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| Dockets Entered
On February 22, 2007
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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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| |
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| 1999E-5115
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| Patent Extension, ISOLEX 300, #5,035,994
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| |
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| 1999E-5118
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| Patent Extension: Isolex 300, #4,714,680
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| |
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| |
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| |
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| 2006E-0252
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| Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
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| 2006E-0488
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| Patent Extension Application for Isolex 300 (Human Stem Cells and Monoclonal Antibodies), U.S. Patent No. 4,965,204
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| 2006E-0489
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| Patent Extension Application for Isolex 300 (Human Stem Cells and Monoclonal Antibodies), U.S. Patent No. 5,130,144
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| 2006E-0495
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| Patent Extension Application for Model KDR401 and KRD403 Pacemaker, U.S. Patent No. 4,958,632
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| 2006N-0479
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| Insect Repellent-Sunscreen Drug Products for Over-the-Counter Human Use
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| 2006P-0069
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| Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
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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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| 2007N-0005
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| 2007N-0016
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| Sentinel Network To Promote Medical Product Safety
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| 2007P-0062
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| determination whether a previously listed drug Ephilized loxatin (oxaliplatin for injection) Lipophilized powder for infusion, 50 and 100 mg vials has been voluntarily withdrawn from sale for safety
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| 2007P-0065
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| To increase print size of direct-to-consumer advertisements
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| 2007V-0063
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| Variance for Alternate Means of Handling Interlocks - Sabeus AG-1 Laser System
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 18808
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18809
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18810
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18811
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18812
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18813
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18814
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18815
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18816
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18817
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18818
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
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| LET 18819
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18820
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18821
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18822
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18823
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18824
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18825
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18826
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18827
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18828
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18829
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18830
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18831
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18832
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18833
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18834
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18835
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18836
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18837
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18838
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18839
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18840
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18841
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18842
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18843
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18844
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18845
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18846
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18847
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18848
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18849
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18850
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| PuraPharm Corporation
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| Vol #:
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| 170
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| LET 18851
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| New Chapter, Inc.
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| Vol #:
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| 170
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| LET 18852
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| New Chapter, Inc.
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| Vol #:
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| 170
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| LET 18853
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| New Chapter, Inc.
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| Vol #:
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| 170
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| LET 18854
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| New Chapter, Inc.
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| Vol #:
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| 170
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| LET 18855
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| New Chapter, Inc.
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| Vol #:
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| 170
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| LET 18856
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| American Longevity Healthcare, Inc.
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| Vol #:
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| 170
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| LET 18857
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| CCA Industries, Inc.
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| Vol #:
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| 170
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| LET 18858
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 170
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| LET 18859
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| Alva-Amco Pharmacal Companies, Inc.
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| Vol #:
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| 170
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| LET 18860
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| Nature's Way Products, Inc.
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| Vol #:
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| 170
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| LET 18861
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| Nature's Way Products, Inc.
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| Vol #:
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| 170
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| LET 18862
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| New Chapter, Inc.
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| Vol #:
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| 170
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| LET 18863
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| New Chapter, Inc.
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| Vol #:
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| 170
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| 1999E-5115
|
| Patent Extension, ISOLEX 300, #5,035,994
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| |
|
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| LET 3
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
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| 1999E-5118
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| Patent Extension: Isolex 300, #4,714,680
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| |
|
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| LET 3
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| |
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| C 521
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| S. West
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| Vol #:
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| 9
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| C 522
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| V. St. Onge
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| Vol #:
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| 9
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| C 523
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| J. Lewis
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| Vol #:
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| 9
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| C 524
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| L. Ferrell
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| Vol #:
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| 9
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| C 525
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| L. Matteson
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| Vol #:
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| 9
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| C 526
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| R. Beucler
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| Vol #:
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| 9
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| C 527
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| S. Wolfe
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| Vol #:
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| 9
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| C 528
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| M. Durkee
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| Vol #:
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| 9
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| C 529
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| H. Fricke
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| Vol #:
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| 9
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| C 530
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| J. Gage
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| Vol #:
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| 9
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| C 531
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| C. Watkins
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| Vol #:
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| 9
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| C 532
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| A. Peca
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| Vol #:
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| 9
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| C 533
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| B. Fidler
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| Vol #:
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| 9
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| C 534
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| J. Graff
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| Vol #:
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| 9
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| C 535
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| R. Land
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| Vol #:
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| 9
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| C 536
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| J. Cavufel
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| Vol #:
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| 9
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| C 537
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| E. McKenna
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| Vol #:
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| 9
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| C 538
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| A. Turnbull
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| Vol #:
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| 9
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| C 539
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| T. Curler
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| Vol #:
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| 9
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| C 540
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| L. Hopper
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| Vol #:
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| 9
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| |
|
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| C 541
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| Form Letter Count 400
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| Vol #:
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| 10
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| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| |
|
|
| C 18259
|
| K. Mezarno
|
| Vol #:
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| 198
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| |
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| C 18260
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| K. Pautler
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| Vol #:
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| 198
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| |
|
|
| 2006D-0336
|
| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
|
|
| | | | | | | | |
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| |
|
| C 5
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| College of American Pathologists
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| Vol #:
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| 1
|
| |
|
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| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
| |
|
|
| C 3
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| BlueCross BlueShield Association
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| Vol #:
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| 1
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| |
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| EC 19
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| Association for Molecular Pathology
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| Vol #:
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| 1
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| |
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| EC 20
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| American Clinical Laboratory Association
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| Vol #:
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| 1
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| |
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| EC 21
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| Exagen Diagnostics, Inc.
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| Vol #:
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| 1
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| |
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| EC 22
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| Genzyme Genetics
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| Vol #:
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| 1
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| |
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| EC 23
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| Mr. David Levison
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| Vol #:
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| 1
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| |
|
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| EC 24
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| Mr. Jonathan Cohen
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| Vol #:
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| 1
|
| |
|
|
| 2006E-0252
|
| Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0488
|
| Patent Extension Application for Isolex 300 (Human Stem Cells and Monoclonal Antibodies), U.S. Patent No. 4,965,204
|
| |
|
|
| LET 1
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
|
| |
|
| 2006E-0489
|
| Patent Extension Application for Isolex 300 (Human Stem Cells and Monoclonal Antibodies), U.S. Patent No. 5,130,144
|
| |
|
|
| LET 2
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2006E-0495
|
| Patent Extension Application for Model KDR401 and KRD403 Pacemaker, U.S. Patent No. 4,958,632
|
| |
|
|
| LET 2
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2006N-0479
|
| Insect Repellent-Sunscreen Drug Products for Over-the-Counter Human Use
|
| |
|
|
| BKG 1
|
| Background
|
| Vol #:
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| 2
|
| |
|
|
| NRD 1
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| FDA
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| Vol #:
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| 1
|
| |
|
|
| 2006P-0069
|
| Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
|
| |
|
|
| BKG 1
|
| Background Information for NPR1
|
| Vol #:
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| 3
|
| |
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
| |
|
|
| C 56
|
| K. Norris
|
| Vol #:
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| 6
|
| |
|
|
| 2007N-0005
|
| Prescription Drug User Fee Act (PDUFA): Public Meeting
|
| |
|
|
| EC 2
|
| Consumers Union
|
| Vol #:
|
| 1
|
| |
|
|
| EC 3
|
| ISPE
|
| Vol #:
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| 2
|
| |
|
|
| EC 4
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| Dr. Alan Wasserman
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| Vol #:
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| 2
|
| |
|
|
| SUP 1
|
| Coalition for Healthcare Communication
|
| Vol #:
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| 2
|
| |
|
|
| TS 19
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| Pharmaceutical Research and Manufacturers of American (PhRMA)
|
| Vol #:
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| 2
|
| |
|
|
| TS 20
|
| Parkinson Pipeline Project
|
| Vol #:
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| 2
|
|
| | | | | | | | |
|
| |
|
| 2007N-0016
|
| Sentinel Network To Promote Medical Product Safety
|
| |
|
|
| EAPE 221
|
| Brown, Jeffrey
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 222
|
| Feight, Andrea
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 223
|
| Weaver, Brian
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 224
|
| Herron, Margo
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 225
|
| Dowd, Thomas
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 226
|
| Rubinstein, Wade
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 227
|
| Lehrer, Arthur
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 228
|
| Breggar, Michael
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 229
|
| Kleinfelter, William
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 230
|
| Morris, Mitchell
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 231
|
| Kearns, David
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 232
|
| Wells, Barbara
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 233
|
| Nelson , Martin
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 234
|
| Seib, Aaron
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 235
|
| Secunda, Jeffrey
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 236
|
| Birmingham, Robert
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 237
|
| Keller, James
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 238
|
| Wechsler, Jill
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 239
|
| Ginsberg, David
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 240
|
| Stevinson, Michael
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 241
|
| Farup, Christina
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 242
|
| whitehead, james
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 243
|
| Brady, Sean
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 244
|
| Overhage, Marc
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 245
|
| Eguale, Tewodros
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 246
|
| Schondelmeyer, Stephen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 247
|
| Pakhomov, Serguei
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 248
|
| West, Suzanne
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 249
|
| Sacks, Eric
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 250
|
| Diamond, maria
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 251
|
| Wiley, Robin
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 252
|
| Connaughton, Tom
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 253
|
| Thompson, Penny
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 254
|
| Ruggieri, Alexander
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 255
|
| Powell, Tina
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EAPE 256
|
| Jain, Susheel
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 257
|
| Fu, Darrick
|
| Vol #:
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| 1
|
| |
|
|
| EAPE 258
|
| Mechanic, Robert
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 259
|
| Deemer, Cameron
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 260
|
| Alt, Dan
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 261
|
| Gardner, Jennifer
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0062
|
| determination whether a previously listed drug Ephilized loxatin (oxaliplatin for injection) Lipophilized powder for infusion, 50 and 100 mg vials has been voluntarily withdrawn from sale for safety
|
|
|
|
|
|
|
| |
|
|
| ACK 1
|
| FDA / DDM to Regulus PharmaceuticalConsulting, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Regulus PharmaceuticalConsulting, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0065
|
| To increase print size of direct-to-consumer advertisements
|
| |
|
|
| CP 1
|
| Pharmacists Planning Service, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007V-0063
|
| Variance for Alternate Means of Handling Interlocks - Sabeus AG-1 Laser System
|
| |
|
|
| ACK 1
|
| FDA/DDM to Sabeus, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| VAR 1
|
| Sabeus, Inc.
|
| Vol #:
|
| 1
|
|
|
