mrs. Georgia Russell Vol #: 24
EC 1526 Mrs. Susan Wedge Vol #: 24
EC 1527 Mr. Douglas Holmes Vol #: 24
EC 1528 consumer Vol #: 24
EC 1529 Ms. Jill Ohline Vol #: 24
EC 1530 Truman Company Vol #: 24
EC 1531 Mrs. Katharine Ziga Vol #: 24
EC 1532 Danthorpe Inc. Vol #: 24
EC 1533 Ms. Catherine McGinley Vol #: 24
EC 1534 Mrs. Marie Hermetz Vol #: 24
EC 1535 Mrs. Vicki White Vol #: 24
EC 1536 Mr. Andrew Lupatkin Vol #: 24
EC 1537 Mrs. Megan Gorg Vol #: 24
EC 1538 NEDLife Vol #: 24
EC 1539 Mr. Mark Lieb Vol #: 24
EC 1540 Ms. Ann-Tyler Sangston Vol #: 24
EC 1541 Mrs. jennifer hughes Vol #: 24
EC 1542 Ms. Cheryl Hartling Vol #: 24
EC 1543 Mr. ARTHUR ******* Vol #: 24
2005N-0373 Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
EC 1 Regeneration Technologies, Inc. Vol #: 1
EC 2 CJD WATCH Vol #: 1
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
EC 15 University of Minnesota Vol #: 4
EC 16 Compressed Gas Association, Inc. Vol #: 4
EC 17 Veterans Health Administration, Veterans Affairs Vol #: 4
EC 18 Veterans Health Administration, Veterans Affairs Vol #: 4
EC 19 BOC Gases Vol #: 4
EC 20 PharMEDium Services, LLC Vol #: 4
2006D-0353 Guidance for Industry and FDA Staff: Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems
EC 1 LifeScan, Inc. Vol #: 1
EC 2 Advanced Medical Technology Association Vol #: 1
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
C 1585 Form Letters Vol #: 75
2006D-0400 Global Harmonization Task Force, Study Groups 1, 2, 4, and 5; New Proposed and Final Documents; Availability
EC 1 sanofi-aventis US LLC Vol #: 1
2006D-0408 Guidance for Industry and Food and Drug Administration Staff; Annual Reports for Approved Premarket Approval Applications
EC 2 Cook Group Inc. Vol #: 1
EC 3 Advanced Medical Technology Association Vol #: 1
EC 4 Cyberonics, Inc. Vol #: 1
2006D-0463 Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability
EC 2 Pfizer Vol #: 1
EC 3 Schering-Plough Vol #: 1
EC 4 GlaxoSmithKline Vol #: 1
EC 5 American Academy of Otolaryngology- Head and Neck Vol #: 1
2006D-0514 Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
EC 1 Ms. Beth Babecki Vol #: 1
EC 2 Eric Drew Foundation Vol #: 1
2006E-0332 Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,061,703
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0333 Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,614,560
LET 3 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0516 Patent Extension Application for SPRYCEL (dasatinib), U.S. Patent No. 6,596,746
LET 3 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006M-0293 P050044 - Vitagel Surgical Hemostat
NAL 1 FDA Vol #: 1
2006M-0294 P050017 - Zilver Vascular Stent
NAL 1 FDA Vol #: 1
2006M-0295 P050014 - Fuji Computed Radiography Mammography Suite (FCRMS)
NAL 1 FDA Vol #: 1
2006M-0321 P050051 - ARCHITECT AUSAB Reagent Kit, ARCHITECT AUSAB Calibrators, and ARCHITECT AUSAB Controls
NAL 1 FDA Vol #: 1
2006M-0322 P050011 - Adept (4% Icodextrin) Adhesion Reduction Solution
NAL 1 FDA Vol #: 1
2006M-0323 P970043/S020 - LADARVision 4000 Excimer Laser System and the LADAR 6000 Excimer Laser System
NAL 1 FDA Vol #: 1
2006M-0324 P970043/S022 - LADARVision 4000 Excimer Laser System and the LADAR 6000 Excimer Laser System
NAL 1 FDA Vol #: 1
2006M-0325 P020050/S004 - WaveLight ALLEGRETTO WAVE Excimer Laser System
NAL 1 FDA Vol #: 1
2006M-0338 P010029 - Nuflexxa (1% Sodium Hyaluronate)
NAL 1 FDA Vol #: 1
2006M-0339 P030019 - ORTHOVISC High Molecular Weight Hyaluronan
NAL 1 FDA Vol #: 1
2006M-0340 P030016 - Visian ICL (Implantable Collamer Lens)
NAL 1 FDA Vol #: 1
2006M-0341 P050006 - GORE HELEX Septal Occluder
NAL 1 FDA Vol #: 1
2006M-0342 P060004 - MEL 80 Excimer Laser System
NAL 1 FDA Vol #: 1
2006M-0343 P050010 - PRODISC-L Total Disc Replacement
NAL 1 FDA Vol #: 1
2006M-0367 P050023 - Tupos LV/ATx CRT-D, Kronos LV-T CRT-D, 505.U Programmer Software for the ICS 3000, A-K00.7.U Programmer Software for the EPR/TMS 1000PLUS and Corox OTW Steroid Lead
NAL 1 FDA Vol #: 1
2006M-0368 H040006 - AbioCor Implantable Replacement Heart
NAL 1 FDA Vol #: 3
2006M-0374 P040036 - Navistar ThermoCool Deflectable Diagnostic/Ablation Catheter
NAL 1 FDA Vol #: 1
2006M-0389 P050042 - ARCHITECT Anti-HCV Assay; ARCHITECT Anti-HCV Calibrator and ARCHITECT Anti-HCV Control
NAL 1 FDA Vol #: 1
2006N-0062 Expanded Access to Investigational Drugs for Treatment Use
EC 13 Mr. William Seldeen Vol #: 1
EC 14 Mr. William Katakis Vol #: 1
2006N-0279 Agency Information Collection Activities: Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products
N 2 FDA Vol #: 1
2006N-0525 Supplements and Other Changes to an Approved Application
EC 1 EDNC Vol #: 1
EC 2 EDNC Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
EC 887 Canine Recreation Coalition Vol #: 8
EC 888 CONSUMER Vol #: 8
EC 889 Mrs. Elizabeth Martin Vol #: 8
EC 890 A concerned mom Vol #: 8
EC 891 Ms. Renee Silbernagel Vol #: 8
EC 892 Ms. Jacqueline Raven Vol #: 8
EC 893 Ms. marilyn evenson Vol #: 8
EC 894 Ms. Wendy Kobylarz Vol #: 8
EC 895 Ms. Monica Ball Vol #: 8
EC 896 Miss. Ashley Harrison Vol #: 8
EC 897 Ms. Torrie McDonald Vol #: 8
EC 898 Ms. Deborah Romero Vol #: 8
EC 899 Mrs. Connie Durkee Vol #: 8
EC 900 Ms. Josie Coogan Vol #: 8
EC 901 Ms. Natasha Boris Vol #: 8
EC 902 Ms. Diane Luck Vol #: 8
EC 903 Miss. Libby McClayton Vol #: 8
EC 904 Mr. shane wolfe Vol #: 8
EC 905 Dr. Tracy Doherty Vol #: 8
EC 906 Miss. Poornima Dasgupta Vol #: 8
EC 907 Ms. Natalie Barr Vol #: 8
EC 908 Ms. lindsey niedner Vol #: 8
EC 909 Ms. Gwen Carlson Vol #: 8
EC 910 Miss. Molly McCormick Vol #: 8
EC 911 Ms. Lauren Catlin Vol #: 8
EC 912 Mr. Peter Hlavacka Vol #: 8
EC 913 Dr. Melanie Hlavacka Vol #: 8
EC 914 Mr. Garrick Stenger Vol #: 8
EC 915 Ms. lia stalder Vol #: 8
EC 916 Mr. William McMullin Vol #: 8
EC 917 Mrs. Maida Genser Vol #: 8
EC 918 COK Vol #: 8
EC 919 Miss. Deanna Calderaio Vol #: 8
EC 920 Mrs. Joyce Janicki Vol #: 8
EC 921 Mina Abstract Corp. Vol #: 8
EC 922 Mrs. Patricia White Vol #: 8
EC 923 Ms. Alice Bartholomew Vol #: 8
EC 924 Mr. Efren Salazar Vol #: 8
EC 925 Miss. Nancy Stier Vol #: 8
EC 926 Ms. Ksenia Konkina Vol #: 8
EC 927 Mr. Miles Lessen Vol #: 8
EC 928 Ms. Winona Masquat Vol #: 8
EC 929 Ms. Kavita Patel Vol #: 8
EC 930 Mr. mallaroni stephane Vol #: 8
EC 931 Mr. mallaroni stephane Vol #: 8
EC 932 Ms. Sue Nightingale Vol #: 8
EC 933 Mrs. Sheri Greenspan Vol #: 8
EC 934 Ms. tessa hale Vol #: 8
EC 935 Ms. Linda Fair Vol #: 8
EC 936 Mrs. Melissa Capler Vol #: 8
EC 937 Mrs. Gina Hafner Vol #: 8
EC 938 In Defense of Animals Vol #: 8
EC 939 Ms. Jennifer Horan Vol #: 8
EC 940 Mrs. Barbara Birdsey Vol #: 8
EC 941 Mrs. F Savarick Vol #: 8
EC 942 Mrs. Rosemarie Allen Vol #: 8
EC 943 Ms. Kimberley Thomas Vol #: 8
EC 944 Ms. Misty Hay Vol #: 8
EC 945 Miss. Whitney Helms Vol #: 8
EC 946 Ms. Vanessa Beyers Vol #: 8
EC 947 Ms. Lynn Manheim Vol #: 8
EC 948 Mr. David Reuben Vol #: 8
EC 949 Ms. Jeanie Hale Vol #: 8
EC 950 Mrs. Lee Ann Reinfeldt Vol #: 8
EC 951 Mr. Nuno Marques Vol #: 8
EC 952 Ms. Miriam Leiseroff Vol #: 8
EC 953 Mr. Steven Tempelman Vol #: 8
EC 954 Ms. Bea Villa Vol #: 8
EC 955 Mr. Bruce Robertson Vol #: 8
EC 956 Mr. Matt Moulton Vol #: 8
EC 957 Mrs. Tammy Atkinson Vol #: 8
EC 958 Ms. Marsha Alexander Vol #: 8
EC 959 Mr. Joe Salazar Vol #: 8
EC 960 Mr. jacob daniel Vol #: 8
EC 961 Ms. diane leclaire Vol #: 8
EC 962 Mr. Marc Arongino Vol #: 8
EC 963 Miss. Brooke Cartolano Vol #: 8
EC 964 Mrs. Sherry Frey-Brown Vol #: 8
EC 965 Ms. Christina Babst Vol #: 8
EC 966 Ms. Suzanne Spencer Vol #: 8
EC 967 Ms. Donna Hodsdon-Trips Vol #: 8
EC 968 Miss. Lizette Rodriguez Vol #: 8
EC 969 Ms. anita baekey Vol #: 8
EC 970 Dr. Suzanne Gottschang Vol #: 8
EC 971 Mrs. Catherine Redman Vol #: 8
EC 972 Mrs. lillian cohen Vol #: 8
EC 973 Mr. KEVIN NILLES Vol #: 8
EC 974 Mr. Brenden Kjar Vol #: 8
EC 975 Mr. Ryan O'Connell Vol #: 8
EC 976 0 Vol #: 8
EC 977 Mr. aryan shah Vol #: 8
EC 978 Ms. liss lee Vol #: 8
EC 979 Ms. Courtney Donahue Vol #: 8
EC 980 Ms. Sharon Buazard Vol #: 8
EC 981 Ms. Monica Yen Vol #: 8
2006P-0415 Petition Seeking Regulation of Cloned Animals
EC 886 Mr. rick tomko Vol #: 4
EC 887 Mr. CURTIS SCHARTZ Vol #: 4
EC 888 Mr. Joseph Skortoski Vol #: 4
EC 889 Mrs. Cindy Roche Vol #: 4
EC 890 Mr. David Berwanger Vol #: 4
EC 891 Ms. B.L. Haselman Vol #: 4
EC 892 Ms. Colleen Comeau Vol #: 4
EC 893 Mr. Mark Settles Vol #: 4
EC 894 Ms. Claire Cummings Vol #: 4
EC 895 Mrs. Debbie Southard Vol #: 4
EC 896 Mrs. Margaret Hadarich Vol #: 4
EC 897 Mrs. Kirsten Franklin-Temple Vol #: 4
2006P-0535 Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
EC 31 Mrs. Cindy Roche Vol #: 3
2007D-0017 Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnost
GDL 1 Guide Lines Vol #: 1
NAD 1 FDA Vol #: 1
2007E-0010 Patent Extension Application for Chantix (varenicline), U.S. Patent No. 6,410,550
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2007E-0011 Patent Extension Application for Lantus (insulin glargine rDNA origin), U.S. Patent No. 5,101,013
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2007N-0014 Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), and GRAS Affirmation; Electronic Submission
EC 1 celiac spru Vol #: 1
2007N-0015 Agency Information Collection Activities; Proposed Collection; Comment Request; Adoption of the FDA Food Code by Local, State, and Tribal Governments
N 1 FDA Vol #: 1
2007N-0018 Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Form FDA 3356; El
N 1 FDA Vol #: 1

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