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97N-0314 Prescription Drug Products; Levothyroxine Sodium * 98P-0680 Amend reg re: sale & distribution of turtles & viable eggs * 00D-1598 Voluntary Labeling for Bioengineered Foods * 00N-1396 Bioengineered Foods Consumed By Humans or Animals * 00P-1322 Food Labeling and Allergen Contamination Control * 01D-0025 Guidance for Industry - Yellow Corn & Dry-Milled * 01N-0197 Treatment of Ankylosing Spondylitis and Related Disorders * 01P-0061 Request to file an ANDA for Ifosfamide for Injection * 01P-0320 Establish Format Standards for Ingredient Labels on Food Pro * |
97N-0314 Prescription Drug Products; Levothyroxine Sodium
C 4 Edy Rudnick Pineless Vol#: 1
97N-484R Human Cellular and Tissue-Based Products
NAL 2 Vol#: 7
SS 1 SUPPORTING STATEMENT Vol#: 7
98D-0362 Stability Testing of Drug Substances and Drug Products
C 74 Pharm Research and Manuf of America Vol#: 5
98P-0680 Amend reg re: sale & distribution of turtles & viable eggs
C 22 Zzara Foust Vol#: 1
99F-2533 Listed Gum or Wood Rosin Derivatives
FONS1 Findings of No Significant Impact Vol#: 1
NFR 1 Vol#: 1
99N-1168 Public Health Impact of Foodborne Listeria Monocytogenes
C 17 Food Marketing Institute Vol#: 21
00D-0084 Special Protocol Assessment
NAL 1 Supporting Statement Vol#: 1
SS 1 Supporting Statement Vol#: 1
00D-1598 Voluntary Labeling for Bioengineered Foods
C 5837 Leslie Birkenstock Vol#: 406
C 5838 Wendy Schmitt Vol#: 406
C 5839 Gerry Mutuski Vol#: 406
C 5840 Dawn Mutuski Vol#: 406
C 5841 Jeanne Dodds Vol#: 406
C 5842 Cheri Wissenbach Vol#: 406
C 5843 Glenn Kirciler Vol#: 406
C 5844 Stephen Lane Vol#: 406
C 5845 No Signature Vol#: 406
C 5846 No Signature Vol#: 406
C 5847 Wade Skeels Vol#: 406
C 5848 Kevin J. Anderson Vol#: 406
C 5849 Steven & Jean Dropkin Vol#: 406
C 5850 Allsyn Kiplinger Vol#: 406
C 5851 Carol Kiplinger Vol#: 406
C 5852 Jackie Kypta Vol#: 406
C 5853 John Keith Vol#: 406
C 5854 Stan Stroh Vol#: 406
C 5855 Diane C. Beeny Vol#: 406
C 5856 Jen Ardris Vol#: 406
C 5857 Barbara Braudler Vol#: 406
C 5858 Jean Garrick Vol#: 406
C 5859 Paul F. Cunningham Vol#: 406
C 5860 Kim Newman Vol#: 406
C 5861 C. Duran Vol#: 406
C 5862 Meenakshi Jkis Vol#: 406
C 5863 Debbie Tannenbanm Vol#: 406
C 5864 Suzanne Wuerthele Vol#: 406
C 5865 Nancy Harris Vol#: 406
C 5866 Heather McAlpir Vol#: 406
C 5867 J. Mel Harris Vol#: 406
C 5868 Miriam Z. Grynberg Vol#: 406
C 5869 Leslie Wildesen Vol#: 406
C 5870 Mary R. Odino Vol#: 406
C 5871 Kristine Gionson Vol#: 406
C 5872 Lisa S. Rowe Vol#: 406
C 5873 Kimberly P. Larsen Vol#: 406
C 5874 Bob Legge Vol#: 406
C 5875 Mary Chapman Vol#: 406
C 5876 Amy Leffel Vol#: 406
C 5877 Lisa Grimardi Vol#: 406
C 5878 Glen Patrick Vol#: 406
C 5879 Edith Malin Vol#: 406
C 5880 Shanti Green Vol#: 406
C 5881 Magnus Homestead Vol#: 406
C 5882 Jamie Gilmore Vol#: 406
C 5883 Brooke Benoit Vol#: 406
C 5884 Steve Vol#: 406
C 5885 Chris Spalding Vol#: 406
C 5886 Ed Kucha Vol#: 406
C 5887 Julia Driks Vol#: 406
C 5888 Julia Driks Vol#: 406
C 5889 Clyde R. Chamberlain Jr. Vol#: 406
C 5890 Deborah Bannett Vol#: 406
C 5891 Barbara Shaheen Vol#: 406
EMC 9672 Mary Pitts Vol#: 407
EMC 9673 Joanne McVicker Vol#: 407
EMC 9674 Amy Zezulka Vol#: 407
EMC 9675 Roberta Dunderdale Vol#: 407
EMC 9676 James Ehrlich Vol#: 407
EMC 9677 Christopher Robertson Vol#: 407
EMC 9678 Christopher Robertson Vol#: 407
EMC 9679 Ovadia Yesodi Vol#: 407
EMC 9680 Ovadia Yesodi Vol#: 407
EMC 9681 Karen Olch Vol#: 407
EMC 9682 Karen Olch Vol#: 407
EMC 9683 Cecily Andrews Vol#: 407
EMC 9684 Cecily Andrews Vol#: 407
EMC 9685 Debora Goldstein Vol#: 407
EMC 9686 Debora Goldstein Vol#: 407
EMC 9687 Gregory Campbell Vol#: 407
EMC 9688 Elizabeth Croteau Vol#: 407
EMC 9689 Elizabeth Croteau Vol#: 407
EMC 9690 Elvira Niles Vol#: 407
EMC 9691 Elvira Niles Vol#: 407
EMC 9692 Richard Bischoff Vol#: 407
EMC 9693 Richard Bischoff Vol#: 407
EMC 9694 Irl Nelson Staloup Vol#: 407
EMC 9695 Irl Nelson Staloup Vol#: 407
EMC 9696 Christopher Campbell Vol#: 407
EMC 9697 Christopher Campbell Vol#: 407
EMC 9698 Steven Landau Vol#: 407
EMC 9699 Steven Landau Vol#: 407
EMC 9700 Michael Benowich Vol#: 407
EMC 9701 Michael Benowich Vol#: 407
EMC 9702 Steve Cater Vol#: 407
EMC 9703 Fred Schneider Vol#: 407
EMC 9704 Fred Schneider Vol#: 407
EMC 9705 Rebekah Leonhart Vol#: 407
EMC 9706 Rebekah Leonhart Vol#: 407
EMC 9707 Jennifer Maloney Vol#: 407
EMC 9708 Gus Steeves Vol#: 407
EMC 9709 Gus Steeves Vol#: 407
EMC 9710 Samantha Wanat Vol#: 407
EMC 9711 Samantha Wanat Vol#: 407
EMC 9712 Ivars Ikstrums Vol#: 407
EMC 9713 Karen Cole Huttlinger Vol#: 407
EMC 9714 Peggy Swsweeney Vol#: 407
EMC 9715 Peggy Swsweeney Vol#: 407
EMC 9716 Carrie Gorr Vol#: 407
EMC 9717 Carrie Gorr Vol#: 407
EMC 9718 Christopher Martinez Vol#: 407
EMC 9719 Anne Eller Vol#: 407
EMC 9720 Anne Eller Vol#: 407
EMC 9721 Lynn Leeds Vol#: 407
EMC 9722 number not used Vol#: 407
EMC 9723 number not used Vol#: 407
EMC 9724 number not used Vol#: 407
EMC 9725 Duke Mangione Vol#: 407
EMC 9726 Duke Mangione Vol#: 407
EMC 9727 Caroline Brock Vol#: 407
EMC 9728 Patricia L. Morris Vol#: 407
EMC 9729 Ruth Kearley Vol#: 407
EMC 9730 Ruth Kearley Vol#: 407
EMC 9731 Averie Clark Vol#: 407
EMC 9732 Lee Hettema Vol#: 407
EMC 9733 Ralph Fubar Vol#: 407
EMC 9734 Anne Shudy Vol#: 407
EMC 9735 Anne Shudy Vol#: 407
EMC 9736 Tim and Sue Hess Vol#: 407
EMC 9737 Tim and Sue Hess Vol#: 407
EMC 9738 Rev. Frank Jude Boccio, D.Ay., MSC Vol#: 407
EMC 9739 Sherrie Marchi Vol#: 407
EMC 9740 Kay Gartrell Vol#: 407
EMC 9741 Kay Gartrell Vol#: 407
EMC 9742 Adam Polakoff Vol#: 407
EMC 9743 Lori Benton Vol#: 407
EMC 9744 Lori Benton Vol#: 407
EMC 9745 Richard Kover Vol#: 407
EMC 9746 Richard Kover Vol#: 407
EMC 9747 Anthony Musci Vol#: 407
EMC 9748 Anthony Musci, M.D. Vol#: 407
EMC 9749 Cheryl Davis Vol#: 407
EMC 9750 Cheryl Davis Vol#: 407
EMC 9751 Janet Barnett Vol#: 407
EMC 9752 Janet Barnett Vol#: 407
EMC 9753 Amanda Babson Vol#: 407
EMC 9754 Robert Shurts Vol#: 407
EMC 9755 Robert Shurts Vol#: 407
EMC 9756 David Robertson Vol#: 407
EMC 9757 David Robertson Vol#: 407
EMC 9758 Angela Kline Vol#: 407
EMC 9759 Angela Kline Vol#: 407
EMC 9760 Nicolas Stecher Vol#: 407
EMC 9761 D. R. Thompson Vol#: 407
EMC 9762 Carol Ryan Vol#: 407
EMC 9763 Carol Ryan Vol#: 407
EMC 9764 Russell Engebretson Vol#: 407
EMC 9765 Russell Engebretson Vol#: 407
EMC 9766 Jennifer Schroeder Vol#: 407
EMC 9767 Rad Rademacher Vol#: 407
EMC 9768 Rad Rademacher Vol#: 407
EMC 9769 Cathy Holmes Vol#: 407
EMC 9770 Lauren Virshup Vol#: 407
EMC 9771 Lauren Virshup Vol#: 407
EMC 9772 Cathy Weiss Vol#: 407
EMC 9773 Cathy Weiss Vol#: 407
EMC 9774 Cathy Weiss Vol#: 407
EMC 9775 Renee Robinson Vol#: 407
EMC 9776 Renee Robinson Vol#: 407
EMC 9777 Jeff Klein Vol#: 407
EMC 9778 Jeff Klein Vol#: 407
EMC 9779 Jessica Freedom Vol#: 407
EMC 9780 Jessica Freedom Vol#: 407
EMC 9781 Margaret Altom Vol#: 407
EMC 9782 Margaret Altom Vol#: 407
EMC 9783 Jeanine Butler Vol#: 407
EMC 9784 Jeanine Butler Vol#: 407
EMC 9785 Ann Simun Vol#: 407
EMC 9786 Nancy O'Harrow Vol#: 407
EMC 9787 Lorrie DeJarnett Vol#: 407
EMC 9788 Bruce McNaughton Vol#: 407
EMC 9789 Bruce McNaughton Vol#: 407
EMC 9790 James Moore Vol#: 407
EMC 9791 James Moore Vol#: 407
EMC 9792 Andrea Pearson Vol#: 407
EMC 9793 Andrea Pearson Vol#: 407
EMC 9794 Karen Wexler Vol#: 407
EMC 9795 Michael Short Vol#: 407
EMC 9796 Michael Short Vol#: 407
EMC 9797 Patti Breitman Vol#: 407
EMC 9798 Patti Breitman Vol#: 407
EMC 9799 LeAnn Meyer Vol#: 407
EMC 9800 Sean C. Massey Vol#: 407
00N-1396 Bioengineered Foods Consumed By Humans or Animals
EMC 9601 Theresa Allan Vol#: 263
EMC 9602 Theresa Allan Vol#: 263
EMC 9603 Valerie V. Mehring Vol#:
EMC 9604 Nancy Viens Vol#: 263
EMC 9605 Nancy Viens Vol#: 263
EMC 9606 Sharon Andrew Vol#: 263
EMC 9607 Suzanne Slezak Vol#: 263
EMC 9608 Suzanne Slezak Vol#: 263
EMC 9609 David Jarrett Vol#: 263
EMC 9610 Nicole Levinson Vol#: 263
EMC 9611 Nicole Levinson Vol#: 263
EMC 9612 Joan Yakimik Vol#: 263
EMC 9613 Rita Klein Vol#: 263
EMC 9614 Mindy Barker Vol#: 263
EMC 9615 Mac Fry Vol#: 263
EMC 9616 Rebekah Barr Vol#: 263
EMC 9617 Nicholas Edman Vol#: 263
EMC 9618 Nicholas Edman Vol#: 263
EMC 9619 Debra Schneider Vol#: 263
EMC 9620 Kelly Winterton Vol#: 263
EMC 9621 Carol A. Crawford Vol#: 263
EMC 9622 Valerie Graham Vol#: 263
EMC 9623 Thomas B. Hatcher Vol#: 263
EMC 9624 Thomas B. Hatcher Vol#: 263
EMC 9625 Kryn Burton Vol#: 263
EMC 9626 Sonia Bermudez Vol#: 263
EMC 9627 Sonia Bermudez Vol#: 263
EMC 9628 Dawn Stutzman Vol#: 263
EMC 9629 Patricia McQuerry Vol#: 263
EMC 9630 Candice Roeder Vol#: 263
EMC 9631 Jan Jasik Vol#: 263
EMC 9632 no signature Vol#: 263
EMC 9633 Eric Olson Vol#: 263
EMC 9634 Eric Olson Vol#: 263
EMC 9635 Dr. Alan Hunter Vol#: 263
EMC 9636 Leslie Partin Vol#: 263
EMC 9637 Arthur Rochester Vol#: 263
EMC 9638 Barbara Janeway Vol#: 263
EMC 9639 Richard Morris Vol#: 263
EMC 9640 Catherine Smith Vol#: 263
EMC 9641 Marina Marelic Vol#: 263
EMC 9642 Amy Luper Vol#: 263
EMC 9643 John Minton Vol#: 263
EMC 9644 number not used Vol#: 263
EMC 9645 Ian Krieger Vol#: 263
EMC 9646 Ian Krieger Vol#: 263
EMC 9647 Don Rake Vol#: 263
EMC 9648 Don Rake Vol#: 263
EMC 9649 Marja Scheeres Vol#: 263
EMC 9650 Eugene I. Shapiro Vol#: 263
EMC 9651 Paul Nicholson Vol#: 263
EMC 9652 Paul Nicholson Vol#: 263
EMC 9653 George Zipfel Vol#: 263
EMC 9654 George Zipfel Vol#:
EMC 9655 Ynez Crawford-Taylor Vol#: 263
EMC 9656 Tuyet Nguyen Vol#: 263
EMC 9657 Eva Swidler Vol#: 263
EMC 9658 Eva Swidler Vol#: 263
EMC 9659 Allen Zerkin Vol#: 263
EMC 9660 Beca Hull-Foster Vol#: 263
EMC 9661 Beca Hull-Foster Vol#: 263
EMC 9662 A. Saivanson Vol#: 263
EMC 9663 Phillip Fujiyoshi Vol#: 263
EMC 9664 Phillip Fujiyoshi Vol#: 263
EMC 9665 Dorie Byers Vol#: 263
EMC 9666 K. Buhrmaster Vol#: 263
EMC 9667 Dolores Kaufman & Bill Braden Vol#: 263
EMC 9668 number not used Vol#: 263
EMC 9669 Tom Bassler Vol#: 263
EMC 9670 Carrie Browder Gragg Vol#: 263
EMC 9671 Christos Talanoz Vol#: 263
EMC 9672 Mindy Myer Vol#: 263
EMC 9673 Chris Darling Vol#: 263
EMC 9674 Chris Darling Vol#: 263
EMC 9675 Kathryn Lyon Vol#: 263
EMC 9676 Barbara J. Fuller Vol#: 263
EMC 9677 Barbara J. Fuller Vol#: 263
EMC 9678 Carie Zierer Vol#: 263
EMC 9679 Helen Sanders Vol#: 263
EMC 9680 Helen Sanders Vol#: 263
EMC 9681 Greg Smith Vol#: 263
EMC 9682 Linda Kaiser Vol#: 263
EMC 9683 Jean Gahan Vol#: 263
EMC 9684 Katrina Edenfeld Vol#: 263
EMC 9685 Tom Frazier Vol#: 263
EMC 9686 Neal Melton Vol#: 263
EMC 9687 number not used Vol#: 263
EMC 9688 Susan Cox Vol#: 263
EMC 9689 Gie Swinnen Vol#: 263
EMC 9690 Grian MacGregor Vol#: 263
EMC 9691 Sage Cole Vol#: 263
EMC 9692 Susan Davis Vol#: 263
EMC 9693 Susan Davis Vol#: 263
EMC 9694 Wendy Davis, Ph.D. Vol#: 263
EMC 9695 S. Sridhar Vol#: 263
EMC 9696 Jo Kirkpatrick Vol#: 263
EMC 9697 Jo Kirkpatrick Vol#: 263
EMC 9698 number not used Vol#: 263
EMC 9699 Joe Smith Vol#: 263
EMC 9700 Laura Maciuika Vol#: 263
EMC 9701 Laura Maciuika Vol#: 263
EMC 9702 Kathleen Michaud Vol#: 263
EMC 9703 Kathleen Michaud Vol#: 263
EMC 9704 Lester Kau Vol#: 263
EMC 9705 David Kratz Mathies Vol#: 263
EMC 9706 Jacqueline Nunez de Villavicencio Vol#: 263
EMC 9707 Catherine Feord Vol#: 263
EMC 9708 Laura J. Lewis Barr Vol#: 263
EMC 9709 Erin Wilson Vol#: 263
EMC 9710 Stephanie Lawner Vol#: 263
EMC 9711 Morey Fugate Vol#: 263
EMC 9712 Fred Pierre Vol#: 263
EMC 9713 Marietta Ainsworth Vol#: 263
EMC 9714 Marietta Ainsworth Vol#: 263
EMC 9715 David Kuebrich Vol#: 263
EMC 9716 David Kuebrich Vol#: 263
EMC 9717 Garret Whitney Vol#: 263
EMC 9718 Michael G. Sims Vol#: 263
EMC 9719 Martina Janssen Vol#: 263
EMC 9720 Steven Coon Vol#: 263
EMC 9721 Jan Kennedy Vol#: 263
EMC 9722 Cathryn Baillie Vol#: 263
EMC 9723 number not used Vol#: 263
EMC 9724 Tom Davis Vol#: 263
EMC 9725 Tom Davis Vol#: 263
EMC 9726 Peggy B. Dugas Vol#: 263
EMC 9727 Jack & Judy Speer Vol#: 263
EMC 9728 Melva Johnson Vol#: 263
EMC 9729 Mark Kapner Vol#: 263
EMC 9730 Mark Kapner Vol#: 263
EMC 9731 Barbara Szymanski Vol#: 263
EMC 9732 Barbara Szymanski Vol#: 263
EMC 9733 number not used Vol#: 263
EMC 9734 number not used Vol#: 263
EMC 9735 number not used Vol#: 263
EMC 9736 number not used Vol#: 263
EMC 9737 Scott Rice Vol#: 263
EMC 9738 Scott Rice Vol#: 263
EMC 9739 Nyasa Sala Kingslow Vol#: 263
EMC 9740 Nyasa Sala Kingslow Vol#: 263
EMC 9741 Andy Phoenix Vol#: 263
EMC 9742 Kate McCool Vol#: 263
EMC 9743 Kate McCool Vol#: 263
EMC 9744 Michael Diamond Vol#: 263
EMC 9745 Valerie Graham Vol#: 263
EMC 9746 Bonnie Kogod Vol#: 263
EMC 9747 Kathleen Barber Vol#: 263
EMC 9748 David M. Orens Vol#: 263
EMC 9749 Peter Burkard Vol#: 263
EMC 9750 Peter Burkard Vol#: 263
EMC 9751 Brenda Leahy Vol#: 263
EMC 9752 Carol Agle Vol#: 263
EMC 9753 Carol Agle Vol#: 263
EMC 9754 Paul Previte Vol#: 263
EMC 9755 Theresa Senn Vol#: 263
EMC 9756 Sr. Janet Lewis Vol#: 263
EMC 9757 Lawrence Peryer Vol#: 263
EMC 9758 Lawrence Peryer Vol#: 263
EMC 9759 Muzza Eaton Vol#: 263
EMC 9760 Muzza Eaton Vol#: 263
EMC 9761 no signature Vol#: 263
EMC 9762 Janah Boccio Vol#: 263
EMC 9763 Kelly Hanion Vol#: 263
EMC 9764 Rachel K. Jones Vol#: 263
EMC 9765 Rachel K. jones Vol#: 263
EMC 9766 Kara MacKeigan Vol#: 263
EMC 9767 Kara MacKeigan Vol#: 263
EMC 9768 Tammy Gersh Vol#: 263
EMC 9769 Carol Hanulcik Vol#: 263
00N-1567 Registration of Producers of Drugs & Listing of Drugs
NAL 1 Vol#: 1
SS 1 SUPPORTING STATEMENT Vol#: 1
00N-1666 Abbreviated New Drug Application Regulations; Patent & Exclu
NAL 1 Vol#: 1
SS 1 SUPPORTING STATEMENT Vol#: 1
00P-1322 Food Labeling and Allergen Contamination Control
APE 1 Food Allergy & Anaphylaxis Network Vol#: 13
APE 2 McDonald's Corporation Vol#: 13
APE 3 National Soft Drink Assoc Vol#: 13
APE 6 National Fisheries Institute Vol#: 13
APE 7 Food Allergy & Anaphylaxis Network Vol#: 13
APE 8 Nat'l Nutritional Foods Assoc Vol#: 13
APE 9 Nat'l Chapman Associates Inc Vol#: 13
APE 10 Food Allergy Research & Resource Program Vol#: 13
APE 11 Goodmark/Conagra Vol#: 13
APE 13 NSF International Vol#: 13
APE 14 International Dairy Foods Assoc Vol#: 13
APE 16 Egg Nutrition Center Vol#: 13
APE 17 Leiner Health Products Inc Vol#: 13
APE 18 Danisco Cultor Vol#: 13
BKG 1 Background material Vol#: 13
C 186 Joni Steinhaus Vol#: 13
C 187 Suzanne Kendall Vol#: 13
C 188 Mary Allen Sawtelle Vol#: 13
C 189 Clare Flocco Vol#: 13
C 190 Cheryl Anderson Vol#: 13
C 191 Carolyn Hoy Vol#: 13
C 192 Food Allergen Contamination Control Vol#: 13
NM 1 Vol#: 13
01D-0025 Guidance for Industry - Yellow Corn & Dry-Milled
C 4 Marge Folino, K Folino Vol#: 1
01D-0281 Proposed Globally Harmonized Alternative for PMA Procedures
GDL 1 Guildline Vol#: 1
NAD 1 Vol#: 1
01F-0293 safe use of ethoxyquin Phosphate in animal feeds
NFL 1 Novus Interinational, Inc. Vol#: 1
01N-0006 New Animal Drug Application, Form FDA 356 V, 21 CFR PART 514
NAL 1 Vol#: 1
SS 1 Supporting Statement Vol#: 1
01N-0051 Pilot program for Medical Devices and Blood Products
NAL 1 Supporting Statement Vol#: 1
SS 1 Supporting Statement Vol#: 1
01N-0063 Medical Devices; CGMP Quality System Regulation
NAL 1 Vol#: 1
SS 1 SUPPORTING STATEMENT Vol#: 1
01N-0073 Exemption From Premarket Notification Requirements; Class 1
NFR 1 Vol#: 1
01N-0175 Survey of Single-Use Medical Device Reuse & Reprocessing
N 2 Vol#: 1
01N-0176 GLP Regulations for Nonclinical Laboratory Studies
N 2 Vol#: 1
01N-0197 Treatment of Ankylosing Spondylitis and Related Disorders
C 3 Spondylitis Association of America Vol#: 1
01N-0301 Agency Information Collection; Customer/Partner Ser Surveys
N 1 Vol#: 1
01N-0308 Agency Information Collection; Financial Disclosure
N 1 Vol#: 1
01P-0061 Request to file an ANDA for Ifosfamide for Injection
LET 1 HFD-1 to Tom Stothoff Vol#: 1
01P-0320 Establish Format Standards for Ingredient Labels on Food Pro