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| Dockets Entered
On August 25, 2005
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004N-0194
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| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
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| 2004N-0442
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Recall Regulations
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| 2005D-0174
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| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| 2005D-0261
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| Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
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| 2005D-0264
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification Systems for RT-PCR used in Molecular Diagnos
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| 2005N-0065
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| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
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| 2005N-0263
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| Medical Devices; Immunology and Microbiology Devices; Classification of RNA Preanalytical Systems
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 2005N-0296
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators
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| 2005N-0327
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
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| 2005P-0079
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| Determine whether Vioxx Tablets, manufactured by Merck has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
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| 2005P-0134
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| Concerning Marketing Exclusivity for Vitrase (NDA 21-64)
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16525
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| Earthrise Nutritionals, LLC
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| Vol #:
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| 148
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| LET
16526
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| Planetary Formulas
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| Vol #:
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| 148
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| LET
16527
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| Vitogen, Inc.
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| Vol #:
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| 148
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| LET
16528
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| Vitogen, Inc.
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| Vol #:
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| 148
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| LET
16529
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| Vitogen Inc.
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| Vol #:
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| 148
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| LET
16530
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| Vitogen Inc.
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| Vol #:
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| 148
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| LET
16531
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| Vitogen Inc.
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| Vol #:
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| 148
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| LET
16532
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| Vitogen Inc.
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| Vol #:
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| 148
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| LET
16533
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16534
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16535
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16536
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16537
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16538
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16539
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16540
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16541
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16542
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16543
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16544
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16545
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16546
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16547
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16548
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16549
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16550
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| NBTY Inc.
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| Vol #:
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| 148
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| C 147
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| L. Detwiler, DVM
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| Vol #:
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| 12
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| |
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| 2004N-0194
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| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 2004N-0442
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Recall Regulations
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2005D-0174
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| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
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| EC 8
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| Cardinal Health
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| Vol #:
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| 1
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| NEC
1
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| FDA
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| Vol #:
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| 1
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| 2005D-0261
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| Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
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| C
1
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| Rhode Island Blood Center
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| Vol #:
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| 2
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| 2005D-0264
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification Systems for RT-PCR used in Molecular Diagnos
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| GDL
1
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| Guideline
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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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| 2005N-0065
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| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
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| SUP
1
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| National Fisheries Institute
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| Vol #:
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| 1
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| 2005N-0263
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| Medical Devices; Immunology and Microbiology Devices; Classification of RNA Preanalytical Systems
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| | | | | | | | |
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| EC
177
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| Mrs. Frances Kubick
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| Vol #:
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| 4
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| EC
178
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| Individual
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| Vol #:
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| 4
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| EC
179
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| Miss. Samantha Pell
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| Vol #:
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| 4
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| EC
180
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| Mrs. Shannon Magill
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| Vol #:
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| 4
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| EC
181
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| Mrs. Susan Newton
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| Vol #:
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| 4
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| EC
182
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| Dr. Jeff Lundeen
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| Vol #:
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| 4
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| EC
183
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| Ms. Gay Cragun
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| Vol #:
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| 4
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| EC
184
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| Mrs. Carolyn O'Cain
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| Vol #:
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| 4
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| EC
185
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| Mrs. Kendra Keeney
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| Vol #:
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| 4
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| EC
186
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| Mrs. Carolyn Sue Shannon
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| Vol #:
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| 4
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| EC
187
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| Mrs. Shawn Dowd
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| Vol #:
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| 4
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| EC
188
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| Mr. John Matulich
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| Vol #:
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| 4
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| 2005N-0296
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators
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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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| 2005N-0327
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
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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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| 2005P-0079
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| Determine whether Vioxx Tablets, manufactured by Merck has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
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| LET
1
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| HFD-005 to Teva Pharmaceuticals USA
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| Vol #:
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| 1
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| 2005P-0134
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| Concerning Marketing Exclusivity for Vitrase (NDA 21-64)
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| C
2
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| ISTA Pharmaceuticals, Inc. (ISTA)
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| Vol #:
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| 1
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| EC
3
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| Anesco North Broward
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| Vol #:
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| 2
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| EC 4
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| Dr. Adam LIchtman
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| Vol #:
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| 2
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| EC 5
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| ucla
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| Vol #:
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| 2
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| EC 6
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| Dr. jose melendez
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| Vol #:
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| 2
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| EC 7
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| Dr. Lawrence Blanchard
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| Vol #:
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| 2
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| EC 8
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| ACCS
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| Vol #:
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| 2
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| EC 9
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| tmh
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| Vol #:
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| 2
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| EC 10
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| Dr. Timothy Tom
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| Vol #:
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| 2
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| EC 11
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| Dr. Linda Rice
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| Vol #:
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| 2
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| EC 12
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| Dr. James Tucker
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| Vol #:
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| 2
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| EC 13
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| Dr. Carla Lang-Lewin
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| Vol #:
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| 2
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| EC 14
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| Dr. Jonathan Chrest
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| Vol #:
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| 2
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| EC
15
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| Anesthesia Associates of Belleville, Ltd.
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| Vol #:
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| 2
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