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Dockets Management

Dockets Entered On May 3, 2006
Docket # Title
1998P-0724 Prohibition of Cochineal Extract and Carmine Color Additives
2000D-1306 Content & Format of the Adverse Reactions Section of Labeling
2004E-0021 Patent Extension, XOLAIR (omalizumab), U.S. Patent No. 6,267,958
2004E-0445 Patent Extension for HUMIRA (adalimumab), U.S. Patent No. 6,090,382
2004P-0329 Request Public Hearings regarding the sales, distribution and use of hand-held Doppler fetoscopes
2004P-0512 Health Claim Petition for Soluble Fiber from Barley
2005D-0385 Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
2005D-0481 Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do
2005E-0233 Patent Extension for OMACOR (EPA ethyl ester and DHA ethyl ester), U.S. Patent No. 5,502,077
2005E-0258 Patent Term Extension Application for OMACOR, U.S. Patent No. 5, 656,667
2005P-0377 Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
2005P-0384 Deficient Peripheral Metabolism of Thyroxine to Triiodothyronine
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2005V-0499 Laser Pointer/Illuminator products GCP-1A. GCP-2
2006D-0017 Human Subject Protection--Information for Institutional Review Boards, Clinical Investigators, and Sponsors; Rescission, Reissuance, and Development of FDA Guidance Documents
2006N-0019 Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
1998P-0724 Prohibition of Cochineal Extract and Carmine Color Additives
C 13 Mary Kay, Inc. Vol #: 1
EC 15 Mrs. Susan Bell Vol #: 1
EC 16 Miss. Terri Miller Vol #: 1
EC 17 Mr. Bryan Thompson Vol #: 1
EC 18 Ms. Sarah VanderVossen Vol #: 1
EC 19 Mr. Jason McManus Vol #: 1
EC 20 Ms. Janice Gudinkas Vol #: 1
EC 21 n/a Vol #: 1
EC 22 Ms. Lisa Tamborini Vol #: 1
EC 23 Mr. Lewis Bayers Vol #: 1
EC 24 Mrs. Susan Wright Vol #: 1
EC 25 san francisco department of public health Vol #: 1
EC 26 Ms. Tiffaney Hale Vol #: 1
EC 27 Mr. James Soos Vol #: 1
EC 28 Bel/Kaukauna U.S.A Vol #: 1
EC 29 Bel/Kaukauna U.S.A. Vol #: 1
EC 30 Ms. Molly Glennen Vol #: 1
EC 31 Mrs. kathleen artrip Vol #: 1
2000D-1306 Content & Format of the Adverse Reactions Section of Labeling
EC 6 Mrs. Theresa staples Vol #: 1
2004E-0021 Patent Extension, XOLAIR (omalizumab), U.S. Patent No. 6,267,958
EC 1 Mr. Dave Lowe Vol #: 1
2004E-0445 Patent Extension for HUMIRA (adalimumab), U.S. Patent No. 6,090,382
EC 1 Mr. Dave Lowe Vol #: 1
2004P-0329 Request Public Hearings regarding the sales, distribution and use of hand-held Doppler fetoscopes
EC 1 American College of Obstetricians and Gynecologist Vol #: 1
TR 1 Transcript of the March 29, 2006 Workshop Vol #: 2
2004P-0512 Health Claim Petition for Soluble Fiber from Barley
EC 2 Miss. Ann Park Vol #: 10
EC 3 Washington Barley Commission Vol #: 10
2005D-0385 Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
GDL 2 Guidance Vol #: 1
NAD 2 FDA Vol #: 1
2005D-0481 Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do
EMC 4 American Public Health Association Vol #: 1
2005E-0233 Patent Extension for OMACOR (EPA ethyl ester and DHA ethyl ester), U.S. Patent No. 5,502,077
EC 1 Mr. Dave Lowe Vol #: 1
2005E-0258 Patent Term Extension Application for OMACOR, U.S. Patent No. 5, 656,667
EC 1 Mr. Dave Lowe Vol #: 1
2005P-0377 Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
SUP 11 Department of the Planet Earth Vol #: 5
2005P-0384 Deficient Peripheral Metabolism of Thyroxine to Triiodothyronine
LET 1 FDA/CDER to Eric K. Pritchard Vol #: 1
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 7922 A. Anderson Vol #: 119
C 7923 D. Leifh Vol #: 119
C 7924 F. Easton Vol #: 119
C 7925 C. Troop Vol #: 119
C 7926 R. Tugillo Vol #: 119
C 7927 Unreadable Vol #: 119
C 7928 S. Siitarel Vol #: 119
C 7929 K. Mathieser Vol #: 119
C 7930 E. Water Vol #: 119
C 7931 M. H. Quarrels Vol #: 119
C 7932 Guy Kropa Vol #: 119
C 7933 M L. Thomas Vol #: 119
C 7934 M. Cook Vol #: 119
C 7935 E. J. Labadini Vol #: 119
C 7936 A. Crawford Vol #: 119
C 7937 J. M. Tullod Vol #: 119
C 7938 B. K. Godfrey Vol #: 119
C 7939 S. Como Vol #: 119
C 7940 D. Boone Vol #: 119
C 7941 A. Spiteoz Vol #: 119
C 7942 L. Hayes Vol #: 119
C 7943 M. Cram Vol #: 119
C 7944 Patirica Barmetter Vol #: 119
C 7945 M. Barmettler Vol #: 119
C 7946 S. Easter Vol #: 119
C 7947 M. Koroknay Vol #: 119
C 7948 V.D. Smith Vol #: 119
C 7949 J. Ayers Vol #: 119
C 7950 M. McCure Vol #: 119
C 7951 M. K. Ziegler Vol #: 119
C 7952 M. Wellhner, MD Vol #: 119
C 7953 R. W. Beaumont, DO Vol #: 119
C 7954 A. Hookie Vol #: 119
C 7955 Unreadable Vol #: 119
C 7956 Unreadable Vol #: 119
C 7957 C. Bissonnette Vol #: 119
C 7958 E. Gorder Vol #: 119
C 7959 P. McCoy Vol #: 119
C 7960 E. Gorder Vol #: 119
C 7961 G. Glass Vol #: 119
C 7962 G. V. Velzer Vol #: 119
C 7963 G. Kolesar Vol #: 119
C 7964 L. K. Hoas Vol #: 119
C 7965 G. Kolesar Vol #: 119
C 7966 M. J. Elliott Vol #: 119
C 7967 K. Jones, N.D. Vol #: 119
C 7968 R. Wang-Chene Vol #: 119
C 7969 M. Rudderhan Vol #: 119
C 7970 S. Rudderham Vol #: 119
C 7971 K. K. Hoffman Vol #: 119
C 7972 D. S. Mills Vol #: 119
C 7973 D. Lee Vol #: 119
C 7974 G. Siegel Vol #: 119
C 7975 C. Weister Vol #: 119
C 7976 D. Schwarze Vol #: 119
C 7977 M. Geisshusei Vol #: 119
C 7978 B. J. Weaver Vol #: 119
C 7979 K. Stern Salkin Vol #: 119
C 7980 C. Alexand3r Vol #: 119
C 7981 D. V Buren Vol #: 119
C 7982 K. Jones, N.D. Vol #: 119
C 7983 G. O'Connor Vol #: 119
C 7984 D. R. Hill Vol #: 119
C 7985 K. Coon Vol #: 119
C 7986 R. F. Montgomery, MD Vol #: 119
C 7987 R. Spangler Vol #: 119
C 7988 O Vencill Vol #: 119
C 7989 S. Spangler Vol #: 119
C 7990 B. Palma Vol #: 119
C 7991 W. Raddle Vol #: 119
C 7992 S. Summer Vol #: 119
C 7993 K. Severson Vol #: 119
C 7994 E. Dunhan Vol #: 119
C 7995 B. W. Bliss Vol #: 119
C 7996 N. Horton Vol #: 119
C 7997 L. Sandkaut Vol #: 119
C 7998 M. Rogers Vol #: 119
C 7999 K. Sanders Vol #: 119
C 8000 K. Soll Vol #: 119
C 8001 S. Perry Vol #: 119
C 8002 S. Perry Vol #: 119
C 8003 V. Simpson Vol #: 119
C 8004 J. Schickel Vol #: 119
C 8005 D. Kelley Vol #: 119
C 8006 G. Fatahaner Vol #: 119
C 8007 C. Parliament Vol #: 119
C 8008 C. Lewis Vol #: 119
C 8009 A. Haynes Vol #: 119
C 8010 J. O'Berry Vol #: 119
C 8011 C. Hayden Vol #: 119
C 8012 K. Lowy Vol #: 119
C 8013 A. Sacerdote, MD Vol #: 119
C 8014 E. Bowie Vol #: 119
C 8015 R. Brown Vol #: 119
C 8016 J. Haselton Vol #: 119
C 8017 Unreadable Vol #: 119
C 8018 M. J. Dallas Vol #: 119
C 8019 R. Torcasso Vol #: 119
C 8020 N. Mar'n Vol #: 119
C 8021 S. Sloan Vol #: 119
C 8022 C . Burrow Vol #: 119
C 8023 L. Hillgren Vol #: 119
C 8024 J. Antonio Vol #: 119
C 8025 S. Peyton Vol #: 119
C 8026 S. Peyton Vol #: 119
C 8027 C. K. Cock Vol #: 119
C 8028 W. Then Vol #: 119
C 8029 C. Rogers Vol #: 119
C 8030 L. Matarazzo Vol #: 119
C 8031 D. Esposito Vol #: 119
C 8032 L. Bardwin Vol #: 119
C 8033 J. Stokes Vol #: 119
C 8034 K. Pearson Vol #: 119
C 8035 K. Wike Vol #: 119
C 8036 J. Eckhart Vol #: 119
C 8037 M. L. Gear Vol #: 119
C 8038 C. Bray Vol #: 119
C 8039 O. Nichols Vol #: 119
C 8040 S. Duff Vol #: 119
C 8041 M. Madden, MD Vol #: 119
C 8042 N. E. Mason Vol #: 119
C 8043 M. Madden, MD Vol #: 119
C 8044 A. A. McCalley Vol #: 119
C 8045 E. A. Gilman Vol #: 119
C 8046 J. Rovotti Vol #: 119
C 8047 A. Huska Vol #: 119
C 8048 K. Jensen Vol #: 119
C 8049 H. Ho Vol #: 119
C 8050 P. Groshart Vol #: 119
C 8051 L. County Vol #: 119
C 8052 M. K. Sutton, MD Vol #: 119
C 8053 L. Gustafson Vol #: 119
C 8054 C.Bell Vol #: 119
C 8055 A. Holley Vol #: 119
C 8056 P.A. Wool Vol #: 119
C 8057 D. Greer Vol #: 119
C 8058 M. Elfers Vol #: 119
C 8059 A. Lee Vol #: 119
C 8060 M. M. Wright Vol #: 119
C 8061 A. Willaugly Vol #: 119
C 8062 C. Dix Vol #: 119
C 8063 M Ball Vol #: 119
C 8064 K Pernice Vol #: 119
C 8065 D. Christenberry, MD Vol #: 119
C 8066 S. Walton Vol #: 119
C 8067 E. Matthews Vol #: 119
C 8068 E. Matthews Vol #: 119
C 8069 N. Fanslow Vol #: 119
C 8070 E. Betz Vol #: 119
C 8071 B. Wilson Vol #: 119
C 8072 R. Wundram Vol #: 119
C 8073 S. Wiger Vol #: 119
C 8074 A. M. Clark Vol #: 119
C 8075 T. Butler Vol #: 119
C 8076 S. Chiaravanont Vol #: 119
C 8077 S. Hepburn Vol #: 119
C 8078 A. Stires Vol #: 119
C 8079 W. Rohland Vol #: 119
C 8080 E. Rohland Vol #: 119
C 8081 S. Cercone Vol #: 119
C 8082 L. Talley Vol #: 119
C 8083 S. S. Creswell Vol #: 119
C 8084 R. D. Creswell Vol #: 119
C 8085 L. Covert Vol #: 119
C 8086 G. McVicker Vol #: 119
C 8087 P. Robertson Vol #: 119
C 8088 V. Lusk Vol #: 119
C 8089 G. Freiler Vol #: 119
C 8090 John Goulart Vol #: 119
C 8091 A. Hyman Vol #: 119
C 8092 K. M. Lee Vol #: 119
C 8093 G. Carpenter Vol #: 119
C 8094 S. Harvey Vol #: 119
C 8095 P. Williams Vol #: 119
C 8096 K. Long Vol #: 119
C 8097 C. Garrow Vol #: 119
C 8098 S. Long Vol #: 119
C 8099 C. Docker Vol #: 119
C 8100 M. Teague Vol #: 119
C 8101 E. Eichenberger Vol #: 119
C 8102 W. Lanier-Perez Vol #: 119
C 8103 P. Casagranda Vol #: 119
C 8104 M. Longbine Vol #: 119
C 8105 N. Tanner Vol #: 119
C 8106 P. Niemi Vol #: 119
C 8107 P. Cole Vol #: 119
C 8108 K. Canizaro Vol #: 119
C 8109 V. Hostetler Vol #: 119
C 8110 J. W. Lenox Vol #: 119
C 8111 D. Smith Vol #: 119
C 8112 L. Blacklock Sander Vol #: 119
C 8113 M. Devtsch Vol #: 119
C 8114 G. Keel Vol #: 119
C 8115 P. Hawes Vol #: 119
C 8116 D. Bliff Vol #: 119
C 8117 J. Weirich Vol #: 119
C 8118 B. Jacobson Vol #: 119
C 8119 P. Thornberry Vol #: 119
C 8120 B. Leadholm-Damgaard Vol #: 119
C 8121 G. Levens Vol #: 119
C 8122 C. Ringo Vol #: 119
C 8123 L. Lindgren Vol #: 119
C 8124 C. Mayron Vol #: 119
C 8125 Dr. G. White Vol #: 119
C 8126 M. Lamonte Vol #: 119
2005V-0499 Laser Pointer/Illuminator products GCP-1A. GCP-2
AMD 1 Night Vision Systems, Inc. Vol #: 1
2006D-0017 Human Subject Protection--Information for Institutional Review Boards, Clinical Investigators, and Sponsors; Rescission, Reissuance, and Development of FDA Guidance Documents
EC 1 Quintiles, Inc. Vol #: 1
EC 2 BILIM PHARMACEUTICALS Vol #: 1
2006N-0019 Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
EC 1 Dr. James Moran Vol #: 2

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