Public Calendar: June 23-29, 2019
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: Norman E. Sharpless, M.D. (Acting), Commissioner of Food and Drugs
No Significant Event
Official Name: Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner
Event Date: 06/26/2019
Location: Washington, DC
Subject: Regulation in the Innovation Age
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, academia, and members of the health care services field
Event Date: 06/27/2019
Location: Washington, DC
Subject: National Institute for Innovation in Manufacturing Biopharmaceuticals: Keynote Speaker
FDA Participant/Group: JANET WOODCOCK; PETER MARKS;
Non FDA Participant/Group: N/A
Official Name: Anna Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis
No Significant Event
Official Name: Lowell J. Schiller, Principal Associate Commissioner for Policy
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: Frank Yiannas, Deputy Commissioner for Food Policy and Response
Event Date: 06/25/2019
Location: Atlanta, GA
Subject: Association of Food and Drug Officials (AFDO) Educational Conference: U.S. Food and Drug Administration Update on Food Policy and Response: Food Traceability
FDA Participant/Group: N/A
Non FDA Participant/Group: Participants in the Association of Food and Drug Officials (AFDO) Educational Conference
Event Date: 06/27/2019
Location: Salinas, CA
Subject: Speech at the 2019 Forbes AgTech Summit: Food Traceability
FDA Participant/Group: JEFFREY FARRAR;
Non FDA Participant/Group: Participants from the 2019 Forbes AgTech Summit
Event Date: 06/28/2019
Location: Sacramento, CA
Subject: Meeting with the California Secretary of Agriculture: Food Safety and Produce
FDA Participant/Group: JAMES GORNY; JEFFREY FARRAR;
Non FDA Participant/Group: Jenny Lester Moffitt, Karen Ross, Natalie Krout-Greenberg (California Department of Food and Agriculture);
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
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: 06/27/2019
Location: Washington, DC
Subject: The National Institute for Innovation in Manufacturing Biopharmaceuticals: 2019 National Meeting: Opening Remarks
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A
Event Date: 06/28/2019
Location: Washington, DC
Subject: Patient-Centered Outcomes Research Institute: Advisory Panel on Patient Engagement
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: 06/23/2019
Location: San Diego, CA
Subject: International Coalition of Medicines Regulatory Authorities Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A
Event Date: 06/25/2019
Location: Los Angeles, CA
Subject: International Society for Stem Cell Research Pre-Meeting: FDA's Efforts to Facilitate Clinical Trials of Stem Cell Products
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A
Event Date: 06/26/2019
Location: San Diego, CA
Subject: Drug Information Association 2019 Global Meeting: The Regulation of Gene Therapies and Global Convergence of the Regulation of Advanced Therapy Medicinal Products
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A
Event Date: 06/26/2019
Location: San Diego, CA
Subject: Drug Information Association 2019 Global Meeting: The Evolving Gene Therapy Regulatory Framework: A Brave New World
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A
Event Date: 06/27/2019
Location: Washington, DC
Subject: National Institute for Innovation in Manufacturing Biopharmaceuticals 2019 National Meeting: Opening Remarks on the Challenges of Manufacturing for Gene Therapies
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: 06/25/2019
Location: Silver Spring, MD
Subject: PneumoLiner Device
FDA Participant/Group: JACQUELINE CUNKELMAN; ANN FERRITER; SHARON ANDREWS; KELLY COLDEN; VERONICA PRICE; ARON YUSTEIN; WILLIAM MAISEL; ANGIE LEE; BENJAMIN FISHER; CHARLES VIVIANO; JOYCE WHANG;
Non FDA Participant/Group: Alexis James, Jeri Hitchings, Manisha Shah-Bugaj (Olympus Corporation); Edward Hyland, Frank Bonadio, Shane MacNally (Advanced Surgical Concepts);
Event Date: 06/26/2019
Location: Silver Spring, MD
Subject: Emerging Postmarket Medical Device Signals
FDA Participant/Group: ARON YUSTEIN; WILLIAM MAISEL; MEGAN GATSKI; ALICIA WITTERS; LYNNE RICE;
Non FDA Participant/Group: Janet Trunzo, Zach Rothstein (Advanced Medical Technology Association);
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
Event Date: 06/26/2019
Location: Silver Spring, MD
Subject: Society for Research on Nicotine & Tobacco (SRNT) Meeting to Coordinate CTP's Participation in the 2020 Annual Conference
FDA Participant/Group: MITCHELL ZELLER; MICHELE MITAL;
Non FDA Participant/Group: Several representatives from the Society for Research on Nicotine & Tobacco (SRNT)
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: 06/23/2019
Location: San Diego, CA
Subject: Teratology Society Annual Meeting 2019: Multidisciplinary Research Needs
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, academia, and other invited guests
Official Name: Stacy Cline Amin, Chief Counsel
Event Date: 06/26/2019
Location: Silver Spring, MD
Subject: FDA Reauthorization Act (FDARA) Implementation Issue
FDA Participant/Group: CESAR PEREZ; DAVID MEDNICK; LOUISE HOWE; SARA BEARDSLEY; SEAN BOYD; ELLEN FLANNERY; RENEE BEAVER;
Non FDA Participant/Group: Janet Trunzo, Zach Rothstein (Advanced Medical Technology Association); Nathan Brown (Akin Gump Strauss Hauer and Feld LLP);