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| Dockets Entered On
November 9, 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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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| 2004P-0334
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| Submit Validation Data for Reprocessed Single-Use Electrosurgical Cutting and Coagulation Devices and Accessories
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| 2005D-0344
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| Class II Special Controls Guidance Document: Tinnitus Masker Devices
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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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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| 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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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16803
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| Life Plus International
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| Vol #:
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| 151
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| LET
16804
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| RKS Inc.
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| Vol #:
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| 151
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| LET
16805
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| Garden of Life, Inc.
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| Vol #:
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| 151
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| LET
16806
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| Anabolic Laboratories,Inc.
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| Vol #:
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| 151
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| LET
16807
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 151
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| LET
16808
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 151
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| LET
16809
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 151
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| LET
16810
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 151
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| LET
16811
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 151
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| LET
16812
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 151
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| LET
16813
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| Natreon, Inc.
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| Vol #:
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| 151
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| LET
16814
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| McLind Corporation
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| Vol #:
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| 151
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| LET
16815
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| Fitness labs Nutrition Corporation
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| Vol #:
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| 151
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| LET
16816
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| Fitness Labs Nutrition Corporation
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| Vol #:
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| 151
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| LET
16817
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| Fitness Labs Nutrition Corporation
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| Vol #:
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| 151
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| LET
16818
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| Fitness Labs Nutrition Corporation
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| Vol #:
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| 151
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| LET
16819
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| Fitness Labs Nutrition Corporation
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| Vol #:
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| 151
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| LET
16820
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| Fitness Nutrition Corporation
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| Vol #:
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| 151
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| LET
16821
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| Perrigo Company of South Carolina
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| Vol #:
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| 151
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| LET
16822
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| Perrigo Company of South Carolina
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| Vol #:
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| 151
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| LET 16823
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| Perrigo Company of South Carolina
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| Vol #:
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| 152
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| LET 16824
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| W.F. Young, Inc.
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| Vol #:
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| 152
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| LET 16825
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| W.F. Young, Inc.
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| Vol #:
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| 152
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| LET 16826
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| AdvoCare International, L.P.
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| Vol #:
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| 152
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| LET
843
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| HFS-800 to HerbsForever, Inc
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| Vol #:
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| 25
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| LET
844
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| HFS-800 to CanPrev LLC
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| Vol #:
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| 25
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| LET
845
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| HFS-800 to New Chapter Inc
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| Vol #:
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| 25
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| LET
846
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| HFS-800 to Creative Enterprises Inc
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| Vol #:
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| 25
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| LET
847
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| HFS-800 to Apex Fitness Group
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| Vol #:
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| 25
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| LET
848
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| HFS-800 to USA CTT Co. Inc
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| Vol #:
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| 25
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| LET
849
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| HFS-800 to Prometheon Labs LLC
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| Vol #:
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| 25
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| LET
850
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| HFS-800 to RKS Inc
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| Vol #:
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| 25
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| C
151
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| Nitta Casings, Inc. (NCI)
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| Vol #:
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| 13
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| C
152
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| Cosmetic, Toiletry, and Fragrance Association (CTFA)
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| Vol #:
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| 13
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| C
19
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| GlaxoSmithKline (GSK)
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| Vol #:
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| 5
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| 2004P-0334
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| Submit Validation Data for Reprocessed Single-Use Electrosurgical Cutting and Coagulation Devices and Accessories
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| ANS
1
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| HFZ-001 to Hyman, Phelps & McNamara, PC
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| Vol #:
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| 1
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| 2005D-0344
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| Class II Special Controls Guidance Document: Tinnitus Masker Devices
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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-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| C 478
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| D. Federici
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| Vol #:
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| 165
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| C
479
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| Planned Parenthood of the Inland Northwest
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| Vol #:
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| 165
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| C 480
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| S. Middleton
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| Vol #:
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| 165
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| C 481
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| Sister P. Miriam, MSBT
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| Vol #:
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| 165
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| C 482
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| L. Rodgers
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| Vol #:
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| 165
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| C 483
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| E. Gallagher
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| Vol #:
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| 165
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| C 484
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| P. McGrath
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| Vol #:
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| 165
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| APE 10
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| Feinberg School of Medicine, Northwestern University
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| Vol #:
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| 1
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| APE 11
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| A Liversidge
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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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| C
43
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| Montgomery Anesthesia Associates, P.C.
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| Vol #:
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| 13
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| C
44
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| Montgomery Anesthesia Associates, P.C.
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| Vol #:
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| 13
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| C
45
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| Montgomery Anesthesia Associates, P.C.
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| Vol #:
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| 13
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| C 46
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| R. Mulner, M.D.
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| Vol #:
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| 13
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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
3
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| National Association of Nurse Practitioners in Women's Health (NPWH)
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| Vol #:
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| 1
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| C
4
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| American Medical Women's Association (AMWA)
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| Vol #:
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| 1
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