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| Dockets Entered
On April 27, 2006
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| Docket #
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| Title
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2001V-0071
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| Laser Light Show
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| 2004N-0408
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| Regulatory Site Visit Training Program
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| 2004P-0149
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| ANDA Suitability for 2.5 mg oxycodone hydrochloride/325 mg acetaminophen and 5 mg oxycodone hydrochloride/325 mg acetaminophen
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| 2005P-0173
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| Request uniform professional labeling for Promethazine Hydrochloride Syrup, USP
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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-0442
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| For patient safety and public health considerations,recommending scheduling tramadol under the Controlled Substances Act
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| 2006D-0020
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| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device
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| 2006D-0066
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| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| 2006D-0150
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| Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and Food and Drug Administration: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Sp
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| 2006N-0019
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| Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
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| 2006N-0133
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer (DTC) Print Adver
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| 2006P-0098
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| Seeks a determination that Loperamide hydrochloride 2 mg orally dissolving film strip is suitable for an ANDA based on the reference listed drug loperamide hydrochloride 2 mg oral chewable tablet (Imo
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| 2006V-0175
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| Laser Light Show
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| C 18265
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| K. Fiola
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| Vol #:
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| 516
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| C 12859
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| K. Fiola
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| Vol #:
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| 806
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1381
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| K. Fiola
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| Vol #:
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| 259
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| C 1382
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| J. Murray
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| Vol #:
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| 259
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| 2001V-0071
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| Laser Light Show
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| VRA 2
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| HFZ-200 to Rauch Planetarium
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| Vol #:
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| 1
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| C 57
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| K. Fiola
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| Vol #:
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| 5
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| 2004N-0408
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| Regulatory Site Visit Training Program
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| NCR 1
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| FDA
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| 1
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| C 7540
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| N. Schaef
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| Vol #:
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| 115
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| C 7541
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| R. Bazan
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| Vol #:
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| 115
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| C 7542
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| P. Dexter
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| Vol #:
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| 115
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| C 7543
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| C. Massena
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| Vol #:
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| 115
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| C 7544
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| L. Natschke
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| Vol #:
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| 115
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| C 7545
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| C. Huddleston
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| Vol #:
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| 115
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| C 7546
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| S. drumm
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| Vol #:
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| 115
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| C 7547
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| F. Selman
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| Vol #:
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| 115
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| C 7548
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| C. Kelly
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| Vol #:
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| 115
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| C 7549
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| B. Burke
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| Vol #:
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| 115
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| 2005P-0442
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| For patient safety and public health considerations,recommending scheduling tramadol under the Controlled Substances Act
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| LET 1
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| FDA/CDER to Pine Grove Recovery Center
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| Vol #:
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| 1
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| 2006D-0020
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| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device
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| C 1
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| North AMerican Spine Society (NASS)
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| Vol #:
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| 2
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| 2006D-0066
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| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| C 20
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| Wheat Foods Council (WFC)
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| Vol #:
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| 1
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| 2006D-0150
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| Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and Food and Drug Administration: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Sp
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| GDL 1
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| Guidance
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| Vol #:
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| 1
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| NAD 1
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| FDA
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| Vol #:
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| 1
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| 2006N-0019
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| Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
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| C 5
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| North American Spine Society (NASS)
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| Vol #:
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| 2
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| 2006N-0133
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to- Consumer (DTC) Print Adver
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2006P-0098
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| Seeks a determination that Loperamide hydrochloride 2 mg orally dissolving film strip is suitable for an ANDA based on the reference listed drug loperamide hydrochloride 2 mg oral chewable tablet (Imo
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| AMD 1
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| MonoSol Rx, LLC
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| Vol #:
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| 1
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| 2006V-0175
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| Laser Light Show
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| ACK 1
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| HFA-305 to Haygood Entertainment
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| Vol #:
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| 1
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| VAR 1
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| Haygood Entertainment
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| Vol #:
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| 1
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