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 : 12/12/2017
Location : Washington, D.C.
Subject : Duke-Margolis Center for Health Policy: Next Steps for Tobacco Harm Reduction
FDA Participant/Group : MITCHELL ZELLER;
Non FDA Participant/Group : Healthcare professionals, academia,industry reps, journalists, and other registrants ;

Event Date : 12/14/2017
Location : New York, NY
Subject : Fireside Chat at the Manhattan Institute: FDA and the Future of Precision Medicine
FDA Participant/Group : N/A
Non FDA Participant/Group : Healthcare professionals, academia, industry representatives,and other registered individuals;

Event Date : 12/14/2017
Location : SIlver Spring, MD
Subject : The National Organization for Rare Disorders (NORD)
FDA Participant/Group : NINA HUNTER; KATHLEEN QUINN; CARLYLE MCWILLIAMS; JANET WOODCOCK; DEBRA LEWIS;
Non FDA Participant/Group : Melanie Swick , Pamela Gavin , Paul Melmeyer, Peter Saltonstall, Steven Grossman ;

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 : Dara Corrigan, 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 : 12/11/2017
Location : College Park, MD
Subject : Hampton Creek: Cellular Agriculture
FDA Participant/Group : FELICIA ELLISON; SHARON NATANBLUT; DENNIS KEEFE; REBECCA GOLDBERG; REBECCA BUCKNER; PETER BECKERMAN; DOUGLAS BALENTINE; HOWARD LEVINE; JEREMIAH FASANO; FELICIA BILLINGSLEA; NEGA BERU;
Non FDA Participant/Group : David Bowman, Eitan Fischer, Wayne Szeto (Hampton Creek Incorporated); Stuart Pape (Polsinelli );

Event Date : 12/13/2017
Location : Cleveland, OH
Subject : Nestle: Facility and Laboratory Tour
FDA Participant/Group : MICKEY PARISH; STEVEN BARBER;
Non FDA Participant/Group : Jodi Taylor (Ohio Department of Agriculture); Greg Pritchard (Nestle);

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 : RADM Denise Hinton , Acting Chief Scientist

No Significant Event

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

Event Date : 12/12/2017 - 12/12/2017
Location : Cambridge, MA
Subject : The Next Wave in Adaptive Biomedical Innovation: Advancing Platform Trials into End-to-End Learning Health Systems
FDA Participant/Group : N/A
Non FDA Participant/Group : Jane Perlmutter (Gemini Group); Denis Lacombe (EORTC); Peter Kolchinsky (RACapital Managment); Laurice Levine (Children's Hospital); Gigi Hirsch; Mark Trusheim; John Glasspool (Massachusetts Institute of Technology ); Carole Mitnick (Harvard Medical School); John Ferguson (Shire ); Hans-Georg Eichler (European Medicines Agency); Brian Alexander (Dana-Farber Cancer Institute); Marina Kozak (Biomedical Advanced Research and Development Authority ); Luc Truyen (Innovative Medicines Initiative ); Susan Schaeffer (BioCentury Incorporated); Laura Esserman (University of California San Francisco); Eric Rubin (Merck & Company Incorporated); Keith Flaherty (Massachusetts General hospital); Ed Pezalla (Former Aetna); Yann LeCam (Experts on Rare Diseases ); Peter Kolchinsky (RA Capital Managment); Naomi Aronson (Blue Cross Blue Shield Association); Anna Barker (National Biomarker Development Alliance ); Michael Cusamano (Massachusetts Institute of Technology Sloan);

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 : 12/13/2017 - 12/13/2017
Location : Silver Spring, MD
Subject : Hearing Devices
FDA Participant/Group : ERIC MANN; KESIA ALEXANDER; BAKUL PATEL; MALVINA EYDELMAN; SRINIVAS NANDKUMAR;
Non FDA Participant/Group : Nancy Stade (Sidley Austin LLP); Jon Kindred and Achin Bhowmik (Starkey Hearing Technologies);

Event Date : 12/14/2017 - 12/14/2017
Location : Silver Spring, MD
Subject : Digital Health
FDA Participant/Group : BERNARD VASSEUR; ANEESH DEORAS; MATTHEW HILLEBRENNER; BAKUL PATEL; BRAM ZUCKERMAN; LINDA RICCI; SHAWN FORREST; DEBORAH CASTILLO; SIMON CHOI; MOHUA CHOUDHURY; MARISA CRUZ;
Non FDA Participant/Group : Mike Mussallem, Katie Szyman, Joanna Develter and Mark Konno (Edwards Lifesciences LLC);

Event Date : 12/15/2017 - 12/15/2017
Location : Silver Spring, MD
Subject : Cybersecurity and Quality Management System
FDA Participant/Group : SEAN BRAYBOY; ANDREW DURFOR; SEAN BOYD; LAUREL BURK; JOSEPH SHAWKY; SAPHIA WAHEED; KATELYN BITTLEMAN; ERIN KEITH; SHUMAYA ALI; VALERIE FLOURNOY; DARYLL DYKES; WILLIAM MAISEL;
Non FDA Participant/Group : Diana Upton and Robert Kerwin (International Association of Medical Equipment Remarketers and Servicers); Dave Francoeur (Sodexo); Jeff Fox (Oxford Instruments Healthcare);

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

No Significant Event

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

No Significant Event

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

Event Date : 12/11/2017 - 12/11/2017
Location : Teleconference
Subject : FDA and the European Medicines Agency: Veterinary Issues of Mutual Interest
FDA Participant/Group : LAURA HUFFMAN; HELEN SACCONE; SANDRA KWEDER; ERIC NELSON; JONATHAN BRAY; BRANDI ROBINSON; MATTHEW SCHERER; JULIE BAILEY; MICHAEL OEHLSEN; NIRAJ MEHTA; MAI HUYNH;
Non FDA Participant/Group : Agnes Saint-Raymond, Ariane Vander-Stappen, Brendan Cuddy, Esther Martinez, Gregory Verdier, Guillaume Renaud, Sabine Jaubenreisser (European Medicines Agency);

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