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  5. Public Calendar: February 4 - 10, 2018
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: February 4 - 10, 2018

This public calendar is issued by the Food and Drug Administration. It lists significant meetings held by designated FDA policy makers with persons outside the executive branch of the Federal Government.

Official Name : Scott Gottlieb, M.D., Commissioner of Food and Drugs

Event Date : 02/05/2018 - 02/05/2018
Location : Silver Spring, MD
Subject : FDA's New Comprehensive Plan for Tobacco and Nicotine Regulation
FDA Participant/Group : KATHLEEN QUINN; JOSEPHINE TROPEA; RICHARD TURMAN; ROBIN APPLEBERRY; MITCHELL ZELLER; LAUREN SILVIS; MICHELE MITAL; ANNA ABRAM; DAVID MEDNICK;
Non FDA Participant/Group : Andre Calantzopoulos, Moira Gilchrist (Philip Morris International);

Event Date : 02/05/2018 - 02/05/2018
Location : Silver Spring, MD
Subject : Clinical Trials and Childhood Cancer
FDA Participant/Group : PETER MARKS; LAUREN SILVIS;
Non FDA Participant/Group : Thomas Whitehead (Emily Whitehead Foundation);

Event Date : 02/06/2018 - 02/06/2018
Location : Washington, DC
Subject : American Society of Clinical Oncology the Goals and Priorities
FDA Participant/Group : LAUREN SILVIS; JANET WOODCOCK; CANDRA SMITH; ANNA FINE;
Non FDA Participant/Group : Anne Tsao, Bruce Johnson, Craig Delisdish, Monica Bertagnolli, Richard Schilsky, Suanna Bruinooge (American Society of Clinical Oncology);

Event Date : 02/06/2018 - 02/06/2018
Location : Washington, DC
Subject : Alliance for a Stronger FDA - Annual General Body Meeting: FDA Priorities
FDA Participant/Group : NINA DEVLIN; LAUREN SILVIS; CARLYLE MCWILLIAMS;
Non FDA Participant/Group : Patient groups, consumer advocates, biomedical research advocates, health professionals, media, and regulated industries

Event Date : 02/07/2018 - 02/07/2018
Location : Bethesda, MD
Subject : 10th Annual Sentinel Initiative Public Workshop: Ongoing Development of the Sentinel Initiative and Key Achievements Over the Past Year
FDA Participant/Group : N/A
Non FDA Participant/Group : Stakeholders, governement, media, health system leaders and patient advocates

Event Date : 02/07/2018 - 02/07/2018
Location : Silver Spring, MD
Subject : Essure Concerns
FDA Participant/Group : CANDRA SMITH; JOHN MARTIN; LAURA BAILIS; SHARON ANDREWS; MEGAN GATSKI; TERRI CORNELISON; LAUREN SILVIS;
Non FDA Participant/Group : Justin Parafinczuk, Marcus Susen (Koch Parafinczuk Wolf Susen); Amanda Dykeman, Amanda Rusmisell, Angela Desa Lynch, Angie Firmalino, Tess Schulman (Essure Problems Group); Madris Tomes (Device Events); Holly Ennis (Ennis & Ennis, P.A.);

Event Date : 02/07/2018 - 02/07/2018
Location : Silver Spring, MD
Subject : FDA/PhRMA BIO CEO Meeting: PDUFA VI Implementation Progress
FDA Participant/Group : WILLIAM LEWALLEN; ANNA ABRAM; ANDREW KISH; THERESA MULLIN; RACHEL SHERMAN; MELANIE KELLER; LAUREN SILVIS; JANET WOODCOCK; AMANDA EDMONDS; CHRISTOPHER JONECKIS; PATRICK FREY; JOSHUA BARTON; JAMES TYLER;
Non FDA Participant/Group : John Maraganore (Alnylam Pharmaceuticals Incorporated); Robert Bradway (Amgen Incorporated); Lucy Vereshchagina (Pharmaceutical Research and Manufacturers of America); Cartier Esham (Emerging Companies at the Biotechnology Innovation Organization ); Richard Pops (Alkermes);

Official Name : Rachel Sherman, M.D., M.P.H.,, Principal Deputy Commissioner

No Significant Event

Official Name : Anna Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis

No Significant Event

Official Name : Mark Abdoo , Acting Deputy Commissioner for Global Regulatory Operations and Policy

No Significant Event

Official Name : Jim Sigg, Deputy Commissioner for Operations

No Significant Event

Official Name : Stephen M. Ostroff, M.D., Deputy Commissioner for Foods and Veterinary Medicine

Event Date : 02/05/2018
Location : Silver Spring, MD
Subject : United States Codex Policy Committee Meeting
FDA Participant/Group : DANIEL FOLMER; SUSAN MAYNE; PAUL HONIGFORT; STEVEN SOLOMON; CAROLINE DEWAAL; CAMILLE BREWER;
Non FDA Participant/Group : Several representatives (United States Department of Agriculture-Agricultural Marketing Service ); Several representatives (United States Department of Agriculture-Animal and Plant Health Inspection Service ); Several representatives (United States Department of Agriculture-Food Safety and Inspection Service); Several representatives (United States Department of Agriculture-Office of the Secretary );

Event Date : 02/09/2018
Location : Fort Worth, TX
Subject : National Cotton Ginners' Association Board of Directors Meeting: Food Safety Modernization Act
FDA Participant/Group : N/A
Non FDA Participant/Group : Several representatives (National Cotton Council); Several representatives (National Cotton Ginners Association); Several representatives (Cotton Ginners Board of Directors);

Official Name : Melinda Plaisier, Associate Commissioner for Regulatory Affairs

No Significant Event

Official Name : Mary Lou Valdez, M.S.M., Associate Commissioner for International Programs

No Significant Event

Official Name : Jennifer Rodriguez, Acting Associate Commissioner for External Affairs

No Significant Event

Official Name : RADM Denise Hinton , Acting Chief Scientist

No Significant Event

Official Name : Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research

No Significant Event

Official Name : Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

No Significant Event

Official Name : Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health

Event Date : 02/05/2018 - 02/05/2018
Location : Silver Spring, MD
Subject : Renal Denervation Program
FDA Participant/Group : COURTNEY LIAS; RAM TIWARI; KENNETH CAVANAUGH; DONALD ST PIERRE; HIREN MISTRY; WILLIAM MAISEL; MISTI MALONE; STAYCE BECK; BRAM ZUCKERMAN;
Non FDA Participant/Group : Bonnie Handke , Fran Kaufman, Garrett Pilcher , Gerardine Finn , Hooman Hakami, James Dabbs, Luann Pendy, Manuela Negoita, Mark O'Donnell, Martin Rothman, Mike Coyle, Omar Ishrak, Rick Kuntz, Sidney Cohen (Medtronic );

Event Date : 02/07/2018 - 02/07/2018
Location : Silver Spring, MD
Subject : General Medical Device Issues
FDA Participant/Group : LAUREL BURK; SEAN BRAYBOY; KATELYN BITTLEMAN; ANDREW DURFOR; WILLIAM MAISEL; VALERIE FLOURNOY; SHUMAYA ALI;
Non FDA Participant/Group : Tim McGeath ( TriMedx); John Williams and Andrew Coats (Hall, Render, Killian, Heath & Lyman, p.c.); David Franceour (Sodexo Incorporated);

Official Name : Susan T. Mayne Ph.D., Director, Center for Food Safety and Applied Nutrition

Event Date : 02/05/2018 - 02/05/2018
Location : Washington. DC
Subject : Institute of Food Technologist (IFT): 2018 IFT Food Policy Impact
FDA Participant/Group : N/A
Non FDA Participant/Group : N/A

Official Name : Mitchell R. Zeller, J.D., Director, Center for Tobacco Products

No Significant Event

Official Name : Steven Solomon, Director, Center for Veterinary Medicine

No Significant Event

Official Name : William Slikker, Jr., Ph.D., Director, National Center for Toxicological Research

No Significant Event

Official Name : Rebecca K. Wood, J.D., Chief Counsel

No Significant Event

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