Public Calendar: October 4-10, 2020
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: Stephen M. Hahn, M.D., Commissioner of Food and Drugs
Event Date: 10/05/2020
Location: Teleconference
Subject: COVID-19 Vaccine Candidate
FDA Participant/Group: KEAGAN LENIHAN;
Non FDA Participant/Group: Albert Bourla, Yolanda Lyle (Pfizer);
Event Date: 10/05/2020
Location: Virtual
Subject: AdvaMed MedTech Conference; Fireside Chat: MedTech's Role in Addressing Healthcare Disparities
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, government, media, and other registered guests
Event Date: 10/06/2020
Location: Teleconference
Subject: COVID-19 Therapy Candidate
FDA Participant/Group: KEAGAN LENIHAN;
Non FDA Participant/Group: George Yancopoulos, Leonard Schleifer (Regeneron);
Event Date: 10/06/2020
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Keynote Address
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, government, academia, media, and other registered guests
Event Date: 10/07/2020
Location: Virtual
Subject: Trust for America's Health Vaccine Policy Coalition Meeting
FDA Participant/Group: DAYLE CRISTINZIO; BETH FRITSCH; PETER MARKS;
Non FDA Participant/Group: Industry, government, and other invited guests
Event Date: 10/08/2020
Location: Virtual
Subject: National Organization for Rare Disorders Rare Diseases and Orphan Products Breakthrough Summit; Keynote Address
FDA Participant/Group: HEATHER STONE; JANET MAYNARD; LARISSA LAPTEVA; PATRIZIA CAVAZZONI; HYLTON JOFFE; VISHAL BHATNAGAR; DONNA ROSCOE; MARTIN HO;
Non FDA Participant/Group: Industry, media, government, academia, and other invited guests
Event Date: 10/08/2020
Location: Virtual
Subject: Center for Infectious Disease Research and Policy Webinar; The Review Process for Vaccines to Prevent COVID-19: A Discussion
FDA Participant/Group: COLIN ROM; STEPHANIE CACCOMO;
Non FDA Participant/Group: Industry, media, government, and other registered guests
Official Name: Amy Abernethy, M.D., Ph.D, Principal Deputy Commissioner
Event Date: 10/06/2020
Location: Virtual
Subject: Healthcare Brainstorm 2020; Panel Discussion: State of COVID-19 in America
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, patient groups, and other stakeholders
Event Date: 10/06/2020
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) Conference; Fireside Chat: FDA's Digital and Technology Initatives
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry and other stakeholders
Event Date: 10/08/2020
Location: Virtual
Subject: Surescripts Network Alliance Advisory Council: Fireside Chat
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry and other invited guests
Official Name: Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs
Event Date: 10/08/2020
Location: Teleconference
Subject: Indian Country COVID-19 Update
FDA Participant/Group: MICHELLE ADAMS; NICHOLAS ALEXANDER;
Non FDA Participant/Group: Representatives from Indian Health Services, Department of Health and Human Services, U.S. Department of Agriculture, National Institute of Health, Department of Homeland Security, Center for Disease Control, and various educational institutions
Event Date: 10/08/2020
Location: Webinar
Subject: Cancer Diagnostic Devices (CD2) Interagency Task Force; 2020 Cancer Diagnostics Innovation Workshop: Focus on Near-Patient Use
FDA Participant/Group: N/A
Non FDA Participant/Group: Christopher Hartshorn, Douglas Lowy, Norman Sharpless (National Cancer Institute (NCI));
Official Name: Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs
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: 10/05/2020
Location: Virtual
Subject: FDA and Mexico Statement of Intent for a Partnership on Food Safety
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several senior officials and staff from Mexico’s National Agro-Alimentary Health, Safety and Quality Service and The Federal Commission for Protection Against Health Risks
Event Date: 10/06/2020
Location: Virtual
Subject: USDA Public Meeting on Consumer Outreach and Education
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members from across the food industry, government, and academia
Event Date: 10/07/2020
Location: Virtual
Subject: Listeria Monocytogenes Issues of Mutual Interest
FDA Participant/Group: CAITLIN BOON; LESLIE KUX; STEVEN MUSSER; LARRY MORRIS;
Non FDA Participant/Group: Several representatives from the American Frozen Food Institute
Event Date: 10/08/2020
Location: Virtual
Subject: Safe Food Coalition Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several representatives from consumer organizations, food producer trade unions, and foodborne illness victim organizations
No Significant Event
Official Name: Mark Abdoo, Associate Commissioner for Global Policy and Strategy
Event Date: 10/06/2020
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Panel Disucssion: The Global Economy of FDA-Regulated Products Under Stress
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, government, academia, media, and other registered guests
Event Date: 10/07/2020
Location: Virtual
Subject: Siemens and the General Administration of Customs China (GACC)
FDA Participant/Group: JOSEPH RIERAS, RAVI BHARWANI
Non FDA Participant/Group: John Reilly, Kathryn Derwin, Mark Shea (Siemens Corp.);
Event Date: 10/08/2020
Location: Virtual
Subject: U.S. - European Union Mutual Recognition Agreement 6th Joint Sectoral Meeting: Medical Product Quality, Safety, and Innovation
FDA Participant/Group: JADE PHAM, JOSEPH RIERAS, SUSAN LASKA, STEPHEN SOLOMON, THERESA MULLIN
Non FDA Participant/Group: Agnès Saint Raymond, Anabela Marcal, Esther Martinez, Evdokia Korakianiti, Jane Moseley, Luc Van Santvliet (European Medicines Agency (EMA)); Agnes Mathieu Mendes, Dominique De Backer, Eva Zamora Escribano, Luben Goranov, Olivier Gross, Sylvain Giraud (European Commission (EC));
Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs
No Significant Event
Official Name: Heidi Rebello, Acting Associate Commissioner for External Affairs
No Significant Event
Official Name: RADM Denise Hinton, Chief Scientist
No Significant Event
Official Name: Patrizia Cavazzoni, M.D., Acting 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
Event Date: 10/05/2020
Location: Virtual
Subject: American Association of Blood Banks (AABB) Annual Meeting; COVID-19 Convalescent Plasma: The Regulatory Landscape
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Industry, government, and other invited guests
Event Date: 10/05/2020
Location: Virtual
Subject: General discussion of science at FDA using bespoke therapies as an example
FDA Participant/Group: N/A
Non FDA Participant/Group: Participants in the McCann Health Festival of Science
Event Date: 10/06/2020
Location: Virtual
Subject: Johns Hopkins University and University of Washington COVID-19 Symposium: Regulatory Integrity and the Assessment of Vaccine Safety and Efficacy
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, government, and other invited guests
Event Date: 10/06/2020
Location: Virtual
Subject: University of Colorado (Boulder) Program for Writing and Rhetoric: A Vaccine for COVID-19? A meeting with Dr. Peter Marks of the FDA
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia and the general public
Event Date: 10/07/2020
Location: Virtual
Subject: FDA Review Process for COVID-19 Vaccine Candidates
FDA Participant/Group: N/A
Non FDA Participant/Group: Representatives from the American Medical Association
Event Date: 10/09/2020
Location: Virtual
Subject: National Organization for Rare Disorders Rare Diseases and Orphan Products Breakthrough Summit: An Update from FDA Centers
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, media, government, academia, and other invited guests
Official Name: Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health
Event Date: 10/06/2020
Location: Virtual
Subject: MedTech Annual Conference: CDRH Town Hall
FDA Participant/Group: DANIEL CANOS; ARIEL SEELEY; TIMOTHY STENZEL; MICHELLE TARVER; DOUGLAS KELLY; BINITA ASHAR; HEATHER AGLER; WILLIAM MAISEL;
Non FDA Participant/Group: Janet Trunzo (AdvaMed);
Event Date: 10/07/2020
Location: Virtual
Subject: Food and Drug Law Institue (FDLI): Center for Devices and Radiological Health Session
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, government, academia, media, and other registered guest
Official Name: Susan T. Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition
Event Date: 10/06/2020
Location: Virtual
Subject: Food and Drug Law Institute (FDLI); Center Director Breakout: Center for Food Safety and Applied Nutrition (CFSAN) Top Issues, Priorities, and Goals
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, government, academia, media, and other registered guest
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: 10/05/2020
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: JEANETTE MURPHY; WILLIAM FLYNN; TIMOTHY SCHELL; ASHLEY STEEL; CHRIS WHITEHOUSE; CINDY BURNSTEEL; CHARLI LONG; CLAUDINE KABERA; MATTHEW LUCIA; ANTONIA MONIQUE SENNETT; PATRICK MCDERMOTT; SUSAN BRIGHT-PONTE; REGINA TAN;
Non FDA Participant/Group: Representatives from American Feed Industry Association, National Pork Producers Council, Pet Food Industry, National Milk Producers Federation, National Chicken Council, American Veterinary Association, American Association of Bovine Practitioners, American Association of Swine Veterinarians, National Cattleman's Beef Association, National Turkey Federation, National Pork Board, North American Renderers Association, North American Meat Industry, Food Directions LLC
Event Date: 10/08/2020
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: PATRICK MCDERMOTT; CINDY BURNSTEEL; ANTONIA MONIQUE SENNETT; ASHLEY STEEL; SIOBHAN DELANCEY; NEAL BATALLER; SHANNON RUTHERFORD; TIMOTHY SCHELL; MATTHEW LUCIA; ANNE NORRIS; NADINE STEINBERG; WILLIAM FLYNN; SUSAN BRIGHT-PONTE;
Non FDA Participant/Group: Reprenstatives of The PEW Trusts
Official Name: William Slikker, Jr., Ph.D., Director, National Center for Toxicological Research
No Significant Event
Official Name: Stacy Cline Amin, Chief Counsel
Event Date: 10/06/2020
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) Conference; Keynote Speaker: Activities and Priorities of the Office of the Chief Counsel in 2020 and 2021
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, government, academia, media, and other registered guests