Update Nov Dec 2013 - (Page 4)

FDLI Update Staff Editor-in-Chief Michael Levin-Epstein, J.D., M.Ed. Editor Rachael A. Vieder, J.D. Graphic and Web Designer Natalia Gonzalez ISSN: 1075-7635 - Issue 6 (2013) General Information: Update is published six times per year by The Food and Drug Law Institute (FDLI). FDLI is a non-profit organization that provides a marketplace for discussing food and drug law issues through conferences, publications and member interaction. The scope of FDLI includes food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco. As a not-for-profit 501(c)(3) organization, FDLI does not engage in advocacy activities. Articles and any other material published in Update represent the opinions of the author(s) and should not be construed to reflect the opinions of FDLI, its staff or its members. The factual accuracy of all statements in the articles and other materials is the sole responsibility of the authors. Diversity Policy Statement: In principle, and in practice, FDLI values and seeks a diverse and inclusive membership and welcomes full participation by all people, regardless of race, gender, creed, age, sexual orientation, national origin or disability. Membership: FDLI members receive Update as a part of their membership. For information about membership, contact FDLI's Membership Department at 202-371-1420 or membdept@fdli.org. Subscription: Subscription to Update is available for $100.00 per year (6 issues). Additional copies or back issues are available at $50.00 each. Individual articles are available at $25.00 each. To order, contact Customer Service at 202-371-1420 or comments@fdli.org. Article Contributions: We invite you to share your expertise and perspective and to comment on articles or ideas covered in recent issues of Update. All manuscripts are subject to editing for style, clarity, sexist language, and length. Manuscripts and inquiries should be directed to Michael Levin-Epstein, Editor-in-Chief, FDLI, 1155 15th St., NW, Ste. 800, Washington, DC 20005, via e-mail to mdl@fdli.org, or via telephone at 202-222-0897. Send notices of change of address to FDLI six to eight weeks in advance. Please include both old and new addresses. Notices also may be sent to comments@fdli.org. Advertising in Update: Creative Director Jennifer Soucy The YGS Group FDLI 1155 15th St., NW, Ste. 800 Washington, D.C. 20005 Ph: 202-371-1420 Fax: 202-371-0649 E-mail: comments@fdli.org Website: www.fdli.org Update Editorial Advisory Board Elizabeth Barr Fawell, Chair, Hogan Lovells LLP Margaret Sova McCabe, Vice Chair University of New Hampshire School of Law Desiree Ralls-Morrison, Board Liaison Boehringer Ingelheim Barry A. Berger Temple University Mitchell A. Cheeseman, Ph.D. Steptoe & Johnson LLP Steven J. Ellcessor Frost Brown Todd LLC Hope S. Freiwald Dechert LLP Lori F. Hirsch Merck & Co., Inc. Kari K. Loeser Genentech, Inc. Alexandra Marzelli BD Srikumaran Melethil Law and Science Consulting Jessica O'Connell FDA - OC Peggy Pence Symbion Research International, Inc. If you would like to see your organization or product in Update, and reach nearly 7,000 of the industry's key decision makers, contact Rachael Vieder for advertising rates and a media kit at 202-222-0904 or rav@fdli.org Diane E. Robertson Ph.D. PWR Application to mail at periodicals postage rates is pending at Washington, DC and at additional mailing offices. Cicely N. Vaughn FDA - ORA © 2013 Food and Drug Law Institute Cara Welch Natural Products Association ECO BOX Update text and cover pages are printed on SFI-certified Anthem Matte Plus paper using soy ink. * The SFI certified sourcing label is proof FDLI is using fiber from responsible and legal sources. * The Sustainable Forestry Initiative® program integrates the perpetual growing and harvesting of trees with the protection of wildlife, plants, soils, and water. * The Sustainable Forestry Initiative® program promotes responsible forest management. Alex Stack Gilbert's LLP FDLI Officers Chair Elizabeth H. Anderson Vice Chair Philip Katz Immediate Past Chair Geoffrey M. Levitt Treasurer Patricia B. Schrader Secretary and General Counsel Jeffrey N. Gibbs President and CEO Susan C. Winckler Postmaster: Send changes of address to: ISSN: 1075-7635 Issue 6 (2013) 4 Update November/December 2013 FDLI Update 1155 15th St., NW, Ste. 800 Washington, DC 20005 www.fdli.org http://www.fdli.org http://www.sfiprogram.org http://www.fdli.org

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013