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| Dockets Entered
On April 13, 2007
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| Docket #
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| Title
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| 1998N-0337C
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| Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999E-5113
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| Patent Extension: Clinacox (diclazuril), #4,631,278
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| |
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000E-1252
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| Patent Extension Alamast #5,034,230
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| |
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| 2000E-1253
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| Patent Extension Raplon #5,418,226
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| |
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2002E-0156
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| Galileo Intravascular Radiotherapy System
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2004E-0039
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| Patent Extension for CRESTOR (rosuvastatin), U.S. Patent No. RE37,314
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| 2004E-0308
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| Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
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| 2004E-0398
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| Patent Extension for IRESSA (gefitinib), U.S. Patent No. 5,770,599
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| 2005E-0235
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| Patent Extension Application for VESIcare (solifenacin succinate), U.S. Patent No. 6,017,927
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|
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| 2005E-0248
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| Patent Term Extension Application for Fosrenol, U.S. Patent No. 5,968,976
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| |
|
|
| 2005E-0255
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| Patent Extension Application for LUNESTA (exzoplclone), U.S. Patent No. 6,444,673
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| |
|
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| |
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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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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| |
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| 2006D-0480
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| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
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| 2006E-0022
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| Patent Extension Application for SYMLIN (pramlintide acetate), U.S. Patent No. 5,686,411
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| 2006E-0259
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| Patent Extension Application for X-STOP Interspinous Process Decompression System, U.S. Patent No. 6,235,030
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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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| |
|
|
| 2006E-0532
|
| Patent Extension Application for Anthelios SX Daily Moisturizing Cream With Sunscreen, U.S. Patent No. 4,585,597
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| |
|
|
| 2006N-0038
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in the Production, Processing, and Handling of Food
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| |
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| 2006N-0525
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| Supplements and Other Changes to an Approved Application
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| |
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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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| |
|
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| 2007E-0002
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| Patent Extension Application for ELAPRASE (idursulfase), U.S. Patent No. 5,932,211
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| |
|
|
| 2007E-0009
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| Patent Extension Application for Myozyme (Aglucosidase alfa), U.S. Patent No. 6,118,045
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| |
|
|
| 2007E-0046
|
| Patent Extension Application for ZILMAX (zilpaterol hydrochloride), U.S. Patent No. 4,900,735
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| |
|
|
| 2007E-0143
|
| Patent Extension Application for Zolinka, U.S. Patent No. RE38506
|
| |
|
|
| 2007E-0144
|
| Patent Extension Application for VEREGEN, also known as POLYPHENON E, (kunecatechins) Ointment 15%, U.S. Patent No. 5,968,973
|
| |
|
|
| 2007E-0145
|
| Patent Extension Application for INVEGA (paliperidone), U.S. Patent No. 5,518,952
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| |
|
|
| 2007E-0146
|
| Patent Extension Application for LUCENTIS (ranibizumab), U.S. Patent No. 7,060,269
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| |
|
|
| 2007E-0148
|
| Patent Extension Application for TYZEKA (telbivudine), U.S. Patent No. 6,569,837
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| |
|
|
| 2007N-0015
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Adoption of the FDA Food Code by Local, State, and Tribal Governments
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| | | | | | | | |
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| |
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| 2007N-0114
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| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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| |
|
|
| 2007N-0121
|
| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
|
| |
|
|
| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
|
| |
|
|
| 2007P-0142
|
| Incorporate the full proprietary name Zanaflex Capsules, intead of the truncated form of the name Zanaflex
|
| |
|
|
| 2007P-0147
|
| Use of the Term Natural Consistent with USDA's Food Safety and Inspection Service
|
|
| |
|
| 1998N-0337C
|
| Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
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| |
|
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| EC 2
|
| SMU
|
| Vol #:
|
| 1
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| |
|
|
| EREG 2
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| WATER-JEL
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| Vol #:
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| 1
|
| |
|
|
| EREG 3
|
| American Association for Justice
|
| Vol #:
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| 1
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| EMC 4443
|
| A. Ozols
|
| Vol #:
|
| 320
|
| |
|
|
| 1999E-5113
|
| Patent Extension: Clinacox (diclazuril), #4,631,278
|
| |
|
|
| LET 7
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| EMC 677
|
| G. Burdeyney
|
| Vol #:
|
| 24
|
| |
|
|
| 2000E-1252
|
| Patent Extension Alamast #5,034,230
|
| |
|
|
| LET 5
|
| U.S. Patent and Trademark Office to Perkins Coie LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2000E-1253
|
| Patent Extension Raplon #5,418,226
|
| |
|
|
| LET 2
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
|
| |
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
| |
|
|
| C 1412
|
| J. F. Nemastil
|
| Vol #:
|
| 262
|
| |
|
|
| C 1413
|
| K. Meyer
|
| Vol #:
|
| 262
|
| |
|
|
| 2002E-0156
|
| Galileo Intravascular Radiotherapy System
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC 796
|
| Mission Possible International
|
| Vol #:
|
| 10
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC 1470
|
| B. Hickman
|
| Vol #:
|
| 12
|
| |
|
|
| EMC 1471
|
| A. Sander
|
| Vol #:
|
| 12
|
| |
|
|
| EMC 1472
|
| J. Luke
|
| Vol #:
|
| 12
|
|
| | | | | | | | |
|
| |
|
| EMC 1473
|
| J. Luke
|
| Vol #:
|
| 12
|
| |
|
|
| EMC 1474
|
| The Buntin Group
|
| Vol #:
|
| 12
|
|
| |
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
| |
|
|
| EC 4678
|
| Mrs. Barbara Butler
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4679
|
| Ms. G Brandolino
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4680
|
| Ms. Deborah Baker
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4681
|
| Cargill
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4682
|
| Ms. Shannon Gallo
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4683
|
| Mrs. Amy Troiani
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4684
|
| Ms. Lynda LeMay
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4685
|
| AAVS
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4686
|
| Mr. Steven Tempelman
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4687
|
| Ms. Whitney King
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4688
|
| Mrs. Robyn Bishop
|
| Vol #:
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| 54
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| |
|
|
| EC 4689
|
| Ms. Darlyn Thomas
|
| Vol #:
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| 54
|
| |
|
|
| EC 4690
|
| Mrs. Carol Kern
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4691
|
| Ms. Shirley Cofresi
|
| Vol #:
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| 54
|
| |
|
|
| EC 4692
|
| Mrs. Patricia Reinbold
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4693
|
| Ms. Marsha AlexANder
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4694
|
| Mr. Bobbie D. Flowers
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4695
|
| Ms. Karen Curtiss
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4696
|
| Mrs. Kelly Moore
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4697
|
| Texas PETA
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4698
|
| Mr. mark rutter
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4699
|
| Ms. risa mandell
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4700
|
| Ms. Candace Hawkes
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4701
|
| Ms. Mary Ryan
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4702
|
| Ms. Linda Santowski
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4703
|
| Ms. Mary Calzada
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4704
|
| Mrs. Kelly Vrajitoru
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4705
|
| Ms. Marilyn Mayers
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4706
|
| Ms. Caithlin O'Brien
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4707
|
| Miss. Jessica Pacynski
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4708
|
| Mrs. Heather Smith
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4709
|
| Ms. LaVegne Dunn
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4710
|
| Mr. Frank Crawford
|
| Vol #:
|
| 54
|
|
| | | | | | | |
|
| |
|
| EC 4711
|
| Amvets Post 67
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4712
|
| Ms. Kimber Fisher
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4713
|
| Mr. Don Wolford
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4714
|
| Mr. Collin Abbitt
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4715
|
| Ms. Diana Beasley
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4716
|
| Dr. Richard Hyde
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4717
|
| Ms. dion navarro
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4718
|
| Mrs. Doris Curley
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4719
|
| Ms. Caradox Kinomiya
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4720
|
| Mrs. Anita Brandariz
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4721
|
| Mr. S Mital
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4722
|
| Ms. Lisa Smith
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4723
|
| Ms. Judy Perry
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4724
|
| Ms. Allison Saulnier
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4725
|
| Ms. Kamilah Sanders
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4726
|
| Mrs. Jennetta Billhimer
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4727
|
| Mr. Keith Greenhouse
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4728
|
| Ms. Heather Wacome
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4729
|
| Mr. a freeman
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4730
|
| Mr. Eric Carlson
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4731
|
| Miss. Jenna Podraza
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4732
|
| Mr. John Wloszek
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4733
|
| Miss. Natalie Fletcher
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4734
|
| Mrs. Alison Bradshaw
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4735
|
| Carilion Health System
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4736
|
| Ms. Pilar DeMann
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4737
|
| Concerned Daughter,Sister,Mother
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4738
|
| Mrs. Monica Skye
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4739
|
| Mr. Roey Yohai
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4740
|
| Mr. Tom Sunlake
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4741
|
| Ms. Dawn Matthews
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4742
|
| Mrs. Rosa Herod
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4743
|
| Dr. S. Bernatsky
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4744
|
| Ms. Elaine Daley
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4745
|
| Ms. Lisa Orozco
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4746
|
| Ms. Andrea Jude
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4747
|
| Miss. Mary Wilson
|
| Vol #:
|
| 54
|
|
| | | | | | | | |
|
| |
|
| EC 4748
|
| Mrs. Jennifer Owen
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4749
|
| Mr. Anthony Montapert
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4750
|
| William Paterson University
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4751
|
| Ms. Lisa Ziccarelli
|
| Vol #:
|
| 54
|
| |
|
|
| EMC 279
|
| C. Moon
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 280
|
| I. Waithe
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 281
|
| C. Shranko
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 282
|
| M. Kiriacon
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 283
|
| M. Mahony
|
| Vol #:
|
| 5
|
| |
|
|
| 2004E-0039
|
| Patent Extension for CRESTOR (rosuvastatin), U.S. Patent No. RE37,314
|
| |
|
|
| LET 6
|
| U.S. Patent and Trademark Office to Morgan Lewis & Bockius LLP
|
| Vol #:
|
| 1
|
|
| |
|
| 2004E-0308
|
| Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
|
| |
|
|
| LET 6
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0398
|
| Patent Extension for IRESSA (gefitinib), U.S. Patent No. 5,770,599
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2005E-0235
|
| Patent Extension Application for VESIcare (solifenacin succinate), U.S. Patent No. 6,017,927
|
| |
|
|
| LET 6
|
| U.S. Patent and Trademark Office to Sughrue Mion PLLC
|
| Vol #:
|
| 1
|
| |
|
|
| 2005E-0248
|
| Patent Term Extension Application for Fosrenol, U.S. Patent No. 5,968,976
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2005E-0255
|
| Patent Extension Application for LUNESTA (exzoplclone), U.S. Patent No. 6,444,673
|
| |
|
|
| LET 4
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0272
|
| Irradiation in the Production, Processing, and Handling of Food
|
| |
|
|
| EREG 349
|
| P. Exline
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 350
|
| Union of Concerned Scientisis
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 351
|
| K. Heatherington
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 352
|
| Natural Focus on Health
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 353
|
| Service for Counseling & Family Enrichment
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 354
|
| D. Heaney
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 355
|
| W. Himmelbauer
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 356
|
| W. Nier
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 357
|
| R. Oliver
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 358
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| J. Cobb
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| 4
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| EREG 359
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| Organic Consumers Union
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| Vol #:
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| 4
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| EREG 360
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| A. Jansz
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| Vol #:
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| 4
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| EREG 361
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| H. Ball
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| 4
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| EREG 362
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| H. North
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| 4
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| EREG 363
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| S. Urbanowitz
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| 4
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| EREG 364
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| J. Wangh
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| 4
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| EREG 365
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| D. Brine
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| 4
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| EREG 366
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| OMB-Office of Information & Regulatory Affairs
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| 4
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| EREG 367
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| T. McBride
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| Vol #:
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| 4
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| EREG 368
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| U. S. Health & Environmental Watch
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| 4
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| EREG 369
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| J. Balcom
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| 4
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| EREG 372
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| A. Andersson
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| 4
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| EREG 373
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| E. Aragon
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| 4
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| EREG 374
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| J. Macchia
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| 4
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| EREG 375
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| Auburn University Sustainability Initative
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| 4
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| EREG 376
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| R. Renne
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| 4
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| EREG 377
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| M. Clark
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| 4
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| EREG 378
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| G. Maslanka
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| 4
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| L. Zuckerman
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| 4
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| EREG 380
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| J. Earl
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| 4
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| EREG 381
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| P. Parsley
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| 4
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| EREG 382
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| R. Low
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| 4
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| EREG 383
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| C. Webb
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| 4
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| EREG 384
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| N. Schweiger
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| 4
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| EREG 385
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| V. Colletti
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| 4
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| EREG 386
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| C. C. O. F.
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| 4
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| EREG 387
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| A. Schulman
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| Vol #:
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| 4
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| EREG 388
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| Union of Concerned Scientists
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| Vol #:
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| 4
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| EREG 389
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| S. Shigley
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| Vol #:
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| 4
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| EREG 390
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| Union of Concerned Scietists
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| Vol #:
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| 4
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| EREG 391
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| W. Holley
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| Vol #:
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| 4
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| EREG 392
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| Chewonki Foundation
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| Vol #:
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| 4
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| EREG 393
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| L. Larrabee
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| Vol #:
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| 4
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| EREG 394
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| Union of Concerned Scientists
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| Vol #:
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| 4
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| EREG 395
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| E. Fischer
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| Vol #:
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| 4
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| EREG 396
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| J. Cassidy
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| Vol #:
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| 4
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| EREG 397
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| K. Shoaf
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| 4
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| EREG 398
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| H. Robertson
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| 4
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| EREG 399
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| W. Mejia
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| Vol #:
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| 4
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| EREG 400
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| G. Marano
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| 4
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| EREG 401
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| D. Jessler
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| 4
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| EREG 402
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| G. Baccari
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| 4
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| H. Adkisson
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| 4
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| EREG 404
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| L. Loring
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| 4
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| EREG 405
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| Union of Concerned Scientists
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| Vol #:
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| 4
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| |
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| EREG 406
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| C. Harris
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| Vol #:
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| 4
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| EREG 407
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| C. Davis
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| 4
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| EREG 408
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| P. Purtell
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| Vol #:
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| 4
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| EREG 409
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| Union of Concerned Scientists
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| Vol #:
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| 4
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| |
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| EREG 410
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| E. Gilkyson
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| Vol #:
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| 4
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| EREG 411
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| M. Creighton
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| Vol #:
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| 4
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| EREG 412
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| M. Stack
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| Vol #:
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| 4
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| EREG 413
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| Women's Caucus for Art
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| Vol #:
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| 4
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| EREG 414
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| D. Dobrovolny
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| Vol #:
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| 4
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| EREG 415
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| S. Kyle
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| Vol #:
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| 4
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| EREG 416
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| J. Hayes
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| Vol #:
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| 4
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| EREG 417
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| S. Rowland
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| Vol #:
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| 4
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| EREG 418
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| I. Goldberg
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| Vol #:
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| 4
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| EREG 419
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| S. Parham
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| Vol #:
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| 4
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| EREG 420
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| M. Neidell
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| Vol #:
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| 4
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| EREG 421
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| PerfCon
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| Vol #:
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| 4
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| EREG 422
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| R. Acosta
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| 4
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| EREG 423
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| J. Buzzell
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| Vol #:
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| 4
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| EREG 424
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| Jamieson Chiropractic
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| Vol #:
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| 4
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| EREG 425
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| K. Anderson
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| Vol #:
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| 4
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| EREG 426
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| Meatingplace
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| Vol #:
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| 4
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| EREG 427
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| S. Eastwood
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| Vol #:
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| 4
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| G. Levy
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| 4
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| J. Atterholt
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| 4
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| M. Thomas
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| 4
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| L. Boynton
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| 4
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| M. DuRussel
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| 4
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| EREG 433
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| M. Hernandez
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| 4
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| W. Bolt
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| 4
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| L. Quinet
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| 4
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| |
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| EREG 436
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| C. E. O. Pipe Organs/Golden Ponds Farm
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| Vol #:
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| 4
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| |
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| EREG 437
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| R. Jamieson
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| 4
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| C. Ehly
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| |
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| L. Williams
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| 4
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| |
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| M. Andersen-Zimmer
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| 4
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| K. DeAngelis
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| 4
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| R. Kestler
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| 4
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| E. Hoffman
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| 4
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| J. Hudgins
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| 4
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| |
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| EREG 445
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| J. Vinson
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| Vol #:
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| 4
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| |
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| EREG 446
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| HealthPartners
|
| Vol #:
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| 4
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| |
|
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| EREG 447
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| Graduate Program in Studies of the Future-University of Houston
|
| Vol #:
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| 4
|
| |
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| EREG 448
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| S. S. N. D.
|
| Vol #:
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| 4
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| |
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| EREG 449
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| D. Burack
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| Vol #:
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| 4
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| |
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| EREG 450
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| G. Zahradnik
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| 4
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| |
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| EREG 451
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| P. Edwards
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| 4
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| |
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| EREG 452
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| H. Bourscheidt
|
| Vol #:
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| 4
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| |
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| EREG 453
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| E. Shaw
|
| Vol #:
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| 4
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| |
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| EREG 454
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| Private Practice
|
| Vol #:
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| 4
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| |
|
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| EREG 455
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| C. Brewer
|
| Vol #:
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| 4
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| |
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| EREG 456
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| S. McMenamin
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| 4
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| |
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| EREG 457
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| J. Speer
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| 4
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| |
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| EREG 458
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| T. Matheny
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| 4
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| |
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| EREG 459
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| J. Rosenblood
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| 4
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| |
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| EREG 460
|
| L. Straus-Edwards
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| Vol #:
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| 4
|
| |
|
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| EREG 461
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| Union of Concerned Scientists
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| Vol #:
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| 4
|
| |
|
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| EREG 462
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| J. Dowell
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| Vol #:
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| 4
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| |
|
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| EREG 463
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| K. Drake-Martinez
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| Vol #:
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| 4
|
| |
|
|
| EREG 464
|
| University of California at San Diego
|
| Vol #:
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| 4
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| |
|
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| EREG 465
|
| R. Harris
|
| Vol #:
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| 4
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| |
|
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| EREG 466
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| V. Pimley
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| Vol #:
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| 4
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| |
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| EREG 467
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| H. Spanga
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| 4
|
|
| |
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
|
| | | | | | | | |
|
| |
|
| C 715
|
| A. Fither
|
| Vol #:
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| 32
|
| |
|
|
| C 716
|
| J. Siple
|
| Vol #:
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| 32
|
| |
|
|
| C 717
|
| L. Larson
|
| Vol #:
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| 32
|
| |
|
|
| C 718
|
| J. Kelihanaikukaukahihuliheekahaunaele
|
| Vol #:
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| 32
|
| |
|
|
| C 719
|
| J. Harris
|
| Vol #:
|
| 32
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C 18295
|
| R. Taylor
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| 198
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| |
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| C 18296
|
| P. Lofthus
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| 198
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| |
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|
| 2006D-0480
|
| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
|
| |
|
|
| ANS 1
|
| FDA/OC to S. Elizabeth Clay
|
| Vol #:
|
| 1
|
| |
|
|
| C 2
|
| L. Halcon, PhD
|
| Vol #:
|
| 1
|
| |
|
|
| C 3
|
| S. K. Keller
|
| Vol #:
|
| 1
|
| |
|
|
| C 4
|
| M. M. Breda
|
| Vol #:
|
| 1
|
| |
|
|
| C 5
|
| C. J. Whewell
|
| Vol #:
|
| 1
|
| |
|
|
| EXT 1
|
| S. E. Clay
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0022
|
| Patent Extension Application for SYMLIN (pramlintide acetate), U.S. Patent No. 5,686,411
|
| |
|
|
| LET 6
|
| U.S. Patent and Trademark Office to Amylin Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0259
|
| Patent Extension Application for X-STOP Interspinous Process Decompression System, U.S. Patent No. 6,235,030
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0495
|
| Patent Extension Application for Model KDR401 and KRD403 Pacemaker, U.S. Patent No. 4,958,632
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0532
|
| Patent Extension Application for Anthelios SX Daily Moisturizing Cream With Sunscreen, U.S. Patent No. 4,585,597
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 2
|
|
| |
|
| 2006N-0038
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in the Production, Processing, and Handling of Food
|
| |
|
|
| C 1
|
| T. Lee
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0525
|
| Supplements and Other Changes to an Approved Application
|
| |
|
|
| NEC 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
| |
|
|
| C 81
|
| J. Beckham
|
| Vol #:
|
| 7
|
| |
|
|
| C 82
|
| J. Skirha
|
| Vol #:
|
| 7
|
| |
|
|
| C 83
|
| Y. S. Bernstein
|
| Vol #:
|
| 7
|
|
| | | | | | | | |
|
| |
|
| 2007E-0002
|
| Patent Extension Application for ELAPRASE (idursulfase), U.S. Patent No. 5,932,211
|
| |
|
|
| LET 4
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2007E-0009
|
| Patent Extension Application for Myozyme (Aglucosidase alfa), U.S. Patent No. 6,118,045
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
|
| |
|
| 2007E-0046
|
| Patent Extension Application for ZILMAX (zilpaterol hydrochloride), U.S. Patent No. 4,900,735
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2007E-0143
|
| Patent Extension Application for Zolinka, U.S. Patent No. RE38506
|
| |
|
|
| APP 1
|
| Sloan-Kettering Institute for Cancer Research and The Trustees of Columbia University
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2007E-0144
|
| Patent Extension Application for VEREGEN, also known as POLYPHENON E, (kunecatechins) Ointment 15%, U.S. Patent No. 5,968,973
|
| |
|
|
| APP 1
|
| Mitsui Norin Co., Ltd., and Cancer Institute (Hospital), Chinese Academy of Medical Sciences
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2007E-0145
|
| Patent Extension Application for INVEGA (paliperidone), U.S. Patent No. 5,518,952
|
| |
|
|
| APP 1
|
| Johnson & Johnson
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
|
| |
|
| 2007E-0146
|
| Patent Extension Application for LUCENTIS (ranibizumab), U.S. Patent No. 7,060,269
|
| |
|
|
| APP 1
|
| Genentech, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2007E-0148
|
| Patent Extension Application for TYZEKA (telbivudine), U.S. Patent No. 6,569,837
|
| |
|
|
| APP 1
|
| Idenix Pharmaceuticals, Inc., Centre National de La Recherche Scientifique, and L'Universite Montpel
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0015
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Adoption of the FDA Food Code by Local, State, and Tribal Governments
|
| |
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0114
|
| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
|
| |
|
|
| EAPE 54
|
| Vaughan, William
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 55
|
| O'Connell, Cathleen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 56
|
| McKeever, Paula
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 57
|
| Hastings, Bruce
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0121
|
| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
|
| |
|
|
| EAPE 52
|
| Biddick, Kendra
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 53
|
| Kaufman, Martin
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EAPE 54
|
| Marks, Norman
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0085
|
| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
|
| |
|
|
| C 6
|
| C. Shade
|
| Vol #:
|
| 2
|
| |
|
|
| C 7
|
| S. Zonis
|
| Vol #:
|
| 2
|
| |
|
|
| C 8
|
| Jefferson Medical College
|
| Vol #:
|
| 2
|
| |
|
|
| C 9
|
| B. Kimmerle
|
| Vol #:
|
| 2
|
| |
|
|
| C 10
|
| G. Giuliano
|
| Vol #:
|
| 2
|
| |
|
|
| 2007P-0142
|
| Incorporate the full proprietary name Zanaflex Capsules, intead of the truncated form of the name Zanaflex
|
| |
|
|
| ACK 1
|
| FDA/DDM to Acorda Therapeutics, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Acorda Therapeutics, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0147
|
| Use of the Term Natural Consistent with USDA's Food Safety and Inspection Service
|
| |
|
|
| ACK 1
|
| FDA/DDM to Sara Lee Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Sara Lee Corporation
|
| Vol #:
|
| 1
|
|
|
