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: 05/18/2021
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Speaker: Keynote Address
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, media, government, and other registered guests

Event Date: 05/19/2021
Location: Virtual
Subject: Clinical Trial Diversity
FDA Participant/Group: N/A
Non FDA Participant/Group: Richard Moscicki (Pharmaceutical Research and Manufacturers of America);

Event Date: 05/19/2021
Location: Virtual
Subject: Second Annual National Instutites of Health Helping to End Addiction Long-term (HEAL) Initiative; Panelist: Moving Research Into Action
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, academia, media, and other registered guests

Event Date: 05/19/2021
Location: Virtual
Subject: Listening Session with the American Brain Coalition
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Katie Sale, Mark Rasenick, Matthew Rizzo, Timothy Coetzee (American Brain Coalition); Becca Branum, Lyle Dennis, Meghan Riley (CRD Associates);

Event Date: 05/19/2021
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: 05/20/2021
Location: Virtual
Subject: Foundation for the National Institutes of Health Annual Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Several Foundation for the National Institues of Health board members, government, and other registered guests

Official Name: Andi Lipstein Fristedt, 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: 05/21/2021
Location: Virtual
Subject: Leafy Greens Issues of Mutual Interest
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representative Jimmy Panetta (D-CA)

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

Event Date: 05/19/2021
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) 2021 Annual Conference; Panelist: Supply Chains in a Post-Pandemic World
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, media, government, and other registered guests

Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs

Event Date: 05/19/2021
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Speaker: Keynote Address
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, media, government, and other registered guests

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: 05/20/2021
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Speaker: Update on CDER Issues
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, media, government, and other registered guests

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

Event Date: 05/17/2021
Location: Virtual
Subject: American College of Preventive Medicine Annual Conference; Speaker: Building Vaccine Confidence, U.S. Regulatory Safety Practices
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, media, government, and other registered guests

Event Date: 05/19/2021
Location: Virtual
Subject: Advanced Therapies Congress and Expo 2021; Panel Chair: How to Ensure Clinical Success
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, media, government, and other registered guests

Event Date: 05/20/2021
Location: Virtual
Subject: Gene Fixers Clubhouse; Speaker: Individualized Medicines Post COVID
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders

Event Date: 05/20/2021
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Speaker: Update on CBER Issues
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, media, government, and other registered guests

Event Date: 05/21/2021
Location: Virtual
Subject: Advanced Therapies Congress and Expo 2021; Panelist: Tackling Large-scale, Commercial Regulatory Challenges
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, media, government, and other registered guests

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

Event Date: 05/19/2021
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Speaker: CDRH Priorities and Goals
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, media, government, and other registered guests

Event Date: 05/20/2021
Location: Virtual
Subject: Total Product Lifecyle Advisory Program
FDA Participant/Group: MALCOLM BERTONI; OWEN FARIS; LAUREN ROTH; DOUGLAS KELLY;
Non FDA Participant/Group: Michael Mussallem (Edwards Lifesciences Corp); Lisa Earnhardt (Abbott); Todd Pope (WellAir); Mike Minogue (ABIOMED Inc); Janet Trunzo, Scott Whitaker (AdvaMed); Lishan Aklog (PAVmed); Kevin Lobo (Stryker); Martha Shadan (Miach Orthopaedics ); Maureen Mulvihill (Actuated Medical, Inc); Nadim Yared (CVRx);

Official Name: Susan T. Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition

Event Date: 05/18/2021
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Speaker: Update on CFSAN Issues
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Food and Drug Law Institute (FDLI)

Official Name: Mitchell R. Zeller, J.D., Director, Center for Tobacco Products

Event Date: 05/17/2021
Location: Virtual
Subject: General CTP Stakeholder Update
FDA Participant/Group: N/A
Non FDA Participant/Group: Truth Initiative senior leadership

Event Date: 05/18/2021
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Speaker: Update on CTP Issues
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, media, government, and other registered guests

Official Name: Steven Solomon, Director, Center for Veterinary Medicine

Event Date: 05/19/2021
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Speaker: Update on CVM Issues
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, media, government, and other registered guests

Event Date: 05/21/2021
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: PATRICK MCDERMOTT; ANTONIA MONIQUE SENNETT; WILLIAM FLYNN; AMBER MCCOIG; NADINE STEINBERG; CINDY BURNSTEEL; TRACEY FORFA; ASHLEY STEEL; MATTHEW LUCIA; SHANNON RUTHERFORD; ANNE NORRIS;
Non FDA Participant/Group: Representatives of The Pew Charitable Trusts

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

Event Date: 05/18/2021
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Speaker: Keynote Address
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, media, government, and other registered guests