Public Calendar: June 13-19, 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: 06/15/2021
Location: Virtual
Subject: Summit on Anti-SARS-CoV-2 Antibodies for Treatment and Prevention of COVID-19: Lessons Learned and Remaining Questions
FDA Participant/Group: PETER MARKS; CHRISTOPHER ELLIS;
Non FDA Participant/Group: Industry, government, academia, and other registered guests
Event Date: 06/16/2021
Location: Virtual
Subject: Continuing the Conversation: FDA and CDC Leaders Discuss the COVID-19 Pandemic, Vaccines and Special Considerations for the Rare Disease Community
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, government, and other registered guests
Event Date: 06/16/2021
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: 06/17/2021
Location: Virtual
Subject: Biotechnology Innovation Organization Digital Convention; Fireside Chat
FDA Participant/Group: JAMES SMITH; PETER MARKS; PATRIZIA CAVAZZONI;
Non FDA Participant/Group: Industry, government, academia, media, and other registered guests
Official Name: Andi Lipstein Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs
Event Date: 06/14/2021
Location: Virtual
Subject: National Academy for State Health Policy (NASHP) State Rx Drug Importation from Canada Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives from National Academy for State Health Policy
Official Name: Jim Sigg, Deputy Commissioner for Operations
No Significant Event
Official Name: Frank Yiannas, Deputy Commissioner for Food Policy and Response
Event Date: 06/15/2021
Location: Virtual
Subject: Association of Food and Drug Officials Annual Educational Conference; Speaker: Food Policy and Response Update
FDA Participant/Group: N/A
Non FDA Participant/Group: Professionals from government, states, academia, consumer groups and manufacturing
Event Date: 06/16/2021
Location: Virtual
Subject: Alliance for a Stronger FDA Food Safety and Animal Health Webinar
FDA Participant/Group: SUSAN MAYNE; STEVEN SOLOMON;
Non FDA Participant/Group: Participants from industry, consumer and patient advocates, research advocacy, and other stakeholders
Official Name: Mark Abdoo, Associate Commissioner for Global Policy and Strategy
Event Date: 06/16/2021
Location: Virtual
Subject: Collaboration Opportunities for Food Safety
FDA Participant/Group: N/A
Non FDA Participant/Group: Francesco Branca (World Health Organization);
Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs
Event Date: 06/14/2021
Location: Virtual
Subject: Association of Food and Drug Officials (AFDO) Virtual Conference Program; Panel: U.S. Food and Drug Administration Regulatory Affairs Update
FDA Participant/Group: MICHAEL ROGERS; CAROL CAVE; ERIK METTLER; GLENDA BARFELL;
Non FDA Participant/Group: Participants from industry, academia, government, 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: 06/14/2021
Location: Virtual
Subject: Genetic Disorders and Familial Support
FDA Participant/Group: N/A
Non FDA Participant/Group: Ethan Perlstein, Julia Vitarello (Perlara);
Event Date: 06/14/2021
Location: Virtual
Subject: Aducanumab Postmarketing Requirements (PMR) Under Accelerated Approval
FDA Participant/Group: PETER STEIN; JACQUELINE CORRIGAN CURAY;
Non FDA Participant/Group: Alfred Sandrock, Michael Vounatsos (Biogen);
Event Date: 06/16/2021
Location: Virtual
Subject: Consumer Healthcare Products Association (HCPA) Board of Directors Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Members of HCPA board of directors
Event Date: 06/16/2021
Location: Virtual
Subject: Duke Margolis - FDA Opioid Convening Meeting
FDA Participant/Group: GERALD DALPAN; MARTA SOKOLOWSKA;
Non FDA Participant/Group: Katie Greene, Marianne Lopez, Thomas Roades (Duke-Margolis Center for Health Policy);
Official Name: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
Event Date: 06/15/2021
Location: Virtual
Subject: National Institutes of Health Summit on Anti-SARS-CoV-2 Antibodies for Treatment and Prevention of COVID-19; Speaker: State of the Science Presentations: Convalescent Plasma and Hyperimmune Globulin
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees from industry, academia, and other stakeholders
Event Date: 06/17/2021
Location: Virtual
Subject: National Institutes of Health Virtual Roundtable on Gene-Targeted Therapies: Early Diagnosis and Equitable Delivery; Panelist: Bioethics, Regulatory Challenges and Equity
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees from industry, academia, and other stakeholders
Event Date: 06/17/2021
Location: Virtual
Subject: National Institutes of Health Virtual Roundtable on Gene-Targeted Therapies: Early Diagnosis and Equitable Delivery; Speaker: FDA’s Regulatory Framework for Gene Therapy
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees from industry, academia, and other stakeholders
Official Name: Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health
No Significant Event
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: Mark Raza, J.D., Acting Chief Counsel
No Significant Event