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| Dockets Entered
On November 3, 2006
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| Docket #
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| Title
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004P-0349
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| Action on Products containing added Mercury
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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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| 2006D-0268
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| Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| 2006D-0383
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| 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
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| 2006N-0247
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet
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| 2006N-0292
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| Unique Device Identification
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| 2006N-0326
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006N-0425
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification
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| 2006N-0427
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| Agency Information Collection Activities; Proposed Collection; Comment Request;
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| 2006P-0195
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| Determine that Wyeth Pharmaceuticals, Inc. discontinued its original formulation of Zosyn (piperacillin and tazobactam) for reasons unrelated to safety and efficacy and to allow companies to file Abbr
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| 2006P-0201
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| Cefotan (cefotetan injection), equivalent 1 g base/vial and 2 g base/vial, mfged by AstraZeneca has been voluntarily withdrawn from sale for safety and efficacy reasons
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| 2006P-0306
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| Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0442
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| 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
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| C 148
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| Medical Supplies of AMerica, LLC
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| Vol #:
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| 6
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| C 142
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| Medical Supplies of AMerica, LLC
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| Vol #:
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| 10
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| EMC 1335
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| A. Moore
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| Vol #:
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| 6
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| N 7
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| FDA
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| Vol #:
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| 1
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| C 174
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| Nutraceutical Corporation
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| Vol #:
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| 39
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| 2004P-0349
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| Action on Products containing added Mercury
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| EMC 10
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| Dr. J. Koppe
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| Vol #:
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| 4
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| EMC 11
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| Mission Possible International
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| Vol #:
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| 4
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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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| C 18178
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| P. Graebel
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| Vol #:
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| 196
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| C 18179
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| P. Johnston
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| Vol #:
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| 196
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| C 18180
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| J. Klender
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| Vol #:
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| 196
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| C 18181
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| C. Cooper
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| Vol #:
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| 196
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| C 18182
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| A. Medina
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| Vol #:
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| 196
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| C 18183
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| N. Martin
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| Vol #:
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| 196
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| C 18184
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| Gulf Medical
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| Vol #:
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| 198
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| C 18185
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| J. Biles
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| Vol #:
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| 198
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| C 18186
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| C. Ranz
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| Vol #:
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| 198
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| C 18187
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| C. Stringer
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| Vol #:
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| 198
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| C 18188
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| A. James
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| Vol #:
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| 198
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| C 18189
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| W. Gonzalez
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| Vol #:
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| 198
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| C 18190
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| J.
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| Vol #:
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| 198
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| C 18191
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| J. Joseph
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| Vol #:
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| 198
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| C 18192
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| H. Odom
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| Vol #:
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| 198
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| C 18193
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| J. Bashow
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| Vol #:
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| 198
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| C 18194
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| K. Duncan
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| Vol #:
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| 198
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| C 18195
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| R. Dillon
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| Vol #:
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| 198
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| C 18196
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| P. Hutchinson
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| Vol #:
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| 198
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| C 18197
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| D. Eals
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| Vol #:
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| 198
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| C 18198
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| D. Vogt
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| Vol #:
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| 198
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| C 18199
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| C. Sowell
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| Vol #:
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| 198
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| 2006D-0268
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| Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations
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| C 3
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| AIDS Vaccine Advocacy Coalition (AVAC)
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| Vol #:
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| 1
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| EC 5
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| genetics and public policy center
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| Vol #:
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| 1
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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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| EC 5
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| Clinical Pharmacology, Quintiles Inc.
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| Vol #:
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| 1
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