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| Dockets Entered
On November 1, 2004
Tabe of Contents
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| Docket #
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| Title
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| 1994P-0444
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| Proposed Remedial Regs Regarding Monosodium Glutamate (MSG)
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2003D-0112
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| Independent Consultants for Biotechnology Clinical Trias
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0169
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| Dental Amalgam; Request for Information
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| 2003N-0455
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| Training Program for Regulatory Project Managers; Information Available to Industry
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| 2003P-0090
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| Removing Serzone (nefazodone) from the market Bristol-Myers
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| 2003P-0366
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| Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
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| 2004D-0453
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| Compliance Policy Guide Sec. 560.400 - "Imported Milk and Cream Federal Import Milk Act (CPG 7119.05)"
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| 2004D-0459
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| Guidance for Industry on Pharmacokinetics in Pregnancy Study Design, Data Analysis, and Impact on Dosing and Labeling
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| 2004N-0217
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| Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids)
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| 2004N-0408
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| Regulatory Site Visit Training Program
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| 2004P-0164
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| Exemption from the medical devices tracking requirements for Heartstream automated external defibrillators
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| 2004P-0169
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| Erroneous Interpretation of the Statutory Definition of the Term "Dietary Supplement"
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| 2004P-0320
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| Refrain from approving certain applications submitted under section 505(b)(2) of the FDCA that reference Depakote (divalproex sodium delayed- release tablets)
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| 2004Q-0144
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| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
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| 1994P-0444
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| Proposed Remedial Regs Regarding Monosodium Glutamate (MSG)
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| C 55
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| F. Pvinelli
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| Vol #:
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| 6
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| C
281
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| Sanderson Farms, Inc.
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| Vol #:
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| 99
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C
2041
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| Emerson College
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| Vol #:
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| 295
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| EMC 10952
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| L. Green
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| Vol #:
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| 296
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| EMC 10953
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| T. Thompson
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| Vol #:
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| 296
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| EMC 10954
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| J. Fritz
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| Vol #:
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| 296
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| EMC 10955
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| C. Schau
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| Vol #:
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| 296
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| EMC 10956
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| L. Ayad
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| Vol #:
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| 296
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| EMC 10957
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| J. Maul
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| Vol #:
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| 296
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| EMC 10958
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| M. Vaughn
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| Vol #:
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| 296
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| EMC 10959
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| C. Jack
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| Vol #:
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| 296
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| EMC 10960
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| L. Rogers
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| Vol #:
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| 296
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| EMC 10961
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| A. Rode
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| Vol #:
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| 296
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| EMC 10962
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| K. Stump
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| Vol #:
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| 296
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| EMC 10963
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| J. Kaiser
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| Vol #:
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| 296
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| EMC 10964
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| L. Heller
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| Vol #:
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| 296
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| EMC 10965
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| C. McLaughlin
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| Vol #:
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| 296
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| EMC 10966
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| P. March
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| Vol #:
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| 296
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| EMC 10967
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| R. Murray
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| Vol #:
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| 296
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| EMC 10968
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| K. Dickert
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| Vol #:
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| 296
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| EMC 10969
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| K. Stack
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| Vol #:
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| 296
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| EMC 10970
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| L. Cruz
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| Vol #:
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| 296
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| EMC 10971
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| J. Bullock
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| Vol #:
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| 296
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| EMC 10972
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| B. McClintock
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| Vol #:
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| 296
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| EMC 10973
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| C. Brown
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| Vol #:
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| 296
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| EMC 10974
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| K. Miller
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| Vol #:
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| 296
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| EMC 10975
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| K. Thompson
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| Vol #:
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| 296
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| EMC 10976
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| K. Lynch
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| Vol #:
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| 296
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| EMC 10977
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| C. Wehrman
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| Vol #:
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| 296
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 194
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| G. Curry
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| Vol #:
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| 3
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| 2003D-0112
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| Independent Consultants for Biotechnology Clinical Trias
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| C
4
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 1
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 446
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| A. Little
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| Vol #:
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| 9
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| 2003N-0169
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| Dental Amalgam; Request for Information
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| EMC 249
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 250
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 251
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 252
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 253
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 254
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 255
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 256
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 257
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 258
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 259
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 260
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 261
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 262
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 263
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 264
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 265
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 266
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 267
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 268
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 269
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 270
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 271
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 272
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 273
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 274
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 275
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| 2003N-0455
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| Training Program for Regulatory Project Managers; Information Available to Industry
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| LET
1
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| Abbott Laboratories (Abbott)
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| Vol #:
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| 1
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| 2003P-0090
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| Removing Serzone (nefazodone) from the market Bristol-Myers
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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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| 2003P-0366
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| Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
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| C
4
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| Mylan Laboratories, Inc.
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| Vol #:
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| 1
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| 2004D-0453
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| Compliance Policy Guide Sec. 560.400 - "Imported Milk and Cream Federal Import Milk Act (CPG 7119.05)"
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| EMC 1
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| B. Sachau
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| Vol #:
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| 1
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| 2004D-0459
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| Guidance for Industry on Pharmacokinetics in Pregnancy Study Design, Data Analysis, and Impact on Dosing and Labeling
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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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| 2004N-0217
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| Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids)
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| EMC 1
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| F. Bronstein
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| Vol #:
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| 3
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| 2004N-0408
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| Regulatory Site Visit Training Program
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| LET
2
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| Arizona Heart Institute (AHI)
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| Vol #:
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| 1
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| 2004P-0164
|
| Exemption from the medical devices tracking requirements for Heartstream automated external defibrillators
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