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: 12/07/2020
Location: Virtual
Subject: FDA-CMS Summit: Garner Efficiencies in Regulatory and Reimbursement Processes In a COVID Era
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, government, academia, media and other registered guests

Event Date: 12/07/2020
Location: Virtual
Subject: COVID-19 Vaccines, Therapeutics and the Emergency Use Authorization Process
FDA Participant/Group: NIKIJA SHUMAN; PETER MARKS; DAYLE CRISTINZIO; BETH FRITSCH;
Non FDA Participant/Group: Several members of the Federation of American Hospitals

Event Date: 12/08/2020
Location: Virtual
Subject: COVID-19 Vaccines and Emergency Use Authorization Process
FDA Participant/Group: JULIA TIERNEY; MICHELLE ADAMS; NICHOLAS ALEXANDER; LORRIE MCNEILL; PETER MARKS; KEAGAN LENIHAN;
Non FDA Participant/Group: Several staff from the New York State Health Commissioner's Office and members of the New York COVID-19 Clinical Advisory Task Force

Event Date: 12/08/2020
Location: Virtual
Subject: Reagan-Udall Foundation: Innovations in Regulatory Science Awards
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, government, academia, media, and other registered guests

Event Date: 12/08/2020
Location: Virtual
Subject: COVID-19 Vaccines and Emergency Use Authorization Process
FDA Participant/Group: LORRIE MCNEILL; BETH FRITSCH; DAYLE CRISTINZIO; KEAGAN LENIHAN; PETER MARKS;
Non FDA Participant/Group: Several hospital stakeholders

Event Date: 12/08/2020
Location: Virtual
Subject: COVID-19 Vaccines and Emergency Use Authorization Process
FDA Participant/Group: BETH FRITSCH; LORRIE MCNEILL; DAYLE CRISTINZIO; KEAGAN LENIHAN; PETER MARKS;
Non FDA Participant/Group: Several pharmacy stakeholders

Event Date: 12/09/2020
Location: Virtual
Subject: COVID-19 Vaccines and Emergency Use Authorization Process
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Governors, state senior health officials, and state senior policy staff

Event Date: 12/09/2020
Location: Virtual
Subject: COVID-19 Vaccines and Emergency Use Authorization Process
FDA Participant/Group: DAYLE CRISTINZIO; BETH FRITSCH; JULIA TIERNEY; PETER MARKS;
Non FDA Participant/Group: Several members of the Alliance for a Stronger FDA

Event Date: 12/09/2020
Location: Virtual
Subject: COVID-19 Vaccines and Emergency Use Authorization Process
FDA Participant/Group: PETER MARKS; DAYLE CRISTINZIO; BETH FRITSCH; LORRIE MCNEILL; JULIA TIERNEY;
Non FDA Participant/Group: Several medical association stakeholders

Event Date: 12/09/2020
Location: Virtual
Subject: COVID-19 Vaccines and Emergency Use Authorization Process
FDA Participant/Group: LORRIE MCNEILL; PETER MARKS; KEAGAN LENIHAN; DAYLE CRISTINZIO; BETH FRITSCH; JULIA TIERNEY;
Non FDA Participant/Group: Several nursing association stakeholders

Event Date: 12/11/2020
Location: Virtual
Subject: COVID-19 Vaccines and Emergency Use Authorization Process
FDA Participant/Group: LORRIE MCNEILL; PETER MARKS; DAYLE CRISTINZIO; BETH FRITSCH;
Non FDA Participant/Group: Several member of the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine

Official Name: Amy Abernethy, M.D., Ph.D, Principal Deputy Commissioner

Event Date: 12/07/2020
Location: Virtual
Subject: Digital Medicine Conference: Balancing Regulation, Innovation, and Safety During the Pandemic and Beyond
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, industry, and other stakeholders

Event Date: 12/08/2020
Location: Virtual
Subject: Alexandria Summit Duke Margolis Health Care Policy Forum
FDA Participant/Group: JOSEPH FRANKLIN;
Non FDA Participant/Group: Academia, provider groups, government, and other invited stakeholders

Event Date: 12/08/2020
Location: Virtual
Subject: 2020 Innovations in Regulatory Science Awards
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Academia, patient groups, industry, and other stakeholders

Event Date: 12/09/2020
Location: Virtual
Subject: Milken Institute 2020 Future of Health Summit: COVID-19 Presses the Accelerator on Biomedical Research and Devlopment (R&D) Panel
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, patient groups, industry, and other stakeholders

Event Date: 12/09/2020
Location: Virtual
Subject: FDA-CMS Summit Panel: Realizing the Full Promise of Real World Evidence in Drug Development
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, patient groups, industry, and other stakeholders

Event Date: 12/10/2020
Location: Virtual
Subject: National Academy of Medicine (NAM) Digital Health Sector Paper Authors Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, industry, and other invited stakeholders

Event Date: 12/10/2020
Location: Virtual
Subject: National Academy of Medicine (NAM) COVID-19 Sector Impact Assessments
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, industry, and other invited stakeholders

Event Date: 12/11/2020
Location: Virtual
Subject: PCORnet Priorities Meeting: Q&A with Dr. Abernethy
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, industry, and other stakeholders

Official Name: Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs

No Significant Event

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

No Significant Event

Official Name: Mark Abdoo, Associate Commissioner for Global Policy and Strategy

No Significant Event

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: 12/07/2020
Location: Virtual
Subject: FDA-CMS Summit 2020; Fireside Chat: A Review of Current Priorities for CBER and How the Pandemic is Impacting FDA Resources, Efficiencies and Shifts in Processes
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, patient groups, industry, and other stakeholders

Event Date: 12/08/2020
Location: Virtual
Subject: Rice University's Baker Institute for Public Policy Webinar; COVID-19 Vaccines: Clinical Trials, Approval and Addressing Public Hesitancy
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, patient groups, industry, and other stakeholders

Event Date: 12/08/2020
Location: Virtual
Subject: FDA-CMS Summit 2020: Addressing Challenges and Opportunities in Cell and Gene Therapy Development
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, patient groups, industry, and other stakeholders

Event Date: 12/08/2020
Location: Virtual
Subject: White House Summit on COVID-19 Vaccine; FDA's Emergency Use Authorization (EUA) Process
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, patient groups, industry, and other stakeholders

Event Date: 12/08/2020
Location: Virtual
Subject: Reagan-Udall Foundation Innovation in Regulatory Science Awards; 2021 CBER Outlook
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, patient groups, industry, and other stakeholders

Event Date: 12/09/2020
Location: Virtual
Subject: Alliance for Stronger FDA Webinar; COVID Emergency Use Authorization (EUA) Process and Lessons Learned
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, patient groups, industry, and other stakeholders

Event Date: 12/10/2020
Location: Virtual
Subject: Vaccines and Related Biological Products Advisory Committee Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, industry, and other stakeholders

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

Event Date: 12/08/2020
Location: Virtual
Subject: Reagan-Udall Foundation Awards: Center for Devices and Radiological Health 2021 Update
FDA Participant/Group: JUDITH MCMEEKIN; PETER MARKS; MITCHELL ZELLER; STEPHEN SOLOMON; SUSAN MAYNE; PATRIZIA CAVAZZONI;
Non FDA Participant/Group: Representatives from industry, consumer groups, and other stakeholders

Event Date: 12/10/2020
Location: Virtual
Subject: Medical Device Innovation Consortium Board of Directors Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Representatives from the medical device industry, government, and patient groups

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: Stacy Cline Amin, Chief Counsel

No Significant Event