Public Calendar: September 19-25, 2021

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: 09/20/2021
Location: Virtual
Subject: Pharmacodynamic Biomarkers for Biosimilar Approval Public Workshop
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, media, and other registered guests

Event Date: 09/21/2021
Location: Virtual
Subject: Alliance for Aging Research 2021 Roundtable; Looking Ahead: A Conversation on the Future of Regulatory Science and Medical Innovation for Older Adults
FDA Participant/Group: ALEXANDER WOHL; JEFFREY SHUREN; DAYLE CRISTINZIO;
Non FDA Participant/Group: Government, industry, academia, and other invited guests

Event Date: 09/21/2021
Location: Virtual
Subject: Advancing Generic Drug Development: Translating Science to Approval
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, media, and other registered guests

Event Date: 09/22/2021
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)

Event Date: 09/23/2021
Location: Virtual
Subject: Scientific Adventures for Girls Speaker Series: The COVID Variant! Women Leaders Share Information on What the Near Future Holds
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, academia, and other registered guests

Event Date: 09/23/2021
Location: Virtual
Subject: National Academy of Medicine Consortium Members Meeting: The Learning Health System in Action
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, academia, and other invited guests

Event Date: 09/24/2021
Location: Virtual
Subject: Pfizer-BioNTech COVID-19 Boosters
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, healthcare stakeholders, and other invited guests

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

Event Date: 09/23/2021
Location: Virtual
Subject: American Society of Gene and Cell Therapy (ASGCT) Policy Summit
FDA Participant/Group: N/A
Non FDA Participant/Group: Members and participants of the ASGCT Policy Summit

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

Official Name: Frank Yiannas, Deputy Commissioner for Food Policy and Response

Event Date: 09/21/2021
Location: Virtual
Subject: 2021 National Association of State Departments of Agriculture Annual Meeting; FDA Foods Program Update
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Executives of state and territory level Departments of Agriculture

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

No Significant Event

Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs

Event Date: 09/21/2021
Location: Virtual
Subject: 8th Annual Medical Device Regulations Conference: ORA Update
FDA Participant/Group: N/A
Non FDA Participant/Group: Medical device industry and academia members

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: 09/22/2021
Location: Virtual
Subject: International Coalition of Medicines Regulatory Authorities (ICMRA) Executive Committee Teleconference
FDA Participant/Group: PETER MARKS; PATRIZIA CAVAZZONI;
Non FDA Participant/Group: International regulatory administrators

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

Event Date: 09/23/2021
Location: Virtual
Subject: Complexities of Convalescent Plasma
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the National Institutes of Health / American Red Cross 40th Annual Immunohematology and Blood Transfusion Symposium

Event Date: 09/25/2021
Location: Virtual
Subject: Vaccine Boosters and Q&A with CDC's Vaccine Task Force: FDA Update
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the Centers for Disease Control and Prevention / Infectious Diseases Society of America COVID-19 Clinician Call

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

Event Date: 09/21/2021
Location: Virtual
Subject: 8th Annual Medical Device Regulations Conference: CDRH Update
FDA Participant/Group: BAKUL PATEL; DANIEL SOLIS; KATHLEEN SINNINGER; COLIN TACK; MICHAEL HOFFMANN; ANGELA KRUEGER;
Non FDA Participant/Group: Medical device industry and academia members

Event Date: 09/24/2021
Location: Virtual
Subject: 2021 Medical Device Manufacturers Association Medical Technology Executive Forum: CDRH Update
FDA Participant/Group: N/A
Non FDA Participant/Group: Medical device industry members

Event Date: 09/24/2021
Location: Virtual
Subject: 3D Dartmouth Device Development Symposium: A Conversation with the Director
FDA Participant/Group: N/A
Non FDA Participant/Group: Syd Finkelstein (Tuck School of Business at Dartmouth);

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

Event Date: 09/21/2021
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: N/A
Non FDA Participant/Group: National Association of State Departments of Agriculture

Official Name: William Slikker, Jr., Ph.D., Director, National Center for Toxicological Research

No Significant Event

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

No Significant Event