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: 06/20/2023
Location: Silver Spring, MD
Subject: Prescription Drug User Fee Act (PDUFA) VII Implementation Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: James Stansel, Kelly Goldberg, Kristy Lupejkis, Lucy Vereshchagina, Sebastian Guth, Stephen Ubl (Pharmaceutical Research and Manufacturers of America (PhRMA)); Cartier Esham, Mike Raab, Richard Pops (Biotechnology Innovation Organization (BIO));

Event Date: 06/22/2023
Location: Aspen, CO
Subject: Aspen Ideas: Health 2023; Speaker: Regulating 20% of U.S. Economy
FDA Participant/Group: MICHAEL FELBERBAUM;
Non FDA Participant/Group: Government, industry, media, academia, and other registered guests

Event Date: 06/23/2023
Location: Aurora, CO
Subject: University of Colorado Anschutz Medical Campus Tour and Roundtable
FDA Participant/Group: KIMBERLEE TRZECIAK;
Non FDA Participant/Group: Government and academia

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

Event Date: 06/21/2023
Location: Virtual
Subject: Potential Collaborations
FDA Participant/Group: MELISSA SAFFORD; KATHERINE BRILL; DONALD PRATER; REBECCA BUCKNER;
Non FDA Participant/Group: Autumn Price, Mark Bushway, Matt Echols, Sandy Douglas, Tehzin Chadwick (United Natural Foods, Inc. (UNFI));

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: 06/19/2023
Location: Geneva, Switzerland
Subject: Access to Medicines and Health Products Priorities
FDA Participant/Group: LEIGH VERBOIS, RUSSELL CAMPBELL
Non FDA Participant/Group: Yukiko Nakatani (World Health Organization, Access to Medicines and Health Products);

Event Date: 06/19/2023
Location: Geneva, Switzerland
Subject: Prequalification Cooperation Opportunities
FDA Participant/Group: LEIGH VERBOIS, RUSSELL CAMPBELL
Non FDA Participant/Group: Rogerio Pinto de Sá Gaspa (World Health Organization, Regulation and Prequalification);

Event Date: 06/19/2023
Location: Geneva, Switzerland
Subject: Nutrition Issues
FDA Participant/Group: LEIGH VERBOIS, RUSSELL CAMPBELL
Non FDA Participant/Group: Francesco Branca (World Health Organization, Nutrition for Health and Development);

Event Date: 06/20/2023
Location: Geneva, Switzerland
Subject: Steering Committee Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Representatives of the Member State Mechanism on Substandard and Falsified Medical Products Steering Committee

Official Name: Carol Cave, Acting Associate Commissioner for Regulatory Affairs

No Significant Event

Official Name: Heidi Rebello, Acting Associate Commissioner for External Affairs

No Significant Event

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

Event Date: 06/23/2023
Location: East Lansing, MI
Subject: 49th Annual Midwest Pharmacology Colloquium; Keynote Address
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, industry, and other stakeholders

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

Event Date: 06/21/2023
Location: Virtual
Subject: Collaboration, Regulations, Training, and Quality Issues
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives of the Indian Pharmaceutical Association (IPA)

Event Date: 06/22/2023
Location: Virtual
Subject: Patient Led Focus Group on Prader-Willis Syndrome; Opening Remarks
FDA Participant/Group: N/A
Non FDA Participant/Group: Various members and participants from the Prader-Willis Syndrome Association

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

Event Date: 06/22/2023
Location: Tysons Corner, VA
Subject: Centre for Innovation in Regulatory Science Workshop; Consideration of Uncertainty Within FDA's Benefit-Risk Framework
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the Centre for Innovation in Regulatory Science Workshop

Event Date: 06/23/2023
Location: King of Prussia, PA
Subject: @Philly Cell and Gene Therapy 2023 Annual Conference; Expediting the Development and Availability of Gene Therapy
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the @Philly Cell and Gene Therapy 2023 Annual Conference

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

Event Date: 06/22/2023
Location: Silver Spring, MD
Subject: Multi-Cancer Early Detection Test
FDA Participant/Group: WILLIAM MAISEL; DANIEL EDELMAN; DONNA ROSCOE; ANAND PATHAK; SOMA GHOSH; TIMOTHY STENZEL; CATHERINE FISCHER; BRITTANY SCHUCK;
Non FDA Participant/Group: Lakshman Ramamurthy, Josh Ofman, Abram Barth, Eric Fung, Margaret McCusker, Linda Peters, Neda Ronaghi (GRAIL, LLC)

Official Name: Donald Prater, Acting Director, Center for Food Safety and Applied Nutrition

Event Date: 06/20/2023
Location: Virtual
Subject: Nutrition Consumer and Public Health Stakeholder Meeting: Added Sugars, Menu Labeling, Front Package Labeling, and Guidance Statements
FDA Participant/Group: LAURA CARROLL; LINDSAY HAAKE; DOUGLAS BALENTINE; EMILY ROSE CAREY; PATRICIA HANSEN; JENNIFER DOOREN; ROBIN MCKINNON; CHRISTOPHER WALDROP; KARI BARRETT;
Non FDA Participant/Group: Christina Roberto (Phychology of Eating and Consumer Health Lab); Teresa Conigliaro, Liz Solomon (New York City Department of Health and Mental Hygiene); Eva Greenthal, Sarah Sorscher, Aviva Musicus (Center for Science in the Public Interest); Madison West (Trust for America's Health); Robin Thurston (Democracy Forward); Sarah Ohlhorst (American Society for Nutrition); Madeline Curtis (American Academy of Pediatrics); Sarah Rogers (Association of State Public Health Nutritionist); Marrisa Hall (Department of Health Behavior, University of North Carolina);

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

Event Date: 06/19/2023
Location: Geneva, Switzerland
Subject: World Health Organization’s (WHO) Global Workshop on Flavors; Keynote: Keeping Pace with the Evolving Landscape of Youth Appealing E-cigarettes
FDA Participant/Group: ESHAEL JOHNSON;
Non FDA Participant/Group: Several regulatory experts from the six regions of World Health Organization (WHO)

Event Date: 06/21/2023
Location: Geneva, Switzerland
Subject: World Health Organization’s (WHO) Global Consultation on Novel Emerging Nicotine and Tobacco Products; Keynote: Regulatory Approach to Electronic Nicotine Delivery Systems (ENDS) in the United States
FDA Participant/Group: ESHAEL JOHNSON;
Non FDA Participant/Group: Several regulatory experts from non-governmental organizations (NGOs), scientists, government regulators

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