Public Calendar: October 15-21, 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: 10/16/2023
Location: Boston, MA
Subject: Translational Science Day 2023: Advancing Health Equity Through Translational Science
FDA Participant/Group: CHANAPA TANTIBANCHACHAI;
Non FDA Participant/Group: Industry, government, and academia
Event Date: 10/16/2023
Location: Virtual
Subject: 2023 International Society for Pharmaceutical Engineering (ISPE) Annual Meeting and Expo
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, media, and government
Event Date: 10/17/2023
Location: Washington, DC
Subject: National Organization for Rare Disorders (NORD) Rare Diseases and Orphan Products Breakthrough Summit
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, government, academia, and media
Event Date: 10/17/2023
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 (PhRMA); Richard Pops, Cartier Esham, Rachel King (BIO); Mike Raab (Ardelyx);
Event Date: 10/18/2023
Location: Washington, DC
Subject: National Academy of Medicine's Leadership Consortium - Strategies to Improve Evidence Development for Health Improvement: Focus on Public Health Data Governance Processes
FDA Participant/Group: JILL WASSERMAN;
Non FDA Participant/Group: Industry, academia, and government
Event Date: 10/18/2023
Location: Washington, DC
Subject: Foundation for the National Institutes of Health (FNIH) 11th Annual Awards Ceremony
FDA Participant/Group: N/A
Non FDA Participant/Group: Several members of the Foundation for the National Institutes of Health, industry, academia, government, and other invited individuals
Event Date: 10/19/2023
Location: Virtual
Subject: Meeting with Cancer Centers
FDA Participant/Group: ANDREW ZACHER;
Non FDA Participant/Group: Government and academia
Event Date: 10/19/2023
Location: Virtual
Subject: Foundation for the National Institutes of Health (FNIH) Board of Directors Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Several members of the FNIH Board of Directors and staff
Official Name: Janet Woodcock, M.D., Principal Deputy Commissioner
Event Date: 10/18/2023
Location: Virtual
Subject: FDA / Clinical Trials Transformation Initiative (CTTI) Public Meeting - Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies; Speaker: Opening Remarks
FDA Participant/Group: JACQUELINE CORRIGAN CURAY; JULIENNE VAILLANCOURT; MOHAMMED ELZARRAD; KAREN HICKS; JOHN FARLEY;
Non FDA Participant/Group: Academia and other stakeholders
Official Name: Jim Jones, Deputy Commissioner for Human Foods
Event Date: 10/16/2023
Location: Virtual
Subject: Introductory Meeting
FDA Participant/Group: KARI BARRETT;
Non FDA Participant/Group: Molly Fogarty (Nestlé);
Event Date: 10/18/2023
Location: Washington, DC
Subject: Introductory Meeting
FDA Participant/Group: DANIEL HATTIS;
Non FDA Participant/Group: Representative Brett Guthrie (R-KY)
Event Date: 10/18/2023
Location: Washington, DC
Subject: Introductory Meeting
FDA Participant/Group: DANIEL HATTIS;
Non FDA Participant/Group: Representative Sanford Bishop (D-GA)
Event Date: 10/18/2023
Location: Washington, DC
Subject: Introductory Meeting
FDA Participant/Group: DANIEL HATTIS;
Non FDA Participant/Group: Representative Rosa DeLauro (D-CT)
Event Date: 10/18/2023
Location: Washington, DC
Subject: Introductory Meeting
FDA Participant/Group: MATTHEW LOCKEED;
Non FDA Participant/Group: Representative Anna Eshoo (D-CA)
Event Date: 10/18/2023
Location: Washington, DC
Subject: Introductory Meeting
FDA Participant/Group: MATTHEW LOCKEED;
Non FDA Participant/Group: Representative Jimmy Panetta (D-CA)
Event Date: 10/20/2023
Location: Virtual
Subject: Introductory Meeting / Food Safety Issues of Mutual Interest
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Anupama Joshi, Aviva Musicus, Colin Schwartz, Peter Lurie, Sarah Sorscher (Center for Science in the Public Interest);
Official Name: Kimberlee Trzeciak, 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
No Significant Event
Official Name: Michael Rogers, Acting Associate Commissioner for Regulatory Affairs
Event Date: 10/17/2023
Location: Virtual
Subject: 2023 FDA / Association of American Feed Control Officials (AAFCO) Annual Briefing and Planning Conference
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Members of the Association of American Feed Control Officials (AAFCO)
Official Name: Leah Hunter, 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: 10/16/2023
Location: Washington, DC
Subject: National Organization for Rare Disorders (NORD) Rare Diseases and Orphan Products Breakthrough Summit; Speaker: Moving Diversity, Equity, and Inclusion (DEI) from Good Intentions to Effective Action
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders
Event Date: 10/17/2023
Location: Silver Spring, MD
Subject: Consumer Healthcare Product Association (CHPA) Listening Session
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: David Spangler, Lauren Quinn, Lisa Paley, Lisa Parks, Scott Melville (Consumer Healthcare Product Association (CHPA));
Official Name: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
Event Date: 10/16/2023
Location: Washington, DC
Subject: National Organization for Rare Disorders (NORD) Rare Diseases and Orphan Products Breakthrough Summit; Speaker: Regulatory Landscape for Genome Editing
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, research, medical, patient advocate, and government stakeholders
Event Date: 10/17/2023
Location: Washington, DC
Subject: National Academies of Sciences, Engineering, and Medicine Forum on Regenerative Medicine Public Workshop; Keynote: Emerging Technologies and Innovation in Manufacturing Regenerative Medicine Therapies
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, research, and academic stakeholders
Event Date: 10/21/2023
Location: Washington, DC
Subject: Sino-American Pharmaceutical Professionals Association - DC (District of Columbia) Annual Conference; Speaker: Entering the Era of Human Genome Editing
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, research, and academic stakeholders
Official Name: Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health
Event Date: 10/16/2023
Location: Virtual
Subject: National Organization for Rare Disorders (NORD) Rare Diseases and Orphan Products Breakthrough Summit; Speaker: Harnessing the Power of AI: From Data to Diagnosis and Improved Outcomes
FDA Participant/Group: N/A
Non FDA Participant/Group: Members of industry, government, academia, and other stakeholders
Official Name: Donald Prater, Acting Director, Center for Food Safety and Applied Nutrition
Event Date: 10/20/2023
Location: Silver Spring, MD
Subject: Transfer of Responsibilities from Japan's Ministry of Health, Labour and Welfare (MHLW) to the Consumer Affairs Agency (CAA)
FDA Participant/Group: JULIE MOSS;
Non FDA Participant/Group: Naochiro Manago, Takahiro Nikaido, Yohko Mitchell, Yutaka Arai (Japan's Consumer Affairs Agency (CAA));
Official Name: Brian King, Ph.D., Director, Center for Tobacco Products
Event Date: 10/20/2023
Location: Washington, DC
Subject: American Academy of Pediatrics (AAP) Section on Nicotine and Tobacco Prevention and Treatment Executive Committee Meeting; CTP Update
FDA Participant/Group: N/A
Non FDA Participant/Group: Several representatives from the American Academy of Pediatrics (AAP) Section on Nicotine and Tobacco Prevention and Treatment Executive Committee
Official Name: Tracey H. Forfa, J.D., Director, Center for Veterinary Medicine
Event Date: 10/16/2023
Location: Rockville, MD
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: SIOBHAN DELANCEY; DAVID EDWARDS; TRISTAN COLONIUS; WILLIAM FLYNN; TIMOTHY SCHELL; JEANETTE MURPHY; CHARLOTTE CONWAY;
Non FDA Participant/Group: Caitlin Boon, Jason Ward, Jesse Cothran (Mars, Incorporated);
Event Date: 10/16/2023
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: SIOBHAN DELANCEY; TRISTAN COLONIUS; JULIANNA WITTIG; MATTHEW LOCKEED; DAVID EDWARDS; JEANETTE MURPHY; TIMOTHY SCHELL;
Non FDA Participant/Group: Constance Cullman, Leah Wilkinson, Louise Calderwood (American Feed Industry Association (AFIA));
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