Public Calendar: September 9-15, 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: 09/11/2018
Location: Washington, DC
Subject: International Coalition of Medicines Regulatory Authorities Summit: Patients and Science at the Center of 21st Century Regulations
FDA Participant/Group: Several FDA staff members
Non FDA Participant/Group: Several representatives from the foreign medicines regulatory authorities, international organizations, and government
Event Date: 09/12/2018
Location: Silver Spring, MD
Subject: Public Hearing: The FDA Predictive Toxicology Roadmap and Its Implementation
FDA Participant/Group: Several FDA staff members
Non FDA Participant/Group: Industry, media, government, and registered guests
Event Date: 09/13/2018
Location: Washington, DC
Subject: Forum: Charting the Course for Precision Medicine
FDA Participant/Group: JOHN MARTIN; REENA PHILIP; TIMOTHY STENZEL; KATHLEEN QUINN;
Non FDA Participant/Group: Industry, government, academia, patient advocacy groups, and media
Event Date: 09/13/2018
Location: Washington, DC
Subject: Symposium: Kid's Brain Cancer - A Look Foward: Advances Toward A Cure
FDA Participant/Group: MAREN KAHN; JOHN MARTIN;
Non FDA Participant/Group: Industry, patient advocacy groups, government, media, and registered guests
Event Date: 09/14/2018
Location: Washington, DC
Subject: Symposium: Strengthening Antimicrobial Resistance
FDA Participant/Group: KEAGAN LENIHAN; KATHLEEN QUINN;
Non FDA Participant/Group: Media, government, industry, academia, and 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
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: 09/10/2018
Location: Silver Spring, MD
Subject: Romaine Lettuce Outbreak and the Investigation Process
FDA Participant/Group: LARRY MORRIS; STEPHEN OSTROFF; ORVILLE HARRIS; KEVIN GERRITY; DOUGLAS STEARN; KARI IRVIN; SAMIR ASSAR; CHARLOTTE CHRISTIN; PETER BECKERMAN; JAMES GORNY; TRACEY SANDERS; MICHAEL ROGERS;
Non FDA Participant/Group: Job Luque, Jordan Levi, Mike Thoren, Tom McDonald (Five Rivers Cattle Feeding); Don L. Zink (IEH Laboratories & Consulting Group); Sheldon Bradshaw, Smitha G. Stansbury (King & Spalding LLP); Collin Woodall, Danielle Beck (National Cattlemen’s Beef Association); Chandler Keys (Principle Keys Group LLC);
Event Date: 09/11/2018
Location: Washington DC
Subject: American Frozen Food Institute: Government Action Summit
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, media, industry, academia, and other invited guests
Event Date: 09/12/2018
Location: Hartford, CT
Subject: National Association of State Departments of Agriculture Annual Meeting
FDA Participant/Group: BARBARA CASSENS; JEFFREY FARRAR; STEPHEN OSTROFF;
Non FDA Participant/Group: Government, media, industry, academia, and other invited guests
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, Chief Scientist
No Significant Event
Official Name: Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research
Event Date: 09/12/2018
Location: Washington, DC
Subject: The Impact of the Revolutionary I-Spy 2 Trials
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A
Event Date: 09/15/2018
Location: Baltimore, MD
Subject: Clinical Trials and Regulatory Science Workshop
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: 09/12/2018
Location: Washington, DC
Subject: 2018 International Coalition of Medicines Regulatory Authorities Summit
FDA Participant/Group: JOAN BLAIR;
Non FDA Participant/Group: Several delegations from the International Coalition of Medicines Regulatory Authorities
Event Date: 09/13/2018
Location: Silver Spring, MD
Subject: American Society of Gene and Cell Therapy (ASGCT)/FDA Liaison Meeting
FDA Participant/Group: Several CBER officials and staff members
Non FDA Participant/Group: Several respresentatives from the American Society of Gene and Cell Therapy
Event Date: 09/15/2018
Location: Miami Beach, FL
Subject: Cord Blood Connect Meeting: FDA’s Efforts to Advance the Development of Regenerative Medicine Therapy 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: 09/12/2018
Location: Baltimore, MD
Subject: Patient Engagement in the National Evaluation System for Health Technology: Lessons Learned and Best Practices
FDA Participant/Group: GREGORY PAPPAS; DANICA MARINAC; LISA MILLER; NNEKA ONWUDIWE;
Non FDA Participant/Group: N/A
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
No Significant Event
Official Name: Lowell Schiller, J.D.,, Acting, Chief Counsel
No Significant Event