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  5. Public Calendar: May 1-7, 2022
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: May 1-7, 2022

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: Robert M. Califf, M.D., MACC, Commissioner of Food and Drugs

Event Date: 05/02/2022
Location: Virtual
Subject: Introductions and FDA Priorities
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Adrienne Archer, Jeanette Contreras, Milena Berhane, Nancy Glick, Sally Greenberg (National Consumer's League);

Event Date: 05/03/2022
Location: Virtual
Subject: World Medical Innovation Forum; Speaker: Fireside Chat
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, government, media and other registered guests

Event Date: 05/05/2022
Location: Virtual
Subject: Introductions and FDA Priorities
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Jack Resneck, Margaret Garikes, Shannon Curtis, Todd Askew (American Medical Association);

Official Name: Janet Woodcock, M.D., Principal Deputy Commissioner

Event Date: 05/04/2022
Location: Virtual
Subject: ACTIV-2/-3/-6 Trial Oversight Committee Meeting
FDA Participant/Group: PETER STEIN;
Non FDA Participant/Group: Parties involved in Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)

Event Date: 05/05/2022
Location: Washington, DC
Subject: rEVOLUTION 2022 - The Symposium for Chief Scientific Officers on Research and Development Issues; Fireside Chat - Regulatory Innovation During and After the Pandemic
FDA Participant/Group: N/A
Non FDA Participant/Group: Participants from industry, academia, and government

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

No Significant Event

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

No Significant Event

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: 05/06/2022
Location: Virtual
Subject: Listening Session: Lilly Decentralized Trial Practices and Community Engagement
FDA Participant/Group: MAARIKA KIMBRELL; LEONARD SACKS; MOHAMMED ELZARRAD; KEVIN BUGIN; SOFIA CHAUDHRY; JAMES SMITH; JACQUELINE CORRIGAN CURAY;
Non FDA Participant/Group: Carlos Garner, Lori Stephens (Lilly);

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

Event Date: 05/02/2022
Location: Virtual
Subject: World Medical Innovation Forum; Panelist: Regulatory Perspectives on Gene and Cell Therapy: Past Lessons, Current Challenges, Future Direction
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, industry, and government stakeholders

Event Date: 05/03/2022
Location: Virtual
Subject: World Medical Innovation Forum; Panelist: The Road Ahead: Regulatory Challenges for Cell and Gene Therapy
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, industry, and government stakeholders

Event Date: 05/03/2022
Location: Virtual
Subject: Charles River 5th Annual World Congress; Speaker: Keeping Pace with Cell & Gene Therapy Regulations
FDA Participant/Group: N/A
Non FDA Participant/Group: Academic scientists, biopharmaceutical companies, disease foundations, and regulatory authorities

Event Date: 05/04/2022
Location: Virtual
Subject: Longwood Healthcare Leaders Spring Meeting; Speaker: Regulatory Keynote Address
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia and industry stakeholders

Event Date: 05/05/2022
Location: Virtual
Subject: COVID-19 Updates: Booster Doses
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the National Foundation for Infectious Diseases webinar

Event Date: 05/06/2022
Location: Virtual
Subject: International Society for Cell & Gene Therapy Annual Meeting; Speaker: Pitfalls in Late Stage Chemistry, Manufacturing and Controls (CMC): What’s the Solution?
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, industry, and government stakeholders

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

Event Date: 05/04/2022
Location: Virtual
Subject: MedCon Conference; Speaker: CDRH’s Strategic Direction for 2022
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, and government

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

No Significant Event

Official Name: Michele Mital, Acting Director, Center for Tobacco Products

No Significant Event

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

No Significant Event

Official Name: Tucker Patterson, Ph.D., Acting Director, National Center for Toxicological Research

No Significant Event

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

Event Date: 05/03/2022
Location: Silver Spring, MD
Subject: Very Low Nicotine Product Approvals
FDA Participant/Group: SHOSHANA HUTCHINSON; CELESTE WHEELER; ROBIN APPLEBERRY; RANDOLPH KLINE; SARAH STEWART; DAVID MEDNICK; THOMAS SUNDLOF; ELIZABETH DICKINSON; DANLI SONG;
Non FDA Participant/Group: Denny Henigan (Campaign for Tobacco Free Kids); William Schultz (Zuckerman Spaeder);

 

 
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