Public Calendar: October 17-23, 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: 10/18/2021
Location: Virtual
Subject: Reagan Udall Foundation: A Practical Research Agenda for Treatment Development for Stimulant Use Disorder
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, academia, industry, and other invited guests

Event Date: 10/18/2021
Location: Virtual
Subject: The National Organization for Rare Disorders (NORD) Rare Disease and Orphan Products Summit
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, academia, industry, media, and other registered participants

Event Date: 10/19/2021
Location: Virtual
Subject: National Institutes of Health Tobacco Regulatory Science Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, academia, and other invited guests

Event Date: 10/19/2021
Location: Virtual
Subject: New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, academia, industry, media, and other registered participants

Event Date: 10/20/2021
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: 10/21/2021
Location: Virtual
Subject: Foundation for the National Institutes of Health Board of Directors Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Board members of the Foundation for the National Institues of Health

Event Date: 10/22/2021
Location: Virtual
Subject: COVID-19 Vaccine Booster Doses
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Healthcare professionals, industry, state and local public health organizations

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

Event Date: 10/20/2021
Location: Virtual
Subject: Medical Device User Fee Act (MDUFA) Update
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives from industry and congressional members and staff

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

Event Date: 10/20/2021
Location: Virtual
Subject: U.S. – EU Mutual Recognition Agreement (MRA) 7th Joint Sectoral Committee Meeting
FDA Participant/Group: JOSEPH RIERAS, JADE PHAM, ELIZABETH MILLER, SUSAN LASKA, STEVEN SOLOMON, THERESA MULLIN, MARY MALARKEY
Non FDA Participant/Group: Members of the European Commission - Directorate General Health and Food Safety (SANTE) Unit B4 – Medical Products: Quality, Safety and Innovation

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: Jacqueline O'Shaughnessy, Acting Chief Scientist

No Significant Event

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

Event Date: 10/21/2021
Location: Virtual
Subject: International Coalition of Medicines Regulatory Authorities (ICMRA) Executive Committee Meeting
FDA Participant/Group: PETER MARKS;
Non FDA Participant/Group: Members of the ICMRA Executive Committee

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

Event Date: 10/19/2021
Location: Virtual
Subject: Facilitating the Development and Availability of COVID-19 Vaccines
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the University of Chicago Medicine Grand Rounds’ 2021 Leon I. Goldberg Memorial Lecture

Event Date: 10/21/2021
Location: Virtual
Subject: Closing Keynote Presentation: Expediting the Development of Vaccines for Public Health Emergencies; Panelist: Regulatory Roundtable Discussion, Part II
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the Clinical Data Interchange Standards Consortium (CDISC) 2021, U.S. Interchange Conference

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

Event Date: 10/18/2021
Location: Virtual
Subject: International Conference on Medical Device Standards and Regulation; Keynote Speaker: Ensuring the Safety and Effectiveness of Medical Devices Across the Product Lifecylce
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Regulatory authorities, standards development organizations, and medical device industry members

Event Date: 10/21/2021
Location: Virtual
Subject: Medtronic Patient Safety and Quality Improvement Plan Update
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several Medtronic staff

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: 10/21/2021
Location: Virtual
Subject: Fetal Pharmacology and Therapeutics Workshop; Moderator: Advances in Fetal Pharmacology and Therapeutics
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Academia, government, and industry

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

No Significant Event