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: 12/10/2018
Location: Washington, DC
Subject: Alexandria Summit: Healthcare Policy Forum
FDA Participant/Group: CARLYLE MCWILLIAMS;
Non FDA Participant/Group: Industry, academia, government, and other invited guests

Event Date: 12/11/2018
Location: Washington, DC
Subject: Food and Drug Administration/Centers for Medicare and Medicaid Services Summit: Marshal in the Next Era of U.S. Regulatory Policy as It Intersects with Breakthrough Scientific Innovation
FDA Participant/Group: KATHLEEN QUINN; JANET WOODCOCK;
Non FDA Participant/Group: Industry, government, media, and other registered guests

Event Date: 12/12/2018
Location: Washington, DC
Subject: Food and Drug Law Institute: Enforcement, Litigation and Compliance Conference: Drug, Device, Food, and Tobacco Industries
FDA Participant/Group: Several FDA officials and staff
Non FDA Participant/Group: Industry, government, media, and other registered guests

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

Event Date: 12/10/2018
Location: Silver Spring, MD
Subject: United States-European Union Mutual Recognition Agreement, 2nd Joint Sectoral Meeting
FDA Participant/Group: STEVEN SOLOMON, ELLEN MORRISON, MARY MALARKEY, THERESA MULLIN, RITA NALUBOLA, SUSAN LASKA, MICHAEL OEHLSEN, JOAN BLAIR, BRIAN HASSELBALCH
Non FDA Participant/Group: Anna Eva Ampelas, Agnes Mathieu, Dominique Debacker, Luben Goranov, Agnes Saint Raymond, Sabine Haubenreisser, Tania Teixeria, Brendan Cuddy, several members from the European Commission, several members from the European Medicines Agency

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

Official Name: Frank, Yiannas, Deputy Commissioner for Food Policy & Response

No Significant Event

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: Keagan Lenihan, Associate Commissioner for External Affairs

Event Date: 12/11/2018
Location: Washington, DC
Subject: Venture Capitalists Investment in Antibacterial Drug Development
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Several representatives from the Biotechnology Innovation Organization/Antimicrobials Working Group

Event Date: 12/11/2018
Location: Silver Spring, MD
Subject: Mylan Pharmaceutical: Drug Shortages
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Several representatives from the Mylan Pharmaceutical Company

Event Date: 12/13/2018
Location: Silver Spring, MD
Subject: Baystate Health: Drug Shortages
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Several representatives from the Baystate Health organization

Event Date: 12/13/2018
Location: Silver Spring, MD
Subject: Drug Shortages Task Force Meeting
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Betsy Ferguson, Donald Dempsey, Sara Hankins (CVS Health);

Event Date: 12/14/2018
Location: Silver Spring, MD
Subject: Drug Shortage Task Force Meeting
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Several representatives from the Greater New York Hospital Association

Official Name: RADM Denise Hinton, Chief Scientist

No Significant Event

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

Event Date: 12/13/2018
Location: Arlington, VA
Subject: Parent Project Muscular Dystrophy: Inflammation in Duchenne: Current Treatments and New Strategies
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

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

Event Date: 12/11/2018
Location: Boston, MA
Subject: Biomedical Innovation BioManufacturing Program: FDA's Efforts to Advance the Development of Advanced Therapy Medicinal Products
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

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

Event Date: 12/14/2018
Location: Silver Spring, MD
Subject: Cardiovascular Devices
FDA Participant/Group: WILLIAM MACFARLAND; WILLIAM MAISEL; MARK FELLMAN; MARCO CANNELLA; MATTHEW HILLEBRENNER; FERNANDO AGUEL; KENNETH CAVANAUGH; NICOLE IBRAHIM; JESSICA PAULSEN; BRAM ZUCKERMAN;
Non FDA Participant/Group: Chuck Brynelsen, Gary Johnson, Jim Krater, Lisa Becker, Mike Dale, Mike Pederson, Priya Jagasia (Abbott);

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

No Significant Event

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

Event Date: 12/13/2018
Location: Little Rock, Arkansas
Subject: Selection of Dr. Steven Foley as the New Arkansas Research Alliance Fellow
FDA Participant/Group: STEVEN FOLEY;
Non FDA Participant/Group: Several members from the Arkansas Research Alliance

Official Name: Stacy Cline Amin, Chief Counsel

No Significant Event

Official Name: FRANK YIANNAS, Deputy Commissioner for Food Policy and Response

No Significant Event