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Dockets Management

Dockets Entered On October 30, 2006
Docket # Title
2003D-0478 Guidance on Marketed Unapproved Drugs Compliance Policy Guide
2004D-0198 Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
2004P-0349 Action on Products containing added Mercury
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006D-0331 Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
2006D-0344 Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
2006D-0413 Guidance for Industry: Blue Bird Medicated Feed Labels
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
2006N-0420 Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
2006P-0390 Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0417 Permit the Filing of an ANDA Suitability for Doxycycline Monohydrate Tablets
2006P-0442 Determine that Wyeth Pharmaceuticals, Inc. discontinued its previously-approved formulation of the Reference Listed Drug Zosyn (piperacillin and tazobactam for injection), 40.5 gram pharmacy bulk via
2003D-0478 Guidance on Marketed Unapproved Drugs Compliance Policy Guide
EC 35 Mr. david lowe Vol #: 5
2004D-0198 Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
NAD 2 FDA Vol #: 1
2004P-0349 Action on Products containing added Mercury
EC 23 Mr. Dave Lowe Vol #: 4
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 18171 C. Cooper Vol #: 196
C 18172 P. Burke Vol #: 196
C 18173 I. Calhoun Vol #: 196
C 18174 P. McNulty Vol #: 196
C 18175 C. Pearce Vol #: 196
C 18176 J. Schwand Vol #: 196
C 18177 J. Halonen Vol #: 196
2006D-0331 Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
EC 46 Mr. Leonard Glantz Vol #: 2
EC 47 Association of American Medical Colleges Vol #: 2
2006D-0344 Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
EC 3 Ordway Research Institute Drug Development Center Vol #: 1
2006D-0413 Guidance for Industry: Blue Bird Medicated Feed Labels
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
EC 90 Ms. Domini Bradford Vol #: 3
EC 91 Living Resource Clinic Vol #: 3
EC 92 Dr. Brandon Greenwood Vol #: 3
EC 93 Miss. Lisa Augustine Vol #: 3
EC 94 Dental Care Vol #: 3
EC 95 Dental Care Vol #: 3
EC 96 Dental Care Vol #: 3
EC 97 Dental Care Vol #: 3
EC 98 Dental Care Vol #: 3
EC 99 Dental Care Vol #: 3
EC 100 Dental Care Vol #: 3
EC 101 Dental Care Vol #: 3
EC 102 Dental Care Vol #: 3
EC 103 Dental Care Vol #: 3
EC 104 Dental Care Vol #: 3
EC 105 Dental Care Vol #: 3
EC 106 Dr. George Edwards Vol #: 3
EC 107 Dental Care Vol #: 3
EC 108 Miss. Lucy Mills Vol #: 3
EC 109 Dental Care Vol #: 3
EC 110 Dental Care Vol #: 3
EC 111 Dental Care Vol #: 3
EC 112 Dental Care Vol #: 3
EC 113 Dental Care Vol #: 3
EC 114 Dental Care Vol #: 3
EC 115 Dental Care Vol #: 3
EC 116 Dental Care Vol #: 3
EC 117 Dental Care Vol #: 3
EC 118 Dental Care Vol #: 3
EC 119 Dental Care Vol #: 3
EC 120 IAOMT Vol #: 3
EC 121 Dr. Elaine Brown Vol #: 3
EC 122 Dental Care Vol #: 3
EC 123 Dental Care Vol #: 3
EC 124 Dental Care Vol #: 3
EC 125 Dental Care Vol #: 3
EC 126 Dental Care Vol #: 3
2006N-0420 Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
N 1 FDA Vol #: 1
2006P-0390 Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
EC 11 Mr. Peter Finnegan Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
EC 365 Ms. debbie trujillo Vol #: 2
EC 366 Ms. mars green Vol #: 2
EC 367 Mrs. carol battocchio Vol #: 2
EC 368 Mrs. kim beck Vol #: 2
EC 369 Ms. Lauren Panos Vol #: 2
EC 370 Ms. Marilyn Wilson Vol #: 2
EC 371 Ms. Julie Hoffheins Vol #: 2
EC 372 Mr. Jonathan Krieger Vol #: 2
2006P-0417 Permit the Filing of an ANDA Suitability for Doxycycline Monohydrate Tablets
EC 1 Mr. david lowe Vol #: 1
2006P-0442 Determine that Wyeth Pharmaceuticals, Inc. discontinued its previously-approved formulation of the Reference Listed Drug Zosyn (piperacillin and tazobactam for injection), 40.5 gram pharmacy bulk via
ACK 1 FDA/DDM to Orchid Healthcare Vol #: 1
CP 1 Orchid Healthcare Vol #: 1

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