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Dockets Management
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Dockets Entered On April 21, 2006
Table of Contents
Docket # Title
1995S-0158 Community Disclosure of Institutional Review Boards
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
2003P-0006 Determine if Levorphanol Tartrate withdrawn for safety reaso
2005D-0011 Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products
2005D-0286 Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
2005N-0262 Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
2005N-0285 Current Good Manufacturing Practice Regulation and Investigational New Drugs
2005P-0084 Commercial Brachytherapy Kits for Treatment of Prostate Cancer ; Non-Absorbable Bone Wax ; Non-Absorbable Reformulated "Faux Bone Wax" Needle Plugs
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2005P-0431 Reclassification of P990016 McCue CUBA Clinical Ultrasonic Bone Sonometry System
2006M-0163 H040005 - Karl Storz Semi-Rigid TTTS Fetoscopy Instrument Set, Karl Storz Rigid TTTS Fetoscopy Instrument Set with 0 or 12 degree scope, and Karl Storz Rigid TTTS Fetoscopy Instrument Set with 30 degr
1995S-0158 Community Disclosure of Institutional Review Boards
SUP 50 Northfield Laboratories BB IND #10719 Vol #: 53
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
C 18264 K. Canan Vol #: 516
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
C 12858 K. Canan Vol #: 806
2003P-0006 Determine if Levorphanol Tartrate withdrawn for safety reaso
WDL 1 Lachman Consultant Services, Inc. Vol #: 1
2005D-0011 Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products
C 2 Sanofi-aventis U.S., Inc. Vol #: 1
C 3 Wyeth Pharmaceuticals, Inc. Vol #: 1
C 4 Bristol-Myers Squibb Company (BMS) Vol #: 1
C 5 Bristol-Myers Squibb Company (BMS) Vol #: 1
2005D-0286 Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
C 14 Bristol-Myers Squibb Company (BMS) Vol #: 1
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
CS 10 HFA-305 Vol #: 3
OR 10 HF-3 Vol #: 3
2005N-0262 Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
EC 11 Miss. laurie anspach Vol #: 1
EC 12 i have severe ankylosing spondylitis Vol #: 1
2005N-0285 Current Good Manufacturing Practice Regulation and Investigational New Drugs
C 8 Bristol-Myers Squibb Company (BMS) Vol #: 1
2005P-0084 Commercial Brachytherapy Kits for Treatment of Prostate Cancer ; Non-Absorbable Bone Wax ; Non-Absorbable Reformulated "Faux Bone Wax" Needle Plugs
LET 1 CDRH (HFZ-0001) to World Wide Medical Technologies Vol #: 2
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 6545 M. Dallman Vol #: 90
C 6546 Ms. C. Rasins Vol #: 90
C 6547 T. Scaggs Vol #: 90
C 6548 A. Steffensen Vol #: 90
C 6549 T.C. Montie Vol #: 90
C 6550 R. L. Adams Vol #: 90
C 6551 J. & C. Leiber Vol #: 90
C 6552 L. Constans Vol #: 90
C 6553 H. F. Muller Vol #: 90
C 6554 S. Emerson Vol #: 90
C 6555 S. J. Richards Vol #: 90
C 6556 D. Lazres Vol #: 90
C 6557 M. Folk Vol #: 90
C 6558 M. Nevitt Vol #: 90
C 6559 N. E. Olijslager Vol #: 90
C 6560 C. Sutton Vol #: 90
C 6561 S. Trubitt Vol #: 90
C 6562 S. Brawner Vol #: 90
C 6563 S. Pfrang Vol #: 90
C 6564 R. Smith Vol #: 90
C 6565 D. Fraylick Vol #: 90
C 6566 P. Dimond Vol #: 90
C 6567 D. Johnson Vol #: 90
C 6568 J. Hope Vol #: 90
C 6569 L. Barnette Vol #: 90
C 6570 P. Reed Vol #: 90
C 6571 B. Reiling Vol #: 90
C 6572 J. Reiling Vol #: 90
C 6573 J. Catchpole Vol #: 90
C 6574 E. Crawford Vol #: 90
C 6575 C. Scott Vol #: 90
C 6576 B. Alhadeff Vol #: 90
C 6577 A. Estis-Hudson Vol #: 90
C 6578 N. Carper Vol #: 90
C 6579 Ms. R. L. Malanga Vol #: 90
C 6580 J. Sherrier Vol #: 90
C 6581 J. Whitney Vol #: 90
C 6582 R. A. Hogan Vol #: 90
C 6583 P. O'Connor Vol #: 90
C 6584 B. Hauskins-McElyunn Vol #: 90
C 6585 J. Stevens Vol #: 90
C 6586 G. Arthur Hammons Vol #: 90
C 6587 A. Stoddard Vol #: 90
C 6588 L. Lindsay Vol #: 90
C 6589 S. Walowitz Vol #: 90
C 6590 E. Rivas Vol #: 90
C 6591 E. Rivas Vol #: 90
C 6592 M. Ramos Vol #: 90
C 6593 S. Brutscher Vol #: 90
C 6594 D. Kaliel Vol #: 90
C 6595 A. Panke Vol #: 90
C 6596 A. Sheets Vol #: 90
C 6597 M. H. Maher Vol #: 90
C 6598 L. M. Puckett Vol #: 90
C 6599 J. W. Puckett Vol #: 90
C 6600 D. C. Lewin Vol #: 90
C 6601 A. M. Sherman Vol #: 90
C 6602 L. Miller Vol #: 90
C 6603 M. Schlobohm Vol #: 90
C 6604 B. Session Vol #: 90
C 6605 G. E. Tegl Vol #: 90
C 6606 A. L. Holm Vol #: 90
C 6607 J. Treftz Vol #: 90
C 6608 L.. Anderson Vol #: 90
C 6609 R. Contreras Vol #: 90
C 6610 M. Salsman Vol #: 90
C 6611 K. Schumann Vol #: 90
C 6612 K. Cornell Vol #: 90
C 6613 G. Connor Vol #: 90
C 6614 D. Boynton Vol #: 90
C 6615 B. Prell Vol #: 90
C 6616 P. Wyatt Vol #: 90
C 6617 S. Dines Vol #: 90
C 6618 R. Rayburn Vol #: 90
C 6619 J. Anderson Vol #: 90
C 6620 B. M. Wiggin Vol #: 90
C 6621 J. Biddle Vol #: 90
C 6622 P. Steube Vol #: 90
C 6623 B. Selberg Vol #: 90
C 6624 E. Main Vol #: 90
C 6625 D. Caudell Vol #: 90
C 6626 J. Emmons Vol #: 90
C 6627 T. Goddard Vol #: 90
C 6628 K. Johnson Vol #: 90
C 6629 R. Palins Vol #: 90
C 6630 K. Ravieley Vol #: 90
C 6631 J. Johnson Vol #: 90
C 6632 C. Pickett Vol #: 90
C 6633 P. K. Leach Vol #: 90
C 6634 J. Graves Vol #: 90
C 6635 R. Mishler Vol #: 90
C 6636 J. Bey Vol #: 90
C 6637 S. B. Landis Vol #: 90
C 6638 S. Swanson Vol #: 90
C 6639 M. Braswell Vol #: 90
C 6640 J. Calvano Vol #: 90
C 6641 C. Blanco Vol #: 90
C 6642 C. Blanco Vol #: 90
C 6643 E. Anderson Vol #: 90
C 6644 S. Setter Vol #: 90
C 6645 unreadable Vol #: 90
C 6646 M. Charlesworth Vol #: 90
C 6647 Dr. L. N. Dea Vol #: 90
C 6648 C. Blanco Vol #: 90
C 6649 P. J. Russell Vol #: 90
C 6650 M. Charlesworth Vol #: 90
C 6651 L. Owens Vol #: 90
C 6652 M. Hocksema Vol #: 90
C 6653 L. Baenninger Vol #: 90
2005P-0431 Reclassification of P990016 McCue CUBA Clinical Ultrasonic Bone Sonometry System
LET 1 FDA/CDRH to CooperSurgical, Inc. Vol #: 4
2006M-0163 H040005 - Karl Storz Semi-Rigid TTTS Fetoscopy Instrument Set, Karl Storz Rigid TTTS Fetoscopy Instrument Set with 0 or 12 degree scope, and Karl Storz Rigid TTTS Fetoscopy Instrument Set with 30 degr
AAV 1 Karl Storz Endoscopy-America, Inc. Vol #: 1

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