| | | | | |
| |
|
|
| Dockets Entered
On June 1, 2007
|
|
|
|
|
|
|
| |
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1977N-0094L
|
| Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
|
| |
|
|
| 1981N-0033P
|
| Antigingivitis & Antiplaque-Related Claims
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
| |
|
|
| 2005D-0112
|
| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
|
| |
|
|
| 2005N-0272
|
| Irradiation in the Production, Processing, and Handling of Food
|
| |
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| 2005V-0145
|
| Laser Light Show
|
| |
|
|
| 2006D-0083
|
| Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
|
| |
|
|
| 2006D-0088
|
| Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
|
| |
|
|
| 2006D-0514
|
| Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
|
| |
|
|
| 2006E-0234
|
| Patent Extension Application for GEM 21S Growth-factor Enhanced Matrix, U.S. Patent No. 5,124,316
|
| |
|
|
| 2006E-0259
|
| Patent Extension Application for X-STOP Interspinous Process Decompression System, U.S. Patent No. 6,235,030
|
| |
|
|
| 2006E-0282
|
| Patent Extension Application for Phakic Intraocular Lenses, U.S. Patent No. 5,192,319
|
| |
|
|
| 2006N-0197
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
|
|
|
|
|
| 2006N-0362
|
| General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
|
| |
|
|
| 2006N-0525
|
| Supplements and Other Changes to an Approved Application
|
| |
|
|
| 2006P-0124
|
| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
|
| |
|
|
| 2006P-0511
|
| Stay any action to grant approval for Oxycodone Hydrochloride extended release tablets, ANDA 77-822
|
| |
|
|
| 2007D-0089
|
| Guidance for Industry and Review Staff on Target Product Profile A Strategic Development Process Tool
|
| |
|
|
| 2007D-0101
|
| Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
|
| |
|
|
| 2007D-0117
|
| Guidance for Industry on Orally Disintegrating Tablets
|
| |
|
|
| 2007E-0011
|
| Patent Extension Application for Lantus (insulin glargine rDNA origin), U.S. Patent No. 5,101,013
|
| |
|
|
| 2007E-0046
|
| Patent Extension Application for ZILMAX (zilpaterol hydrochloride), U.S. Patent No. 4,900,735
|
| |
|
|
| 2007N-0121
|
| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
|
| |
|
|
| 2007N-0179
|
| Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop
|
| |
|
|
| 2007P-0023
|
| Modify the in vitro breakpoints for penicillin and Streptococcus pneumoniae originally set by Clinical and Laboratory Standards Institute
|
| |
|
|
| 2007P-0033
|
| Amend the Nutrition Facts label on food products as it relates to trans fats
|
| |
|
|
| 2007P-0070
|
| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
|
| |
|
|
| 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
|
| |
|
|
| 2007P-0116
|
| Stay any additional Abbreviated New Drug Applications for generic Amlodipine products until after the Mylan Pharmaceuticals Inc. 180-day exclusivity expires on September 23, 2007
|
| |
|
|
| 2007P-0140
|
| Stay final approval and/or effective date of final approval of any 0.4. mg Norethindrone and 35 microgram Ethinyl Estradiol oral chewable tablet product ANDAs unless there is pharmaceutical e
|
| |
|
|
| 2007P-0147
|
| Use of the Term Natural Consistent with USDA's Food Safety and Inspection Service
|
|
| | | | | | | | |
|
| |
|
| 2007P-0194
|
| ANDA Suitability for Acetaminophen, Butalbital, Caffeine and Hydrocodone Bitartrate Capsules
|
|
| |
|
| 1977N-0094L
|
| Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
|
|
|
|
|
|
| | |
|
|
| EREG 2
|
| K. Atkins
|
| Vol #:
|
| 1
|
| |
|
|
| EREG 3
|
| American Academy of Pediatrics
|
| Vol #:
|
| 1
|
| |
|
|
| EREG 4
|
| American Pharmacists Association
|
| Vol #:
|
| 1
|
| |
|
|
| 1981N-0033P
|
| Antigingivitis & Antiplaque-Related Claims
|
| |
|
|
| C 28
|
| 3M ESPE, OMNI Preventive Care
|
| Vol #:
|
| 86
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| EMC 4446
|
| B. Skaggs
|
| Vol #:
|
| 320
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| EMC 694
|
| A. Rae
|
| Vol #:
|
| 24
|
| |
|
|
| EMC 695
|
| L. Goldstein
|
| Vol #:
|
| 24
|
| |
|
|
| EMC 696
|
| S. Thie
|
| Vol #:
|
| 24
|
| |
|
|
| EMC 697
|
| K. Orndorff
|
| Vol #:
|
| 24
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC 815
|
| Mission Possible International
|
| Vol #:
|
| 11
|
| |
|
|
| EMC 816
|
| Mission Possible International
|
| Vol #:
|
| 11
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC 1494
|
| K. Rafferty
|
| Vol #:
|
| 12
|
| |
|
|
| EMC 1495
|
| No Signature
|
| Vol #:
|
| 12
|
| |
|
|
| EMC 1496
|
| M. Wilson
|
| Vol #:
|
| 12
|
| |
|
|
| EMC 1497
|
| J. Hull
|
| Vol #:
|
| 12
|
|
| |
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
| |
|
|
| EMC 526
|
| K. Gough
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 527
|
| A. Rau
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 528
|
| J. Machado
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 529
|
| L. Homer
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 530
|
| M. Erway
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 531
|
| M. Steiskal
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 532
|
| J. Teton
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 533
|
| W. Lewis
|
| Vol #:
|
| 96
|
|
| | | | | | | |
|
| |
|
| EMC 534
|
| R. Cushing
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 535
|
| C. Fuenzalida
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 536
|
| M. Mattingly
|
| Vol #:
|
| 96
|
|
| |
|
| EMC 537
|
| R. Aviles
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 538
|
| P. Myers
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 539
|
| R. Catipon
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 540
|
| B. Flowers
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 541
|
| G. Popken
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 542
|
| W. Oliver
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 543
|
| M. Gumble
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 544
|
| G. Sosnowsky
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 545
|
| F. Kuharcik
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 546
|
| J. Brinkert
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 547
|
| D. Valletta
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 548
|
| O. Obabunmi
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 549
|
| S. Clark
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 550
|
| J. Schuyler
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 551
|
| D. & N. Mindock
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 552
|
| D. Mokma
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 553
|
| C. Greene
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 554
|
| G. Callahan
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 555
|
| W. Smith
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 556
|
| K. Fisk
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 557
|
| T. Knauber
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 558
|
| M. Kirin
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 559
|
| E. Sales
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 560
|
| C. Riehl
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 561
|
| T. Muscatello
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 562
|
| M. Bass
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 563
|
| D. Fischer
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 564
|
| J. Wineburgh
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 565
|
| R. Kunselman
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 566
|
| H. Marks
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 567
|
| L. Browne
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 568
|
| H. Carter
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 569
|
| M. Mullins
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 570
|
| C. McGuffin
|
| Vol #:
|
| 96
|
|
| | | | | | | |
|
| |
|
| EMC 571
|
| M. Tupper
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 572
|
| S. Lampropoulos
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 573
|
| G. Schulte
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 574
|
| J. Rogers
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 575
|
| N. Clark
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 576
|
| J. Hill
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 577
|
| G. Burke
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 578
|
| B. Duncan
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 579
|
| V. Rowley
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 580
|
| C. Cook
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 581
|
| J. Ewing
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 582
|
| A. DesPierres
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 583
|
| D. Matesz
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 584
|
| S. Lashley
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 585
|
| W. Oliver
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 586
|
| M. Dantonio
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 587
|
| A. Lyons
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 588
|
| E. Roossien
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 589
|
| S. Smith
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 590
|
| J. Goodman
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 591
|
| S. Krauklis
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 592
|
| N. Sullivan
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 593
|
| J. Pool
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 594
|
| S. Rashall
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 595
|
| P. September
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 596
|
| N. Ross
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 597
|
| R. Wiseman
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 598
|
| W. Wineburgh
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 599
|
| S. Robertson
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 600
|
| J. Calandrelli
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 601
|
| S. Rathke
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 602
|
| B. Jones
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 603
|
| D. Knowles
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 604
|
| R. Zeff
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 605
|
| T. Wittle
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 606
|
| M. Abbott
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 607
|
| J. Hancock
|
| Vol #:
|
| 96
|
|
| | | | | | | |
|
| |
|
| EMC 608
|
| T. & J. Carlson
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 609
|
| C. Cook
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 610
|
| M. Ramsay
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 611
|
| P. Hardin
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 612
|
| P. Mitchell
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 613
|
| R. Rolfe
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 614
|
| A. Taylor
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 615
|
| B. Chiara
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 616
|
| B. Wilhelm
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 617
|
| G. Guizado
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 618
|
| M. Iwasyk
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 619
|
| B. Peroutka
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 620
|
| D. Davidson
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 621
|
| L. Grant
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 622
|
| E. Graves
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 623
|
| S. Morgan
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 624
|
| M. Gardner
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 625
|
| C. Butts
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 626
|
| M. Hirai
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 627
|
| J. Kleinberg
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 628
|
| C. Bell
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 629
|
| K. Harrison
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 630
|
| R. Noomie
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 631
|
| C. Komniey
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 632
|
| J. Debar
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 633
|
| J. Galvan
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 634
|
| J. Kendrick
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 635
|
| E. Hudson
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 636
|
| G. Schettenhelm
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 637
|
| F. Brodley
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 638
|
| S. Muzzey
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 639
|
| C. Anello
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 640
|
| L. Collins
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 641
|
| J. Kahler
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 642
|
| A. Bartholomew
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 643
|
| D. Brown
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 644
|
| S. DuMolin
|
| Vol #:
|
| 96
|
|
| | | | | | | |
|
| |
|
| EMC 645
|
| Bomboubaboubou Jewish Guy
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 646
|
| L. Poulson
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 647
|
| M. Knickerbocker
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 648
|
| J. Rogow
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 649
|
| F. Harrison
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 650
|
| J. Natre
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 651
|
| J. Ervin
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 652
|
| M. Stuart
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 653
|
| S. Briggs
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 654
|
| M. Ellis
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 655
|
| K. McCoy
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 656
|
| C. Schofield
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 657
|
| L. Williams
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 658
|
| M. Hocevar
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 659
|
| S. Herron
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 660
|
| M. Saunders
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 661
|
| S. Machado
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 662
|
| J. Rodgers
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 663
|
| J. Weinberger
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 664
|
| M. Friedman
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 665
|
| D. Brougher
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 666
|
| L. Chilson
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 667
|
| C. Sapan
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 668
|
| M. Louie
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 669
|
| D. Selvege
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 670
|
| L. Salter
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 671
|
| L. Pitner
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 672
|
| J. Anderson
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 673
|
| D. Swiderski
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 674
|
| A. Harris
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 675
|
| G. Schmitz
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 676
|
| D. Jeffrey
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 677
|
| M. Francis
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 678
|
| M. Jackson
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 679
|
| C. Watson
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 680
|
| L. Albino
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 681
|
| D. Davis
|
| Vol #:
|
| 96
|
|
| | | | | | | |
|
| |
|
| EMC 682
|
| C. Vallone
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 683
|
| L. Farrow
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 684
|
| A. Fischer
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 685
|
| S. Dugan
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 686
|
| C. Cummings
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 687
|
| J. McCloskey
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 688
|
| Yorktown Technologies, L. P.
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 689
|
| B. Philion
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 690
|
| B. Anderson
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 691
|
| M. Cada
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 692
|
| V. Zink
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 693
|
| M. Ruiz
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 694
|
| C. Simon
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 695
|
| C. Nelson
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 696
|
| J. Holman
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 697
|
| T. Lawton
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 698
|
| C. Donovan
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 699
|
| D. Lostrom
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 700
|
| M. Domhan
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 701
|
| M. & K. Bennefield
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 702
|
| T. Collins
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 703
|
| D. McGowan
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 704
|
| R. Wiest
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 705
|
| K. Rohrer
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 706
|
| N. Bartol
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 707
|
| L. Barber
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 708
|
| T. Turner
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 709
|
| M. Bacso
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 710
|
| M. Roche
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 711
|
| A. Spektor
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 712
|
| A. Morgan
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 713
|
| S. Dunn
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 714
|
| K. LaFever
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 715
|
| D. Turner
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 716
|
| M. Dertien
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 717
|
| Government of Canada, Canadian Food Inspection Agency, Health Canada
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 718
|
| ViaGen Inc
|
| Vol #:
|
| 96
|
|
| | | | | | | | |
|
| |
|
| EMC 719
|
| Whole Foods Market Inc, CROPP Cooperative
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 720
|
| M. Schacht
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 721
|
| M. Desmond
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 722
|
| G. Gersch
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 723
|
| The Food Policy Institute
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 724
|
| N. Riegsecker
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 725
|
| M. Nauschultz
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 726
|
| G. Saffan
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 727
|
| G. Morresi
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 728
|
| A. Fifield
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 729
|
| K. Turner
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 730
|
| R. Fuller
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 731
|
| R. Demic
|
| Vol #:
|
| 96
|
| |
|
|
| EMC 732
|
| H. Peppard
|
| Vol #:
|
| 96
|
| |
|
|
| 2005D-0112
|
| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
|
| |
|
|
| EC 12
|
| US Army
|
| Vol #:
|
| 1
|
| |
|
|
| EC 13
|
| University of Saskatchewan
|
| Vol #:
|
| 1
|
| |
|
|
| EC 14
|
| Mr. David Ayoubi
|
| Vol #:
|
| 1
|
| |
|
|
| EC 15
|
| Mr. Russell Proulx
|
| Vol #:
|
| 1
|
| |
|
|
| EC 16
|
| Charles S Gannon, MD
|
| Vol #:
|
| 1
|
| |
|
|
| EC 17
|
| Mr. Nicholas Stavriotis
|
| Vol #:
|
| 1
|
| |
|
|
| EC 18
|
| Mr. Warren Scott
|
| Vol #:
|
| 1
|
| |
|
|
| EC 19
|
| Dr. Klaus Baeuerle
|
| Vol #:
|
| 1
|
| |
|
|
| EC 20
|
| Ms. Robert Christie
|
| Vol #:
|
| 1
|
| |
|
|
| EC 21
|
| Mr. D S
|
| Vol #:
|
| 1
|
| |
|
|
| EC 22
|
| N/A
|
| Vol #:
|
| 1
|
| |
|
|
| EC 23
|
| Mr. Brad Wick
|
| Vol #:
|
| 1
|
| |
|
|
| EC 24
|
| Mr. David AYOUBI
|
| Vol #:
|
| 1
|
| |
|
|
| EC 25
|
| Mrs. Judy Benson
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0272
|
| Irradiation in the Production, Processing, and Handling of Food
|
| |
|
|
| EC 292
|
| Ms. Joyce Mahaffy
|
| Vol #:
|
| 6
|
| |
|
|
| EREG 826
|
| J. Haskell
|
| Vol #:
|
| 7
|
| |
|
|
| EREG 827
|
| D. Engisch-Platt
|
| Vol #:
|
| 7
|
| |
|
|
| EREG 828
|
| E. Van Bremen
|
| Vol #:
|
| 7
|
| |
|
|
| EREG 829
|
| V. Scheidler
|
| Vol #:
|
| 7
|
|
| | | | | | | | |
|
| |
|
| EREG 830
|
| L. Schnoor
|
| Vol #:
|
| 7
|
| |
|
|
| EREG 831
|
| E. Waldock
|
| Vol #:
|
| 7
|
| |
|
|
| EREG 832
|
| S. Certo
|
| Vol #:
|
| 7
|
| |
|
|
| EREG 833
|
| A. Kumar
|
| Vol #:
|
| 7
|
| |
|
|
| EREG 834
|
| S. Samnick
|
| Vol #:
|
| 7
|
| |
|
|
| EREG 835
|
| B. Picatti
|
| Vol #:
|
| 7
|
| |
|
|
| EREG 836
|
| B. Rawlinson
|
| Vol #:
|
| 7
|
| |
|
|
| EREG 837
|
| C. Litsey
|
| Vol #:
|
| 7
|
| |
|
|
| EREG 838
|
| M. Clinton
|
| Vol #:
|
| 7
|
| |
|
|
| EREG 839
|
| A. Evans
|
| Vol #:
|
| 7
|
| |
|
|
| EREG 840
|
| T. Cushing
|
| Vol #:
|
| 7
|
| |
|
|
| EREG 841
|
| S. Farmer
|
| Vol #:
|
| 7
|
| |
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| EMC 319
|
| European Commission
|
| Vol #:
|
| 5
|
| |
|
|
| 2005V-0145
|
| Laser Light Show
|
| |
|
|
| ACK 2
|
| FDA/DDM to Disneyland Resort
|
| Vol #:
|
| 1
|
| |
|
|
| VAR 2
|
| Disneyland Resort
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0083
|
| Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
|
| |
|
|
| NAD 2
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| REF 1
|
| References
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0088
|
| Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
|
| |
|
|
| NAD 2
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| REF 1
|
| References
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0514
|
| Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
|
|
|
|
|
|
|
| |
|
|
| EMC 1
|
| Duke University Medical Center-Pediatric Blood and Marrow Transplant Program
|
| Vol #:
|
| 1
|
|
| |
|
| 2006E-0234
|
| Patent Extension Application for GEM 21S Growth-factor Enhanced Matrix, U.S. Patent No. 5,124,316
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0259
|
| Patent Extension Application for X-STOP Interspinous Process Decompression System, U.S. Patent No. 6,235,030
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0282
|
| Patent Extension Application for Phakic Intraocular Lenses, U.S. Patent No. 5,192,319
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2006N-0197
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
|
|
|
|
|
| | |
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0362
|
| General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
|
| |
|
|
| C 9
|
| Premier Cardiothoracic and Vascular Surgeons Inc
|
| Vol #:
|
| 1
|
| |
|
|
| C 10
|
| Duke University Medical Center
|
| Vol #:
|
| 1
|
| |
|
|
| C 11
|
| R Adams Cowley Shock Trauma Center
|
| Vol #:
|
| 1
|
| |
|
|
| C 12
|
| Methodist Hospital
|
| Vol #:
|
| 1
|
|
| |
|
| 2006N-0525
|
| Supplements and Other Changes to an Approved Application
|
| |
|
|
| EMC 4
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0124
|
| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
|
| |
|
|
| EMC 3
|
| ViroPharma Incorporated
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0511
|
| Stay any action to grant approval for Oxycodone Hydrochloride extended release tablets, ANDA 77-822
|
| |
|
|
| EC 4
|
| Ms. chris sandryk
|
| Vol #:
|
| 1
|
| |
|
|
| EC 5
|
| Ms. Kathie Holmes
|
| Vol #:
|
| 1
|
| |
|
|
| WDL 1
|
| Kleinfeld, Kaplan and Becker LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2007D-0089
|
| Guidance for Industry and Review Staff on Target Product Profile A Strategic Development Process Tool
|
| |
|
|
| C 3
|
| Sanofi Aventis US LLC
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 1
|
| Novartis Pharmaceutical Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 2
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
| |
|
|
| 2007D-0101
|
| Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
|
|
|
|
|
|
|
| |
|
|
| C 6
|
| New England Baptist Hospital
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 1
|
| Form Letters (1)
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 2
|
| American Phychiatric Association
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 3
|
| J. Almli
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 4
|
| J. Clemons
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 5
|
| L. Beatty
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 6
|
| E. Arena
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 7
|
| M. Alcorn
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 8
|
| A. Bonvouloir
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 9
|
| M. Belov
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 10
|
| G. Anderson
|
| Vol #:
|
| 7
|
|
| | | | | | | | |
|
| |
|
| EMC 11
|
| B. Bingler
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 12
|
| J. Colgan-Davis
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 13
|
| S. Bhakti
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 14
|
| J. Barlow
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 15
|
| S. Archey
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 16
|
| M. Britton
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 17
|
| M. Bushnell
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 18
|
| T. Aldridge
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 19
|
| S. Chandler
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 20
|
| D. Bohannan
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 21
|
| Merck Research Laboratories
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 22
|
| L. Bagley
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 23
|
| J. Boswell
|
| Vol #:
|
| 3
|
| |
|
|
| 2007D-0117
|
| Guidance for Industry on Orally Disintegrating Tablets
|
| |
|
|
| EC 2
|
| AstraZeneca LP
|
| Vol #:
|
| 1
|
| |
|
|
| 2007E-0011
|
| Patent Extension Application for Lantus (insulin glargine rDNA origin), U.S. Patent No. 5,101,013
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007E-0046
|
| Patent Extension Application for ZILMAX (zilpaterol hydrochloride), U.S. Patent No. 4,900,735
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0121
|
| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
|
| |
|
|
| APE 1
|
| T. Flottman
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 237
|
| Rens, Heidi
|
| Vol #:
|
| 7
|
| |
|
|
| EAPE 238
|
| toth, joyce
|
| Vol #:
|
| 7
|
| |
|
|
| EAPE 239
|
| Taylor, Rebecca
|
| Vol #:
|
| 7
|
| |
|
|
| EAPE 240
|
| Stroup, Timothy
|
| Vol #:
|
| 7
|
| |
|
|
| EAPE 241
|
| Adams, Edgar
|
| Vol #:
|
| 7
|
| |
|
|
| 2007N-0179
|
| Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop
|
| |
|
|
| EC 1
|
| Asset Management LLC
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0023
|
| Modify the in vitro breakpoints for penicillin and Streptococcus pneumoniae originally set by Clinical and Laboratory Standards Institute
|
| |
|
|
| EC 1
|
| Ms. Caroline MIles
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0033
|
| Amend the Nutrition Facts label on food products as it relates to trans fats
|
| |
|
|
| EC 15
|
| Mr. Chris Fogarty
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2007P-0070
|
| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
|
| |
|
|
| EC 43
|
| Mr. Chris Fogarty
|
| Vol #:
|
| 1
|
| |
|
|
| EC 44
|
| Mr. Darren Hawthorne
|
| Vol #:
|
| 1
|
| |
|
|
| EC 45
|
| Mrs. Mary Whitley
|
| 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
|
| |
|
|
| EC 195
|
| Miss. Laura Korbas
|
| Vol #:
|
| 3
|
| |
|
|
| 2007P-0116
|
| Stay any additional Abbreviated New Drug Applications for generic Amlodipine products until after the Mylan Pharmaceuticals Inc. 180-day exclusivity expires on September 23, 2007
|
|
|
|
|
|
|
| |
|
|
| EC 2
|
| Synthon Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 3
|
| Mr. Woody Baker
|
| Vol #:
|
| 1
|
| |
|
|
| EC 4
|
| Heller Ehrman LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0140
|
| Stay final approval and/or effective date of final approval of any 0.4. mg Norethindrone and 35 microgram Ethinyl Estradiol oral chewable tablet product ANDAs unless there is pharmaceutical e
|
|
|
|
|
|
| | |
|
|
| EC 1
|
| Mrs. Caroline Miles
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0147
|
| Use of the Term Natural Consistent with USDA's Food Safety and Inspection Service
|
| |
|
|
| EC 10
|
| Ms. charisse texeira
|
| Vol #:
|
| 2
|
| |
|
|
| EC 11
|
| Ms. Caroline Miles
|
| Vol #:
|
| 2
|
| |
|
|
| EC 12
|
| Mrs. melissa wislon
|
| Vol #:
|
| 2
|
| |
|
|
| EC 13
|
| Mr. Gary Carter
|
| Vol #:
|
| 2
|
| |
|
|
| 2007P-0194
|
| ANDA Suitability for Acetaminophen, Butalbital, Caffeine and Hydrocodone Bitartrate Capsules
|
| |
|
|
| EC 1
|
| Mrs. Tammy Evans
|
| Vol #:
|
| 1
|
|
|
