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: 09/27/2021
Location: Virtual
Subject: FasterCures Workshop: Building Community-Based Infrastructure for Inclusive Research
FDA Participant/Group: KEVIN BUGIN;
Non FDA Participant/Group: Government, industry, academia, and other invited guests

Event Date: 09/27/2021
Location: Virtual
Subject: Board of Governors Meeting and Planning Session
FDA Participant/Group: N/A
Non FDA Participant/Group: Members of Patient-Centered Outcomes Research Institute

Event Date: 09/28/2021
Location: Virtual
Subject: Public Workshop on COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics
FDA Participant/Group: KEVIN BUGIN;
Non FDA Participant/Group: Government, industry, academia, and other invited guests

Event Date: 09/28/2021
Location: Virtual
Subject: Public Meeting on the Recommendations for Prescription Drug User Fee Act (PDUFA) Reauthorization
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, academia, media, and other registered guests

Event Date: 09/29/2021
Location: Virtual
Subject: Accelerating Anticancer Drug Development and Validation Workshop: Strengthening the Clinical Trial Enterprise-Lessons from a Pandemic
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, academia, and other invited guests

Event Date: 09/29/2021
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: 09/28/2021
Location: Virtual
Subject: American Clinical Laboratory Association (ACLA) Listening Session
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Members of ACLA

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

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

Event Date: 09/29/2021
Location: Virtual
Subject: Food Safety Issues of Mutual Interest
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several staff and members of the Consumer Brands Association

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: 09/29/2021
Location: Virtual
Subject: Parenteral Drug Association / FDA Joint Regulatory Conference; Plenary Session 5 - FDA Updates
FDA Participant/Group: STEVEN SOLOMON; PETER MARKS; MATTHEW LUCIA; DOUGLAS THROCKMORTON;
Non FDA Participant/Group: Industry, academia, and other stakeholders

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: 09/27/2021
Location: Virtual
Subject: Parenteral Drug Association (PDA) /FDA Joint Regulatory Conference; Speaker: Plenary Session 1 and Q&A
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, other stakeholders

Event Date: 09/29/2021
Location: Virtual
Subject: Duke Fireside Chat
FDA Participant/Group: N/A
Non FDA Participant/Group: Murali Doraiswamy (Duke-Margolis Center for Health Policy);

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

Event Date: 09/29/2021
Location: Virtual
Subject: Cell & Gene Therapy USA 2021 Conference; FDA Insights: Advancing the Development of Cell and Gene Therapies; Keynote Speaker and Q&A
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, government, and other stakeholders

Event Date: 09/29/2021
Location: Virtual
Subject: Parenteral Drug Association (PDA) / FDA Joint Regulatory Conference; Speaker: CBER Updates; Bringing Bespoke Therapeutics into Being
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, government, and other stakeholders

Event Date: 09/30/2021
Location: Virtual
Subject: Interpublic Group Health 2021 Festival of Science Underway; Hypersonic Healthcare: The Accelerating Pace of Clinical Development and Demand for Data
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, government, and other stakeholders

Event Date: 10/01/2021
Location: Virtual
Subject: Infectious Disease (ID) Week 2021 Conference; Clinical Trial Lessons Learned from COVID-19: What Worked and What Didn't
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, government, and other stakeholders

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

Event Date: 09/27/2021
Location: Virtual
Subject: The MedTech Conference: Center for Devices and Radiological Health Town Hall
FDA Participant/Group: MICHELLE TARVER; DANIEL CANOS; WILLIAM MAISEL; HEATHER AGLER; BINITA ASHAR; TIMOTHY STENZEL; ARIEL SEELEY; DOUGLAS KELLY;
Non FDA Participant/Group: Medical Technology Professionals

Event Date: 09/29/2021
Location: Virtual
Subject: Opening Remarks: Next-Generation Sequencing and Radiomics Workshop: Resource Requirements for Acceleration of Clinical Applications Including AI
FDA Participant/Group: N/A
Non FDA Participant/Group: Members of the scientific community

Event Date: 09/30/2021
Location: Virtual
Subject: Council on Foreign Relations Roundtable Series on Public Health Preparedness and Response: Expanding the Public Health Toolkit: Improving Diagnostic Testing for COVID-19 and Future Pandemics
FDA Participant/Group: LUCIANA BORIO;
Non FDA Participant/Group: Leaders in International Affairs

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: 09/30/2021
Location: Virtual
Subject: Global Coalition on Regulatory Science Research Executive Committee Meeting
FDA Participant/Group: JUSTIN WIENCEK; SHRADDHA THAKKAR; ANIL KUMAR PATRI; WEIDA TONG;
Non FDA Participant/Group: Representatives of the Global Government Institution

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

Event Date: 09/27/2021
Location: Virtual
Subject: Meeting with Association for Accessible Medicines - GSK/Teva Litigation
FDA Participant/Group: JENNIFER GERTON; JANICE WEINER; MARYLL TOUFANIAN; ZAHAVA HURWITZ; CHRISTOPHER PRUITT; KIM DETTELBACH; SHOSHANA HUTCHINSON; ELIZABETH DICKINSON; MARIANNE TERROT;
Non FDA Participant/Group: David Gaugh , Jeffrey Francer, Karin Hessler, Lisa Parks (Association for Accessible Medicines); Willy Jay (Goodwin Proctor); Brian McCormick (Teva);