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Dockets Management
Dockets Entered On May 6, 2005
Table of Contents
Docket # Title
1980N-0208 Biological Products; Bacterial Vaccines and Toxiods
1994P-0036 Req labeling of trans fatty acid & prohibit deceptive claims
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
1999P-4613 Revoke the Regulation That Approved Posilac
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
2002N-0534 Medical Device User Fee and Modernization Act of 2002
2003E-0259 Patent Extension Extension for Geodon or Zeldox (ziprasidone HCl monohydrate), 4,831,031
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003N-0161 Medical Devices;Reprocessed Single-Use Devices;Termination
2003P-0121 Enforcing the patent certification requirements in FD&C Act
2003P-0544 Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
2004D-0487 Guidance for Industry: Dietary Supplement Labeling Guide
2004D-0510 Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
2004N-0217 Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids)
2004N-0454 Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
2004N-0456 Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
2004N-0469 Agency Information Collection Activities: Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
2004P-0290 Refrain from approving any ANDA for a topical mupirocin calcium product containing the amorphous form of the active ingredient
2004P-0351 Change the labeling and take further action to address the association of Viagra (Sildenafil) use and increased STD transmission, including HIV infection
2004P-0488 Refrain from receiving, reviewing, and approving any ANDA for a nasal mupirocin calcium product that contains the amophous form of the active pharmaceutical ingredient.
2004Q-0151 Qualified Health Claim (QHC): soy protein and cancer
2005D-0056 Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular a
2005D-0103 Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
2005P-0048 Professional labeling for aspirin dosing in order to specify the morefavorable benefit/risk profile of aspirin doses of 75-150 mg/day for secondary cardiovascular prevention, 5-=150 mg/day for seconda
2005P-0076 OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
2005P-0170 ANADA for a generic ivermectin soft chew that differs in dosage form for horses
1980N-0208 Biological Products; Bacterial Vaccines and Toxiods
EMC 224 No signature Vol #: 156
EMC 225 D. Kline Vol #: 156
EMC 226 No signature Vol #: 156
1994P-0036 Req labeling of trans fatty acid & prohibit deceptive claims
EMC 551 International Dairy Foods Assn (IDFA) Vol #: 76
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
RPT 269 Giuliani SpA Vol #: 200
RPT 270 Shannon Minerals Ltd Vol #: 202
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 16088 The Lifestyles Group, Ltd. Vol #: 142
LET 16089 Enzymatic Therapy Vol #: 142
LET 16090 Enzymatic Therapy Vol #: 142
LET 16091 Lifeline Therapeutics, Inc. Vol #: 142
LET 16092 Botanical Laboratories Vol #: 142
LET 16093 Enzymatic Therapy Vol #: 142
LET 16094 Enzymatic Therapy Vol #: 142
LET 16095 Source Naturals Vol #: 142
LET 16096 Melaleuca, Inc. Vol #: 142
LET 16097 Melaleuca, Inc. Vol #: 142
LET 16098 Melaleuca, Inc. Vol #: 142
LET 16099 Melaleuca, Inc. Vol #: 142
LET 16100 Jarrow Formulas Vol #: 142
LET 16101 Jarrow Formulas Vol #: 142
LET 16102 Jarrow Formulas Vol #: 142
LET 16103 Enzymatic Therapy Vol #: 142
LET 16104 Enzymatic Therapy Vol #: 142
LET 16105 Enzymatic Therapy Vol #: 142
LET 16106 Gelita Health Products USA, Inc. Vol #: 142
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
EMC 4315 J. Shumaker Vol #: 320
EMC 4316 A. Gackowski Vol #: 320
EMC 4317 N and R Mulliez Vol #: 320
EMC 4318 W. Lochner Vol #: 320
EMC 4319 K. Zimmerman Vol #: 320
EMC 4320 A. Movilla Vol #: 320
EMC 4321 J. Vries Vol #: 320
EMC 4322 K. Ernst Vol #: 320
EMC 4323 C. Mizerany Vol #: 320
1999P-4613 Revoke the Regulation That Approved Posilac
EMC 2428 L. Jones Vol #: 46
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 14414 A. Mulligan Vol #: 342
EMC 14415 H. Sobel Vol #: 342
EMC 14416 E. Hilker Vol #: 342
EMC 14417 M. Langley Vol #: 342
EMC 14418 A. Butler Vol #: 342
EMC 14419 T. McGee Vol #: 342
EMC 14420 G. Martin Vol #: 342
EMC 14421 J. Sitrick, Jr. Vol #: 342
EMC 14422 T. Verdery Vol #: 342
EMC 14423 T. Haberkorn Vol #: 342
EMC 14424 K. Delaney Vol #: 342
EMC 14425 K. Jelke Vol #: 342
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
EMC 1260 E. Ho Vol #: 5
EMC 1261 L. Hitt Vol #: 5
2002N-0534 Medical Device User Fee and Modernization Act of 2002
C 39 Ass of Medical Device Reprocessors (AMDR) Vol #: 2
2003E-0259 Patent Extension Extension for Geodon or Zeldox (ziprasidone HCl monohydrate), 4,831,031
N 1 FDA Vol #: 1
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 778 M. Bortz Vol #: 11
EMC 779 M. Essary, R.N. Vol #: 11
2003N-0161 Medical Devices;Reprocessed Single-Use Devices;Termination
C 5 Ass of Medical Device Reprocessors (AMDR) Vol #: 1
2003P-0121 Enforcing the patent certification requirements in FD&C Act
LET 2 Biovail Corporation Vol #: 1
2003P-0544 Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
C 41 M. Anstadt, RN,C Vol #: 5
2004D-0487 Guidance for Industry: Dietary Supplement Labeling Guide
C 1 R. Fucetola, JD Vol #: 1
2004D-0510 Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
C 13 Honorable Rob Simmons Vol #: 1
2004N-0217 Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids)
C 3 Shape Up America Vol #: 3
C 4 American Institute for Cancer Research Vol #: 3
C 5 Advocates for better Children's diets Vol #: 3
2004N-0454 Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
EMC 1112 C. Vallone Vol #: 29
EMC 1113 J. Murray Vol #: 29
EMC 1114 P. McMakin Vol #: 29
EMC 1115 K. Woolsey Vol #: 29
EMC 1116 B. Labant Vol #: 29
EMC 1117 M. MacDonald Vol #: 29
EMC 1118 L. Rahn Vol #: 29
EMC 1119 M. Steiskal Vol #: 29
EMC 1120 D. Bellamy Vol #: 29
EMC 1121 P. Curtis Vol #: 29
EMC 1122 A. Sather Vol #: 29
EMC 1123 R. Dale Vol #: 29
EMC 1124 W. West Vol #: 29
EMC 1125 T. Hughes Vol #: 29
EMC 1126 S. Ferguson Vol #: 29
EMC 1127 G. Ehnert Vol #: 29
EMC 1128 J. Conklin Vol #: 29
EMC 1129 W. Zink Vol #: 29
EMC 1130 H. Rush Vol #: 29
EMC 1131 O. Selfridge Vol #: 29
EMC 1132 B. Stevens Vol #: 29
EMC 1133 M. Grafious Vol #: 29
EMC 1134 J. Hartman Vol #: 29
EMC 1135 J. Servilio Vol #: 29
EMC 1136 R. Bennett Vol #: 29
EMC 1137 A. Kelly Vol #: 29
EMC 1138 A. Hudak Vol #: 29
EMC 1139 J. Gold Vol #: 29
EMC 1140 H. Stafford Vol #: 29
EMC 1141 J. Maggio Vol #: 29
EMC 1142 S. Harris Vol #: 29
EMC 1143 D. Toepfer Vol #: 29
EMC 1144 D. Crowley Vol #: 29
EMC 1145 N. Adams Vol #: 29
EMC 1146 T. Hicks Vol #: 29
EMC 1147 D. Campfield Vol #: 29
EMC 1148 C. Pervier Vol #: 29
EMC 1149 D. Beaty Vol #: 29
EMC 1150 J. Breeze Vol #: 29
EMC 1151 J and E Logan Vol #: 29
2004N-0456 Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
EC 3 Mr. larry watts Vol #: 6
EC 4 Mr. Joe Citizen Vol #: 6
EC 5 GMA Vol #: 6
EC 6 Ms. rebecca gukaylo Vol #: 6
EC 7 Mrs. Mayuko Brumfield Vol #: 6
EC 8 Mrs. Andrea Fease Vol #: 6
EC 9 Mr. Mitchell Li Vol #: 6
EC 10 Miss. Katharine Zandy Vol #: 6
2004N-0469 Agency Information Collection Activities: Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
EMC 1 B. Sachau Vol #: 1
2004P-0290 Refrain from approving any ANDA for a topical mupirocin calcium product containing the amorphous form of the active ingredient
SUP 3 GlaxoSmithKline Vol #: 1
2004P-0351 Change the labeling and take further action to address the association of Viagra (Sildenafil) use and increased STD transmission, including HIV infection
C 9 Men's HealthNetwork (MHN) Vol #: 1
2004P-0488 Refrain from receiving, reviewing, and approving any ANDA for a nasal mupirocin calcium product that contains the amophous form of the active pharmaceutical ingredient.
SUP 3 GlaxoSmithKline Vol #: 1
2004Q-0151 Qualified Health Claim (QHC): soy protein and cancer
EC 420 Mrs. Nancy Karlov Vol #: 8
EC 421 Mrs. Charlotte Thomas Vol #: 8
EC 422 Mrs. Eugenia Zanone Vol #: 8
EC 423 Greenstar Vol #: 8
EC 424 Mr. Ike Wiley Vol #: 8
EC 425 Mr. Robert Cannon Vol #: 8
EC 426 Mrs. Nancy Lade Vol #: 8
EC 427 Mr. Guy Shashaty Vol #: 8
EC 428 Mr. Donald Butler Vol #: 8
EC 429 Mrs. Hazel Lake Vol #: 8
EC 430 Mr. andrew rumberger Vol #: 8
EC 431 Dr. Richard Linchitz Vol #: 8
EC 432 Mr. Robert Bilas Vol #: 8
EC 433 Mr. Ray Dudley Vol #: 8
EC 434 Mr. Luis Sanchez Vol #: 8
EC 435 Mr. David Miller Vol #: 8
EC 436 Mrs. Ann Fuller Vol #: 8
EC 437 Mrs. diana glotfelty Vol #: 8
EC 438 Ms. Ann Ferris Vol #: 8
EC 439 Ms. Anita Kessler Vol #: 8
EC 440 Mrs. DEBRA WRIGHT Vol #: 8
EC 441 Mr. James S. Wheeler Vol #: 8
EC 442 Mr. John Du Ban Vol #: 8
EC 443 Mrs. Sue Stone Vol #: 8
EC 444 Mrs. Nell Danielson Vol #: 8
EC 445 Mr. Werner Mainka Vol #: 8
EC 446 Mr. Leo Huggins Vol #: 8
EC 447 Mrs. Donna Budnick Vol #: 8
EC 448 Mr. Jerry K Smith Vol #: 8
EC 449 Mr. Dennis Wodzinski Vol #: 8
EC 450 Mr. Kenneth Hankin Vol #: 8
EC 451 Mrs. Brenda Urick Vol #: 8
EC 452 Ms. Barbara Boardman Vol #: 8
EC 453 Mr. Gary Strompf Vol #: 8
EC 454 Consultant Vol #: 8
EC 455 Mr. Jesse Thompson, II Vol #: 8
EC 456 Mr. Sidney Lida Vol #: 8
EC 457 Independent Research Vol #: 8
EC 458 Ms. Rhonda Stein Vol #: 8
EC 459 Mr. Keith Bekaert Vol #: 8
EC 460 Mr. Jeffery Vernon Vol #: 8
EC 461 Mr. fred riepen Vol #: 8
EC 462 Ms. Lisa Copeland Vol #: 8
EC 463 Ms. Ramona Leahy Vol #: 8
EC 464 Mr. John Davis Jr Vol #: 8
EC 465 Ms. w r stratford jr Vol #: 8
EC 466 Mr. John Davis Vol #: 8
EC 467 Mrs. Barbara Sayers Vol #: 8
EC 468 Dr. Sean Brady Vol #: 8
EC 469 Mr. John Gardner Vol #: 8
EC 470 Ms. Dorothy Davis Vol #: 8
EC 471 Mr. COY WYATT Vol #: 8
EC 472 Mr. Gilbert Buccola Vol #: 8
EC 473 Mrs. S. Brocke Vol #: 8
EC 474 Dr. John Pannone Vol #: 8
EC 475 Dr. Joseph Valese Vol #: 8
EC 476 Mr. Ed Coenen Vol #: 8
EC 477 Science Teacher Vol #: 8
EC 478 Mr. ANTHONY SETTINERI Vol #: 8
EC 479 Dr. Ines Carrasquillo Vol #: 8
EC 480 Mr. David Samsky Vol #: 8
EC 481 Mrs. Karen Hubbard Vol #: 8
EC 482 Mrs. Kara Jarman Vol #: 8
EC 483 Mr. Cecil Jarman Vol #: 8
EC 484 Mrs. Sandra Jones Vol #: 8
EC 485 Mrs. Esther Hebert Vol #: 8
EC 486 Mr. daniel killmeyer Vol #: 8
EC 487 Mrs. Deb Fett Vol #: 8
EC 488 Mr. Allen Stupplebeen Vol #: 8
EC 489 Mr. Jonathan Elwell Vol #: 8
EC 490 Ms. Jannette Murray Vol #: 8
EC 491 Mr. Donald Lohr Vol #: 8
EC 492 Mr. Roy Jones Vol #: 8
EC 493 Mr. James Bowe Vol #: 8
EC 494 Mrs. Sharon Rehorn Vol #: 8
EC 495 Mrs. Natalie Sullivan Vol #: 8
EC 496 Mr. casey pera Vol #: 8
EC 497 Mr. Richard Brehm Vol #: 8
EC 498 Mr. Rich Granier Vol #: 8
EC 499 Ms. Regina Cunningham Vol #: 8
EC 500 Mr. Herb Hill Vol #: 8
EC 501 Mrs. Linda Walcroft Vol #: 8
EC 502 Dr. James Midgley Vol #: 8
EC 503 Mrs. Patricia Ginther Vol #: 8
EC 504 Mr. James McEwan Vol #: 8
EC 505 Miss. Heather Jerrett Vol #: 8
EC 506 Miss. erika christensen Vol #: 8
EC 507 Mrs. c fuller Vol #: 8
EC 508 Mr. Marty Howe Vol #: 8
EC 509 Mr. James C Brown Vol #: 8
EC 510 Mr. Duane McMurdie Vol #: 8
EC 511 Ms. Polly Campbell Vol #: 8
EC 512 Ms. Linda Peterson Vol #: 8
EC 513 Mr. EDWARD MULIGAN Vol #: 8
EC 514 Mrs. Sandra Juancito Vol #: 8
EC 515 Mr. Allen Thurber Vol #: 8
EC 516 Mr. Kenneth Wilson Vol #: 8
EC 517 Mr. Tom Onusaitis Vol #: 8
EC 518 Mr. Steven Cormier Vol #: 8
EC 519 Ms. Theo Szurek Vol #: 8
EC 520 Mr. Patrick Young Vol #: 8
EC 521 Ms. Elizabeth Lonergan Vol #: 8
EC 522 Ms. Christine Schaefer Vol #: 8
EC 523 Ms. Elisa Rudd Vol #: 8
EC 524 Mrs. Shawn Wells Vol #: 8
EC 525 Mr. Neil Dodson Vol #: 8
EC 526 Ms. Suzanne Bundy Vol #: 8
EC 527 Ms. Melody Walters Vol #: 8
EC 528 Mrs. Karen Mayberry Vol #: 8
EC 529 Mrs. Roberta Sandelli Vol #: 8
EC 530 Mr. Robert Drewry Vol #: 8
EC 531 Mr. h Buxton II Vol #: 8
EC 532 Mr. Stephen Kolasa Vol #: 8
EC 533 Mr. Mike Harrold Vol #: 8
EC 534 Miss. Kate Hoth Vol #: 8
EC 535 Mrs. Diane Weigel Vol #: 8
EC 536 Mrs. Michelle Malloch Vol #: 8
EC 537 Mr. Bill Harrison Vol #: 8
EC 538 Mrs. Debra Turner Vol #: 8
EC 539 Mr. Dave Lawson Vol #: 8
EC 540 Mrs. Kathleen Bourque Vol #: 8
EC 541 Mr. Brad Saffell Vol #: 8
EC 542 Mrs. Diane Purser Vol #: 8
EC 543 Ms. Charli sorenson Vol #: 8
EC 544 Mr. Gregory Hansen Vol #: 8
EC 545 Ms. Beverly Greenlee Vol #: 8
EC 546 Ms. Jan Berg Vol #: 8
EC 547 Mrs. Kelly Cirillo Vol #: 8
EC 548 Mr. Arthur Slate Vol #: 8
EC 549 Mr. Randall Marshall Vol #: 8
EC 550 Mr. Douglas Whitstone Vol #: 8
EC 551 Mrs. AnnMarie Gazsi Vol #: 8
EC 552 Mr. Randolph Jonsson Vol #: 8
EC 553 Ms. Jane Breazzano Vol #: 8
EC 554 Ms. Pat Hollister Vol #: 8
EC 555 Mr. andrew morley Vol #: 8
EC 556 Mrs. Linda Hinchey Vol #: 8
EC 557 Homeopathic study Group Vol #: 8
EC 558 Mrs. Andrea Bassette Vol #: 8
EC 559 Mrs. Kathy Kurosky Vol #: 8
EC 560 Ms. Charlotte Hiserote Vol #: 8
EC 561 Ms. Vivian Brandon Vol #: 8
EC 562 Mrs. MALINDA DAHLIN Vol #: 8
EC 563 Mr. Steven Busey Vol #: 8
EC 564 Ms. J Jackson Vol #: 8
EC 565 Mrs. Alberta Pieper Vol #: 8
EC 566 Dr. DORIS SIDELEAU Vol #: 8
EC 567 Mr. John Dyki Vol #: 8
EC 568 Mrs. Karen Janke Vol #: 8
EC 569 Mrs. Shawn Dady Vol #: 8
EC 570 Ms. Charlotte Weiland Vol #: 8
EC 571 Mrs. Juanita A. Rothrock Vol #: 8
EC 572 Dr. FRANK CUNS-RIAL Vol #: 8
EC 573 Ms. Judith Strazzera Vol #: 8
EC 574 Miss. Vivian Elliott Vol #: 8
EC 575 Dr. David Kightley Vol #: 8
EC 576 Mr. Sean Sullivan Vol #: 8
EC 577 Ms. Sonja Warnock Vol #: 8
EC 578 Ms. Lori Kozlowski Vol #: 8
EC 579 Dr. Gerald Dinerman Vol #: 8
EC 580 Mr. Ben Sharp Vol #: 8
EC 581 Ms. Deborah Idol Vol #: 8
EC 582 Ms. Judy Nuss Vol #: 8
EC 583 Ms. Barbara Zarrella Vol #: 8
EC 584 Mr. Lawrence Cassada Jr Vol #: 8
EC 585 Mrs. Michele Garrison Vol #: 8
EC 586 Ms. djean degara Vol #: 8
EC 587 Ms. Victoria Jahn Vol #: 8
EC 588 NA Vol #: 8
EC 589 Dr. Diamond Emmanuel Vol #: 8
EC 590 Mrs. Deborah Leggett Vol #: 8
EC 591 Mrs. Beth Heltsley Vol #: 8
EC 592 Mr. Robert Chevako Vol #: 8
EC 593 Ms. Tamera Nowicki Vol #: 8
EC 594 Ms. Ronny Wheeler Vol #: 8
EC 595 Mr. George Santana Vol #: 8
EC 596 Mrs. Kathleen Zurolo Vol #: 8
EC 597 Mrs. Justina Duncan Vol #: 8
EC 598 Mrs. Nicole Boyd Vol #: 8
EC 599 Mr. Scott Inman Vol #: 8
EC 600 Pearl Acupuncture Vol #: 8
EC 601 Ms. Janet Mielke Vol #: 8
EC 602 Mr. Robert Rogers Vol #: 8
EC 603 Mr. Earl Wright Vol #: 8
EC 604 Mrs. Carolyn Johnson Vol #: 8
EC 605 Mr. Wayne Robinson Vol #: 8
EC 606 Megalo Media Vol #: 8
EC 607 Mrs. Stephanie Jordan Vol #: 8
EC 608 Ms. Karen Siegel Vol #: 8
EC 609 Miss. Estibaliz Milam Vol #: 8
EC 610 Ms. Elizabeth Valsala Vol #: 8
EC 611 Mr. Robert Jackson Vol #: 8
EC 612 Mrs. Connie Schmitt Vol #: 8
EC 613 Mrs. Rox Cook Vol #: 8
EC 614 homemaker Vol #: 8
EC 615 Mrs. Nicole Radigan Vol #: 8
EC 616 Mrs. Marilyn Horak Vol #: 8
EC 617 Mrs. Linda Browne Vol #: 8
EC 618 Ms. Richard Zuckerman Vol #: 8
EC 619 Mrs. Machiko Capo Vol #: 8
EC 620 Mrs. Helen Engbring Vol #: 8
EC 621 Ms. Patricia Zanon Vol #: 8
EC 622 N/A Vol #: 8
EC 623 Mrs. Patricia A Wedegis Vol #: 8
EC 624 Ms. Donna Lopez Vol #: 8
EC 625 Ms. Isabel Papagno Vol #: 8
EC 626 Mr. M Mrazek Vol #: 8
EC 627 Mrs. Ruth Ann Foster Vol #: 8
EC 628 Mrs. Jody Franks Vol #: 8
EC 629 Ms. Carol Pawlak Vol #: 8
EC 630 Mr. Jared Rench Vol #: 8
EC 631 Mrs. erica bullard Vol #: 8
EC 632 Hamilton Bradley Center for Wellness and Rehab. Vol #: 8
EC 633 Miss. KERRY COOK Vol #: 8
EC 634 Weston A. Price Foundation Vol #: 8
EC 635 Weston A. Price Foundation Vol #: 8
EC 636 Ms. Susan Kreider, RN, CPC Vol #: 8
EC 637 Mr. Howard Hamilton Vol #: 8
EC 638 Ms. J Wexler Vol #: 8
EC 639 Ms. Geraldine Hraban Vol #: 8
2005D-0056 Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular a
SUP 1
Attachment 		American Society for Reproductive Medicine (ASRM) and Society for Assisted Reproductive Tech (SA Vol #: 1
2005D-0103 Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
C 3 Methapharm, Inc. Vol #: 1
2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
C 13 Council on Government Relations (COGR) Vol #: 3
C 14 Scripps Cancer Center Institutional Review Board Vol #: 3
C 15 Scripps Cancer Center Institutional Review Board Vol #: 3
2005P-0048 Professional labeling for aspirin dosing in order to specify the morefavorable benefit/risk profile of aspirin doses of 75-150 mg/day for secondary cardiovascular prevention, 5-=150 mg/day for seconda
C 1 American College of Gastroenterology Vol #: 1
C 2 Bayer HealthCare Consumer Care Division Vol #: 3
2005P-0076 OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
C 1 Purdue Pharma LP Vol #: 1
2005P-0170 ANADA for a generic ivermectin soft chew that differs in dosage form for horses
ACK 1 HFA-305 to Intervet Inc. Vol #: 1
CP 1 Intervet Inc. Vol #: 1

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