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: 05/17/2023
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Speaker: Keynote Address
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, media, and other registered attendees

Event Date: 05/18/2023
Location: Virtual
Subject: Foundation for the National Institutes of Health Board of Directors Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Several board members of the Foundation for the National Institutes of Health

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

No Significant Event

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

Event Date: 05/17/2023
Location: Washington, DC
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Panelist: Recent Congressional Actions and the Impacts on FDA, Regulated Industry, and Public Health
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, media, and other registered attendees

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

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

Event Date: 05/18/2023
Location: Washington, D.C.
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Panelist: Global Supply Chain Resilience: The Role of Government and Stakeholders
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, media, and other registered attendees

Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs

Event Date: 05/18/2023
Location: Virtual
Subject: ORA / Bioresearch Monitoring (BIMO) Inspectional Activity Roundtable; Opening Remarks
FDA Participant/Group: JUDITH MCMEEKIN; ELIZABETH MILLER; DAVID BURROW; CHRISSY COCHRAN;
Non FDA Participant/Group: Jessica Palfreyman, Lea Ann McNee, Susan Winckler (Reagan Udall);

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: 05/15/2023
Location: Washington, DC
Subject: FDA Accelerated Approval Process
FDA Participant/Group: PETER MARKS;
Non FDA Participant/Group: Several representatives from the National Academies Sciences, Engineering, and Medicine’s Committee on Science, Technology, and Law

Event Date: 05/16/2023
Location: Silver Spring, MD
Subject: State of the Industry Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Pharma and Biopharma Outsourcing Association (PBOA) member company executives

Event Date: 05/18/2023
Location: Washington, DC
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Speaker: CDER Updates
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, media, and other registered attendees

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

Event Date: 05/15/2023
Location: Virtual
Subject: Ocular Diseases Forum 1 - Understanding the Global Regulatory Perspective; Speaker: Regulatory Landscape in the United States
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, industry, professional societies, patient representatives, and regulatory stakeholders

Event Date: 05/15/2023
Location: Virtual
Subject: Pharma Manufacturing World Summit: Quality and Compliance from the Regulators’ Perspective
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry stakeholders

Event Date: 05/17/2023
Location: Virtual
Subject: American Society of Gene and Cell Therapy 26th Annual Meeting; Panelist: Accelerated Approval for Cell and Gene Therapies
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, healthcare, industry, regulatory, and patient advocate stakeholders

Event Date: 05/17/2023
Location: Washington, DC
Subject: Food and Drug Law Institute Annual Conference: Center for Biologics Evaluation and Research Updates
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, non-profits, patient and consumer advocates, and academia stakeholders

Event Date: 05/18/2023
Location: Virtual
Subject: American Society of Gene and Cell Therapy; Speaker: A Fireside Chat on Emerging Regulatory Trends
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, healthcare, industry, regulatory, and patient advocate stakeholders

Event Date: 05/19/2023
Location: Rockville, MD
Subject: The Role of Biomarkers in the Development of Gene Therapy for Rare Diseases
FDA Participant/Group: N/A
Non FDA Participant/Group: Several representatives from the Foundation for the National Institutes of Health’s Biomarkers Consortium Executive Committee

Event Date: 05/20/2023
Location: Virtual
Subject: Bespoke Gene Therapy Consortium Annual Meeting; Panelist: Accelerating Medicines Partnership Program
FDA Participant/Group: N/A
Non FDA Participant/Group: Several representatives from the Bespoke Gene Therapy Consortium

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

Event Date: 05/16/2023
Location: Silver Spring, MD
Subject: Alaris 510(k) and Cybersecurity
FDA Participant/Group: LINDA RICCI; JESSICA WILKERSON; MATTHEW HAZELETT; WILLIAM MAISEL; KEISHA THOMAS; JULIANE LESSARD; JAKE LINDSTROM; SUZANNE SCHWARTZ; COURTNEY LIAS;
Non FDA Participant/Group: Tom Polen, Ami Simunovich, William Sigmund, Elizabeth McCombs, Mark O’Donnell, Kay Taylor, (Becton, Dickinson and Company)

Event Date: 05/18/2023
Location: Silver Spring, MD
Subject: Orthopedic Advisory Panel
FDA Participant/Group: WILLIAM MAISEL; SARA THOMPSON; CHRISTOPHER HARNER; RAQUEL PEAT; LAURENCE COYNE; TRAVIS PREST; VINCENT DEVLIN; MARC DEHART;
Non FDA Participant/Group: Ryan Belaney, (Active Implants,LLC), Henry Klyce, (Active Implants, LLC), Deryk Jones, (Oshner Sports Medicine), David Flanigan, (Wexner Ohio State University), Janice Hogan, (Hogan Lovells)

Event Date: 05/18/2023
Location: Washington, DC
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Speaker: CDRH Updates
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, media, and other registered attendees

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

Event Date: 05/16/2023
Location: Washington DC and Virtual
Subject: National Advisory Committee Public Meeting on Microbiological Criteria for Foods (NACMCF)
FDA Participant/Group: BENJAMIN WARREN; ERIC OLSON;
Non FDA Participant/Group: Elisabetta Lamertini (Global Alliance for Improved Nutrition); Emillio Esteban, Kristal Southern (United States Department of Agriculture); Peggy Cook (Neogen Corporation); Kathleen Glass (Food Research Institute); Max Teplitski (Fresh Produce Association);

Event Date: 05/17/2023
Location: Washington DC
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Speaker: CFSAN Updates
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, media, and other registered attendees

Event Date: 05/19/2023
Location: Virtual
Subject: Nutrition Initiatives
FDA Participant/Group: ROBIN MCKINNON;
Non FDA Participant/Group: Molly Fogarty (Nestle);

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

Event Date: 05/16/2023
Location: Virtual
Subject: U.S. Tobacco Regulatory Updates
FDA Participant/Group: N/A
Non FDA Participant/Group: Ann McNeil (King's College London);

Event Date: 05/16/2023
Location: Washington, DC
Subject: E-Cigarette Summit; Speaker: FDA’s Comprehensive Approach to Tobacco Regulation
FDA Participant/Group: N/A
Non FDA Participant/Group: Several Summit attendees from Industry and public health stakeholders.

Event Date: 05/17/2023
Location: Virtual
Subject: Center for the Assessment of Tobacco Regulations (CAsToR) Symposium; Speaker: The Use of Modeling in Tobacco Regulatory Science - Insights from CTP
FDA Participant/Group: N/A
Non FDA Participant/Group: Several CAsToR Symposium 2023 attendees representing public health stakeholders.

Event Date: 05/18/2023
Location: Washington, DC
Subject: The Campaign for Tobacco Free Kids (CTFK) Annual Youth Advocate of the Year Awards (YAYA) Gala
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Organizational and other stakeholders

Event Date: 05/18/2023
Location: Washington, DC
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Speaker: CTP Update
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, media, and other registered attendees

Event Date: 05/19/2023
Location: Virtual
Subject: New Jersey Prevention Annual Addiction Conference; Speaker: Overview of CTP, Tobacco Product Regulations, and How Communities Can Support Regulatory Compliance
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees representing public health stakeholders

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

Event Date: 05/17/2023
Location: Arlington, VA
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: TIMOTHY SCHELL;
Non FDA Participant/Group: Representatives of the American Feed Industry Association (AFIA)

Event Date: 05/18/2023
Location: Washington, DC
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Speaker: CVM Update
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, media, and other registered attendees

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

No Significant Event

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

Event Date: 05/17/2023
Location: Washington, DC
Subject: Food and Drug Law Institute (FDLI) Annual Conference; Speaker: Keynote Address
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, media, and other registered attendees