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  5. Public Calendar for the week of 11/17/2024 - 11/23/2024
  1. Public Calendar - Meetings With FDA Officials

Public Calendar for the week of 11/17/2024 - 11/23/2024

Public Calendar : 11/17/2024 - 11/23/2024

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: 11/18/2024
Location: Silver Spring, MD
Subject: FDA Bridging Gaps in Women's Health: A Roundtable on Medical Product Development for Women
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Lucy Vereshchagina (Pharmaceutical Research and Manufacturers of America); Ana Loloei, Diedre Washington (Advanced Medical Technology Association); Derek Scholes (Biotechnology Innovation Organization);

Event Date: 11/19/2024
Location: Virtual
Subject: FDA 2024 One Health Symposium; Speaker: Opening Remarks
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, government, and other registered attendees

Event Date: 11/19/2024
Location: Virtual
Subject: University of Chicago, Data for the Common Good - Advancing Data Collaboration in Rare Disease and Epilepsy Research; Speaker: Rare Disease Drug Development
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other registered attendees

Event Date: 11/20/2024
Location: Gaithersburg, MD
Subject: FDA's Digital Health Advisory Commitee Meeting: Generative AI in Digital Health Technologies (DHTs)
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, media, and other registered attendees

Event Date: 11/21/2024
Location: Virtual
Subject: The National Academies of Science, Engineering, and Medicine Committee on Strategies to Better Align Investments in Innovations for Therapeutic Development with Disease Burden and Unmet Needs
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, media, and other registered attendees

Official Name: Namandjé N. Bumpus, Ph.D., Principal Deputy Commissioner

No Significant Event

Official Name: Jim Jones, Deputy Commissioner for Human Foods

Event Date: 11/18/2024
Location: College Park, MD
Subject: Food Traceability
FDA Participant/Group: CATHERINE MCDERMOTT; ANGELA FIELDS; CHRISTOPHER WALDROP; DONALD PRATER; LAUREN FINNEGAN;
Non FDA Participant/Group: Angela Fernandez, Bob Carpenter, Maggie Lyons (GS1 US);

Event Date: 11/19/2024
Location: Washington, DC
Subject: Nutrition Issues of Mutual Interest
FDA Participant/Group: ERIN WHITE; ERIC CROSBY; KRISTINE BUTLER;
Non FDA Participant/Group: Several staff and students from the DC Bilingual Public Charter School

Event Date: 11/19/2024
Location: Virtual
Subject: Food Chemical Safety
FDA Participant/Group: JESSICA ROWDEN; ELISABETH DAVIS; KIRSTEN BYERTS; KRISTI MULDOON JACOBS;
Non FDA Participant/Group: Staff and members of the National Conference of State Legislatures

Event Date: 11/21/2024
Location: Washington, DC
Subject: Human Foods Program Priorities
FDA Participant/Group: JANESIA ROBBS; DAVID ARVELO;
Non FDA Participant/Group: Staff and members of the National Association of Manufacturers

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: Michael Rogers, Associate Commissioner for Inspections and Investigations

No Significant Event

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

Event Date: 11/20/2024
Location: Silver Spring, MD
Subject: Over-The-Counter Monograph Drug User Fee Program (OMUFA) Reauthorization 2024 Public Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Dan Selechnik (Fragrance Creators Association); Meredith Petillo (Independent Beauty Association); Gil Roth (Pharma and Biopharma Outsourcing Association); Eric P. Brass (University of California, Los Angeles (UCLA)); Emily Manoso (Personal Care Products Council); Diana Zuckerman (National Center for Health Research); Mike Bailey (Consumer Healthcare Products Association); James Kim (American Cleaning Institute);

Event Date: 11/22/2024
Location: Virtual
Subject: Rare Disease Innovation Hub - Real World Evidence Subcommittee Listening Session
FDA Participant/Group: N/A
Non FDA Participant/Group: Several Cystic Fibrosis Foundation (CFF) representatives

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

Event Date: 11/18/2024
Location: Virtual
Subject: Indo - U.S. Bridging RARE Summit 2024; Keynote: Recent FDA Regulatory Progress and Perspectives on Cell and Gene Therapies
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, government, media, and other registered attendees

Event Date: 11/19/2024
Location: Virtual
Subject: International Society for Cell and Gene Therapy/FDA Liaison Meeting
FDA Participant/Group: IBILOLA FASHOYIN-AJE; CHRISTOPHER JONECKIS; MELISSA MENDOZA; STEVEN OH; HEATHER LOMBARDI; NICOLE VERDUN; CELIA SILVERMAN; RACHAEL ANATOL;
Non FDA Participant/Group: Industry and government

Event Date: 11/20/2024
Location: Bethesda, MD
Subject: Alliance for Regenerative Medicine's FDA Scientific Exchange 2024; Speaker: Advancing Gene Editing Platforms for Rare Diseases
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, government, media, and other stakeholders

Event Date: 11/20/2024
Location: Virtual
Subject: Biomanufacturing World Summit 2024; Speaker: Accelerating the Pace of Progress for Innovative Biologic Products
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, government, media, and other registered attendees

Event Date: 11/20/2024
Location: Washington, DC
Subject: Pediatric Rheumatology Collaborative Study Group Advisory Council Meeting; Speaker: CAR T Cell Products CAR T/NK Cell Therapy - Regulatory Landscape
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, government, media, and other registered attendees

Official Name: Michelle Tarver, M.D., Ph.D., Director, Center for Devices and Radiological Health

Event Date: 11/18/2024
Location: Virtual
Subject: General Medical Device Updates
FDA Participant/Group: ELIZABETH HILLEBRENNER; BRITTANY SCHUCK;
Non FDA Participant/Group: Dave Kuldip, Keith Gary, Lisa Law, Rich Brennan (Amyotrophic Lateral Sclerosis (ALS) Association);

Event Date: 11/20/2024
Location: Gaithersburg, MD
Subject: Digital Health Advisory Committee (DHAC); Speaker: Opening Remarks
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry and federal regulatory

Event Date: 11/21/2024
Location: Silver Spring, MD
Subject: General Medical Device and Robotic Updates
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several Medtronic representatives

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

No Significant Event

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

Event Date: 11/21/2024
Location: Virtual
Subject: Animal Health Institute (AHI) Board Meeting
FDA Participant/Group: TRISTAN COLONIUS; WILLIAM FLYNN;
Non FDA Participant/Group: Several Animal Health Institute (AHI) representatives

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

No Significant Event

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