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: Janet Woodcock, M.D., Acting Commissioner

Event Date: 08/04/2021
Location: Virtual
Subject: Trial Updates and Protocols
FDA Participant/Group: PETER STEIN;
Non FDA Participant/Group: Parties involved in Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)

Official Name: Andi Lipstein Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs

Event Date: 08/06/2021
Location: Virtual
Subject: Listening Session Regarding Regulation of Diagnostic Tests
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives from the Diagnostic Test Working Group

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: Erica Jefferson, Associate Commissioner for External Affairs

No Significant Event

Official Name: RADM Denise Hinton, Chief Scientist

No Significant Event

Official Name: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research

Event Date: 08/03/2021
Location: Virtual
Subject: Prescription Drug User Fee Act (PDUFA) VI Meeting
FDA Participant/Group: ANDREW KISH; JAMES TYLER; ERIC STONE; JOSHUA BARTON;
Non FDA Participant/Group: Representatives from industry

Event Date: 08/04/2021
Location: Virtual
Subject: Understanding Payer Evidentiary Needs for Alzheimers
FDA Participant/Group: MICHELLE CAMPBELL;
Non FDA Participant/Group: Marianne Hamilton, Mark McClellan, Morgan Romine, Nitzine Arad (Duke-Margolis);

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

Event Date: 08/03/2021
Location: Virtual
Subject: COVID-19 Vaccine Education and Equity Project; COVID-19 Vaccine Considerations for Back-to-School Season
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the COVID-19 Vaccine Considerations for Back-to-School Season

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

Event Date: 08/05/2021
Location: Virtual
Subject: Medical Device Information Analysis and Sharing (MDIAS) Public-Private Partnership (PPP) Meeting
FDA Participant/Group: ERIN KEITH; FRANCISCO VICENTY; OWEN FARIS; WILLIAM MAISEL;
Non FDA Participant/Group: Eva Katcher, Pam Douglas, Heather Hawley, Ed Walsh, Angie Hinzey (MITRE)

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: 08/03/2021
Location: Virtual
Subject: Toxicology Forum Virtual Session; Speaker: Regulatory Science within US FDA
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders

Event Date: 08/05/2021
Location: Virtual
Subject: Arkansas Research Alliance Board Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Arkansas Research Alliance board members

Official Name: Mark Raza, J.D., Acting Chief Counsel

No Significant Event