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Dockets Management

Dockets Entered On July 3, 2006
Table of Contents
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2000D-1306 Content & Format of the Adverse Reactions Section of Labeling
2003D-0478 Guidance on Marketed Unapproved Drugs Compliance Policy Guide
2004D-0343 Hospital Bed System Dimensional Guidance to Reduce Entrapment
2005N-0290 Agency Information Collection Activities: Proposed Collection; Comment Request; Importers Entry Notice
2006D-0191 Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
2006N-0109 General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities
2006P-0124 Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
2006P-0151 Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
2006P-0251 Label change or removal from the market of the psychotropic drug Depakote
2006P-0272 ANDA Suitability for 0.9% Sodium Chloride Injection
2006P-0273 ANDA for Water for Injection, USP, in 3-, 5-, 15-, and 30-mL volumes
2006V-0244 Laser Light Show
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 17970 Sunrider International Vol #: 165
LET 17971 Sunrider International Vol #: 165
LET 17972 Sunrider International Vol #: 165
2000D-1306 Content & Format of the Adverse Reactions Section of Labeling
EC 13 Hoffmann-La Roche, Inc. (Roche) Vol #: 1
2003D-0478 Guidance on Marketed Unapproved Drugs Compliance Policy Guide
EC 25 Mr. Dave Lowe Vol #: 5
EC 26 Mr. Dave Lowe Vol #: 5
2004D-0343 Hospital Bed System Dimensional Guidance to Reduce Entrapment
EC 64 Ms. Judith Hathaway Vol #: 3
2005N-0290 Agency Information Collection Activities: Proposed Collection; Comment Request; Importers Entry Notice
NAL 1 FDA Vol #: 1
2006D-0191 Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
C 2 New Jersey Medical School - UMDNJ Vol #: 1
2006N-0109 General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities
EC 7 Dr. ss ss Vol #: 1
2006P-0124 Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
SUP 2 ViroPharma, Inc. Vol #: 1
2006P-0151 Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
EC 478 Ms. Eleanor Myers Vol #: 3
EC 479 sgi Vol #: 3
EC 480 Ms. Mary McLees-Lane Vol #: 3
EC 481 Ms. Barbara van Davis Vol #: 3
EC 482 University of Rochester Vol #: 3
EC 483 National Association of Social Workers Vol #: 3
EC 484 Mrs. Marci Lackey Vol #: 3
EC 485 Mrs. Rosanna Smith Vol #: 3
EC 486 Pathways Counseling Vol #: 3
EC 487 Mrs. Susan Hunhoff Vol #: 3
EC 488 Mrs. carmen chism Vol #: 3
EC 489 Ms. kristin beamish-brown Vol #: 3
EC 490 Ms. Julia Watson-Frandsen Vol #: 3
EC 491 Mrs. Kathleen Nye Vol #: 3
EC 492 Ms. JUSTINE DEMARI Vol #: 3
EC 493 Dr. Sara Goodkind Vol #: 3
EC 494 Miss. Cassy Ainsworth Vol #: 3
EC 495 NOW Vol #: 3
EC 496 graduate student Vol #: 3
EC 497 Ms. Brittany Debity Vol #: 3
EC 498 Ms. Meredith Baxter Vol #: 3
EC 499 Ms. Amy Miller Vol #: 3
EC 500 Mr. William Bacon Vol #: 3
EC 501 Ms. Carolyn Dethlefson Vol #: 3
EC 502 Ms. Dellana Diovisalvo Vol #: 3
EC 503 Ms. sandra laliberte Vol #: 3
EC 504 Ms. Madeleine Smith Vol #: 3
EC 505 Miss. Christina Gullotto Vol #: 3
EC 506 Ms. Sara Pic-Harrison Vol #: 3
EC 507 Ms. Natasha Borowiak Vol #: 3
EC 508 Mrs. martha boonstra Vol #: 3
EC 509 Mr. Robert Blumenthal Vol #: 3
EC 510 Mrs. Bonnie Ferrill Roman Vol #: 3
EC 511 Ms. Rachel Jones Vol #: 3
EC 512 Ms. Kathleen M. Pape Vol #: 3
EC 513 Ms. Judy Goldsmith Vol #: 3
EC 514 NOW Vol #: 3
EC 515 Ms. Nellie Lee Vol #: 3
EC 516 Ms. Jennifer M Weishaar Vol #: 3
EC 517 Miss. Tina Crema Vol #: 3
EC 518 Miss. Danielle Martin Vol #: 3
EC 519 Ms. Christine Sozanski Vol #: 3
EC 520 Mr. Kevin Riley Vol #: 3
EC 521 Ms. Maricela Renteria Vol #: 3
EC 522 Mr. Joseph Coco Vol #: 3
EC 523 Dr. Mara Berkley Vol #: 3
EC 524 Ms. Vivian Benge Vol #: 3
EC 525 Mrs. Rachel Teanby Vol #: 3
EC 526 Dr. Debra Davis Vol #: 3
EC 527 Mrs. Traci Thomas-Card Vol #: 3
EC 528 Ms. H. Marlene Miller Vol #: 3
EC 529 Ms. Anne Strader Vol #: 3
EC 530 HADC Vol #: 3
EC 531 Ms. Vicki Hoffman Vol #: 3
EC 532 Miss. Michelle Noel Vol #: 3
EC 533 Command Trust Network Vol #: 3
EC 534 Ms. Suzanne Knight Vol #: 3
EC 535 Mrs. Lisa Sklov Vol #: 3
EC 536 cfids of Aamerica Vol #: 3
EC 537 Mrs. Lee Silverstein Vol #: 3
EC 538 Mr. Paul Moss Vol #: 3
EC 539 York Clinical Consulting Vol #: 3
EC 540 Ms. Judith Murphy Vol #: 3
EC 541 Ms. Virginia Baeyens, R.N. Vol #: 3
EC 542 Ms. Emma Williams Vol #: 3
EC 543 Self Help for Equal Rights Vol #: 3
EC 544 Dr. Bernadette McNulty Vol #: 3
EC 545 Ms. Laura Huddlestone Vol #: 3
2006P-0251 Label change or removal from the market of the psychotropic drug Depakote
EC 2 Mr. Dave Lowe Vol #: 1
2006P-0272 ANDA Suitability for 0.9% Sodium Chloride Injection
ACK 1 FDA/DDM to Beckloff Associates Vol #: 1
CP 1 Beckloff Associates, Inc. Vol #: 1
2006P-0273 ANDA for Water for Injection, USP, in 3-, 5-, 15-, and 30-mL volumes
ACK 1 FDA/DDMB to Beckloff Associates Vol #: 1
CP 1 Beckloff Associates Vol #: 1
2006V-0244 Laser Light Show
VRA 1 FDA.CDRH to Cypress Gardens Vol #: 1

Page created on August 14, 2006 kk

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