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  5. Public Calendar: April 16-22, 2023
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: April 16-22, 2023

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 for Food and Drugs

Event Date: 04/18/2023
Location: Virtual
Subject: Nutrition Stakeholder Call
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Stakeholders from multiple sectors

Event Date: 04/20/2023
Location: Virtual
Subject: COVID Bivalent Vaccines Stakeholder Call
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Stakeholders from multiple sectors

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

Event Date: 04/18/2023
Location: Medford, MA
Subject: Introductory Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Thai delegation including Princess Chulabhorn and other Thai diplomatic officials; Ram Sasisekharan (Massachusetts Institute of Technology)

Event Date: 04/18/2023
Location: Medford, MA
Subject: Health Summit on Tufts University One Health: Health Security and Drug Development in the Post-COVID World
FDA Participant/Group: INGRID MARKOVIC; ELLEN HART;
Non FDA Participant/Group: Academia, government, and other stakeholders

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: Mark Abdoo, Associate Commissioner for Global Policy and Strategy

Event Date: 04/17/2023
Location: Silver Spring, MD
Subject: Priorities and Future Areas of Collaboration
FDA Participant/Group: DONALD PRATER; NICOLE CONKLIN; RAVI BHARWANI;
Non FDA Participant/Group: Lloyd Day, Margaret Zeigler (Inter-American Institute for Cooperation in Agriculture); Julie Ross (Health Resources and Services Administration (HRSA));

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: Namandjé N. Bumpus, Ph.D., Chief Scientist

No Significant Event

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

Event Date: 04/17/2023
Location: Virtual
Subject: Sponsor Meeting on NDA 217188 – Paxlovid – Proposed Labeling
FDA Participant/Group: N/A
Non FDA Participant/Group: Pfizer representatives

Event Date: 04/19/2023
Location: Virtual
Subject: Overview of Decentralized Clinical Trials
FDA Participant/Group: N/A
Non FDA Participant/Group: Yasuhiro Fujiwara, Yoshiko Komuro, Yuma Yokoi (Pharmaceuticals and Medical Devices Agency (PMDA)); Kazutaka Ikeda, Kazuyuki Mkagome (National Center of Neurology and Psychiatry (NCNP));

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

Event Date: 04/20/2023
Location: Washington, DC
Subject: National Academies of Sciences, Engineering, and Medicine’s Workshop: U.S. Legal and Regulatory Frameworks for a Translational Pathway from Lab to Clinical Trials for In-vitro Gametogenesis (IVG)
FDA Participant/Group: N/A
Non FDA Participant/Group: Scientific, ethical, and regulatory stakeholders

Event Date: 04/20/2023
Location: Virtual
Subject: Primary Immune Deficiency Treatment Consortium Annual Scientific Workshop; Roundtable: The Complicated Barriers to Bringing Gene Therapies Forward to Clinical Availability
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, research, and patient advocate 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

Event Date: 04/21/2023
Location: Virtual
Subject: Issues of Mutual Interest
FDA Participant/Group: JESSICA ROWDEN; PAUL SOUTH; CHRISTOPHER WALDROP; KRISTI MULDOON JACOBS; KARI BARRETT; PATRICIA HANSEN; JENNIFER DOOREN; LYNN SZYBIST; MICHAEL ROGERS; DONALD PRATER;
Non FDA Participant/Group: Cortney Bidney, Julie Culp (General Mills); Roberta Wagner (Consumer Brands Association); Brent Koblelush (Conagra);

Official Name: Brian King, Ph.D., Director, Center for Tobacco Products

Event Date: 04/17/2023
Location: Orlando, FL
Subject: American Association for Cancer Research (AACR) Annual Meeting; Keynote Speaker: FDA Center for Tobacco Products’ Priorities to Address Tobacco Use and Support the Cancer Moonshot
FDA Participant/Group: KARIN RUDOLPH;
Non FDA Participant/Group: Several representatives from and attendees of the American Association for Cancer Research Annual Meeting

Event Date: 04/18/2023
Location: Leesburg, VA
Subject: Tobacco Merchant’s Association (TMA) Annual Meeting; Keynote Speaker: Updates from FDA’s Center for Tobacco Products
FDA Participant/Group: N/A
Non FDA Participant/Group: Several representatives from and attendees of the Tobacco Merchants Association Annual Meeting

Official Name: Tracey H. Forfa, J.D., Director, Center for Veterinary Medicine

No Significant Event

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

No Significant Event

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

No Significant Event

 

 
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