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| Dockets Entered
On September 19, 2007
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998D-0307
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| Exports/Imports under FDA export reform/enhancement Act 1996
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| 1999D-1878
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| Good Manufacturing Practice for Blood and Blood Components:
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| 2002D-0081
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| Hepatitis B Surface Antigen (HBSAG) Assays to Test Blood
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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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| 2007D-0223
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| Guidance for Industry on Use of the Computer Crossmatch
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| 2007M-0344
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| P050043 - Femoral Introducer Sheath and Hemostasis (FISH) Device 5, 6, and 8 French
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| 2007N-0264
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| Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule
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| 2007N-0321
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
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| 2007N-0325
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| Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Section 502 of the Federal Food, Drug and Cosmetic Act / Section 351 of the Public Health Service Act; A
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| 2007N-0330
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| Presidential Interagency Working Group on Import Safety; Public Meeting
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| 2007P-0282
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| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
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| 2007P-0297
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| Request to reconsider the failure to approve Provenge
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| 2007P-0333
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| Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa
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| 2007P-0351
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| Address the potential drug-safety-and efficacy-related issues that are expected to arise in connection with the issuance of final approvals for at least seven (7) tentatively-approved applications see
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| 1978N-0038
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| Sunscreen Drug Products
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| EC 2408
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| Mrs. Michaelene Hayward
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| Vol #:
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| 161
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| EC 2409
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| Mrs. Tiffany Zehnal
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| Vol #:
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| 161
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| EC 2410
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| Mrs. Judith Rose
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| Vol #:
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| 161
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| EC 2411
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| Dr. Jo Jenner
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| Vol #:
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| 161
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| EC 2412
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| Mrs. Daphne T Stevens
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| Vol #:
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| 161
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| EC 2413
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| Mrs. Laura Belgiorno
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| Vol #:
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| 161
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| EC 2414
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| Mrs. jan zimmer
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| Vol #:
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| 161
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| EC 2415
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| Mrs. Ellen Williams
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| Vol #:
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| 161
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| EC 2416
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| Ms. Danielle Friend
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| Vol #:
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| 161
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| EC 2417
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| Ms. Kerrie kortis
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| Vol #:
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| 161
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| EC 2418
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| Ms. Laura Reany
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| Vol #:
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| 161
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| EC 2419
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| Ms. Kimberly Odden
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| Vol #:
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| 161
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| EC 2420
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| Mrs. Julia Close
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| Vol #:
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| 161
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| EC 2421
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| Dr. maria delgado
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| Vol #:
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| 161
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| EC 2422
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| Mrs. Michelle Chow
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| Vol #:
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| 161
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| EC 2423
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| Ms. cynthia connell
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| Vol #:
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| 161
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 20836
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| INTEGRITY
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| Vol #:
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| 181
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| LET 20837
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| NATURAL ORGANICS, INC.
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| Vol #:
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| 181
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| LET 20838
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| Arkopharma, LLC
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| Vol #:
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| 181
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| LET 20839
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| Arkopharma, LLC
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| Vol #:
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| 181
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| LET 20840
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| Market America, Inc.
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| Vol #:
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| 181
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| LET 20841
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| Market America, Inc.
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| Vol #:
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| 181
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| LET 20842
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| Bausch & Lomb
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| Vol #:
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| 181
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| LET 20843
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| CreoMed, Inc.
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| Vol #:
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| 181
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| LET 20844
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| CreoMed, Inc.
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| Vol #:
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| 181
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| LET 20845
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| SOLSTICE MEDICINE COMPANY
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| Vol #:
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| 181
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| LET 20846
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| SOLSTICE MEDICINE COMPANY
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| Vol #:
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| 181
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| LET 20847
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| SOLSTICE MEDICINE COMPANY
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| Vol #:
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| 181
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| LET 20848
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| SOURCE NATURALS
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| Vol #:
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| 181
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| LET 20849
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| SOURCE NATURALS
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| Vol #:
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| 181
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| LET 20850
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| PROCAPS LABORATORIES
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| Vol #:
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| 181
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| LET 20851
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| Law Offices of Robert e. Armstrong
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| Vol #:
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| 181
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| LET 20852
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| Law Offices of Robert e. Armstrong
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| Vol #:
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| 181
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| LET 20853
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| PuraPharm
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| Vol #:
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| 181
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| LET 20854
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| PuraPharm
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| Vol #:
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| 181
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| LET 20855
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| PuraPharm
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| Vol #:
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| 181
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| LET 20856
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| NUTRAGENESIS
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| Vol #:
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| 181
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| LET 20857
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| NUTRAMAX
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| Vol #:
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| 181
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| LET 20858
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| HIGHLAND LABORATORIES
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| Vol #:
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| 181
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| LET 20859
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| HIGHLAND LABORATORIES
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| Vol #:
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| 181
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| LET 20860
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| Healthcare Brands International
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| Vol #:
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| 181
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| LET 20861
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| CCA Industries, Inc.
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| Vol #:
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| 181
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| LET 20862
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| CCA Industries, Inc.
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| Vol #:
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| 181
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| LET 20863
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| IOVATE Health Sciences USA, Inc.
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| Vol #:
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| 181
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| LET 20864
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| CCA Industries, Inc.
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| Vol #:
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| 181
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| LET 20865
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| CCA Industries, Inc.
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| Vol #:
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| 181
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| LET 20866
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| CCA Industries, Inc.
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| Vol #:
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| 181
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| LET 20867
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| CCA Industries, Inc.
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| Vol #:
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| 181
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| LET 20868
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| MARTEK
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| Vol #:
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| 181
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| LET 20869
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| WELEDA
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| Vol #:
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| 181
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| LET 20870
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| WELEDA
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| Vol #:
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| 181
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| LET 20871
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| WELEDA
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| Vol #:
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| 181
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| LET 20872
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| NOVARTIS
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| Vol #:
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| 181
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| LET 20873
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| Jamba Juice
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| Vol #:
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| 181
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| LET 20874
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| Emord & Associates, P.C.
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| Vol #:
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| 181
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| LET 20875
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| IOVARE
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| Vol #:
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| 181
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| 1998D-0307
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| Exports/Imports under FDA export reform/enhancement Act 1996
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| EC 57
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| Ms. Victoria Fisher
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| Vol #:
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| 1
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| EC 58
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| Mrs. Teresa Ruby
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| Vol #:
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| 1
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| EC 59
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| Mr. Ranel Cox
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| Vol #:
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| 1
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| EC 60
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| shani ltd
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| Vol #:
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| 1
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| 1999D-1878
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| Good Manufacturing Practice for Blood and Blood Components:
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| EC 1
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| Dr. liu kai
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| Vol #:
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| 1
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| 2002D-0081
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| Hepatitis B Surface Antigen (HBSAG) Assays to Test Blood
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| EC 3
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| PPTA
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| Vol #:
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| 1
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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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| C 145
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| Tami L. Kander
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| Vol #:
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| 7
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| 2007D-0223
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| Guidance for Industry on Use of the Computer Crossmatch
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| EC 6
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| Ms. Sandra Thoman
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| Vol #:
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| 1
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| 2007M-0344
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| P050043 - Femoral Introducer Sheath and Hemostasis (FISH) Device 5, 6, and 8 French
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| AAV 1
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| Morris Innovative Research, Inc.
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| Vol #:
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| 1
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| 2007N-0264
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| Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule
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| EC 1
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| Ms. Alicia Siefring
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| Vol #:
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| 1
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| EC 2
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| U.S. FDA/Richmond Resident Post
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| Vol #:
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| 1
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| 2007N-0321
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
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| EC 3
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| Ms. Allisa Imming
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| Vol #:
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| 1
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| EC 4
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| Mr. Joseph Brenner
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| Vol #:
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| 1
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| EC 5
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| Ms. R Craig
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| Vol #:
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| 1
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| EC 6
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| Ms. Claudine Wallace
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| Vol #:
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| 1
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| EC 7
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| Patient Survivor's Advisory Council
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| Vol #:
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| 1
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| EC 8
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| Ms. Jacqueline Lasahn
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| Vol #:
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| 1
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| EC 9
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| Mr. Thomas Brown
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| Vol #:
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| 1
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| EC 10
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| Ms. Margaret Fleming
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| Vol #:
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| 1
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| EC 11
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| Ms. Kelly McPherson
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| Vol #:
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| 1
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| EC 12
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| Dartmouth College
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| Vol #:
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| 1
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| EC 13
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| University of Minnesota
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| Vol #:
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| 1
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| 2007N-0325
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| Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Section 502 of the Federal Food, Drug and Cosmetic Act / Section 351 of the Public Health Service Act; A
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| EC 1
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| Pall Medical
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| Vol #:
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| 1
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| 2007N-0330
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| Presidential Interagency Working Group on Import Safety; Public Meeting
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| EC 105
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| American Assoc. for Lab. Accreditation
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| Vol #:
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| 1
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| EC 106
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| Design Chain Associates, LLC
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| Vol #:
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| 1
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| EC 107
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| Ms. Janine Hardin
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| Vol #:
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| 1
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| EC 108
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| Mrs. Sabrina Curtis
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| Vol #:
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| 1
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| EC 109
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| Mrs. Sabrina Curtis
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| Vol #:
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| 1
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| EC 110
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| Mrs. Aileen Sakamoto
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| Vol #:
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| 1
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| EC 111
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| individual
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| Vol #:
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| 1
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| EC 112
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| Ms. Nicole Orner
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| Vol #:
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| 1
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| EC 113
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| American Iron and Steel Institute
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| Vol #:
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| 1
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| 2007P-0282
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| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
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| EC 60
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| Ms. Judith Daly
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| Vol #:
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| 1
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| 2007P-0297
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| Request to reconsider the failure to approve Provenge
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| EC 101
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| Mr. Al Barone
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| Vol #:
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| 1
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| 2007P-0333
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| Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa
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| ACK 3
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| FDA/DDM to Dave Wayne
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| Vol #:
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| 1
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| ACK 4
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| FDA/DDM to John Gilbert
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| Vol #:
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| 1
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| ACK 5
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| FDA/DDM to Michael E. Masterman
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| Vol #:
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| 1
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| ACK 6
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| FDA/DDM to John W. Shaw
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| Vol #:
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| 1
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| ACK 7
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| FDA/DDM to Rebecca Gilbert
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| Vol #:
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| 1
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| CP 3
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| Dave Wayne
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| Vol #:
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| 1
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| CP 4
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| John Gilbert
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| Vol #:
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| 1
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| CP 5
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| Michael E. Masterman
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| Vol #:
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| 1
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| CP 6
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| John W. Shaw
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| Vol #:
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| 1
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| CP 7
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| Rebecca Gilbert
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| Vol #:
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| 1
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| 2007P-0351
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| Address the potential drug-safety-and efficacy-related issues that are expected to arise in connection with the issuance of final approvals for at least seven (7) tentatively-approved applications see
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| ACK 1
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| FDA/ DDM to Engal & Novitt, LLP
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| Vol #:
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| 1
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| ACK 2
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| FDA/DDM to Engel & Novitt, LLP
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| Vol #:
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| 1
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| CP 1
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| Engel & Novitt, LLP
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| Vol #:
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| 1
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| PSA 1
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| Engal & Novitt, LLP
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| Vol #:
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| 1
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