Public Calendar for the week of 12/08/2024 - 12/14/2024
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: 12/08/2024
Location: Washington, DC
Subject: Cardiovascular Clinical Trialists Workshop; Moderator: JAMA's New Guidance on Nonrandomized Evidence
FDA Participant/Group: BRAM ZUCKERMAN; ANDREW FARB; NORMAN STOCKBRIDGE;
Non FDA Participant/Group: Industry and other invited guests
Event Date: 12/09/2024
Location: Washington, DC
Subject: 21st Global Cardiovascular Clinical Trialists Forum; Chairperson: Real World Data (RWD) What It Is, Why It's Useful and Why Cardiologists Should Care?
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Academia, industry, government, media, and other registered attendees
Event Date: 12/09/2024
Location: Washington, DC
Subject: Cardiovascular Clinical Trialists Forum Speaker's Cocktail Reception
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Academia, industry, government, and other invited guests
Event Date: 12/09/2024
Location: Washington, DC
Subject: Robert Wood Johnson Foundation Health Policy Fellows and National Academy of Medicine Distinguished Nurse Scholar-In-Residence Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Several fellows and staff of the Robert Wood Johnson Foundation and staff from the National Academy of Medicine
Event Date: 12/10/2024
Location: Silver Spring, MD
Subject: FDA's Building Public Trust Communicators Symposium; Opening Remarks
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry
Event Date: 12/10/2024
Location: Virtual
Subject: Reagan-Udall Foundation for the FDA Board of Directors Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Several board members and staff from Reagan-Udall Foundation
Event Date: 12/10/2024
Location: Washington, DC
Subject: Innovations in Regulatory Science Awards Dinner
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, government, academia, media, and other invited guests
Event Date: 12/11/2024
Location: Washington, DC
Subject: 21st Global Cardiovascular Clinical Trialists Forum; Chairperson: How to Promote Inclusiveness and Accelerate Approval of Evidence Based Cardiovascular Therapy Globally
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Academia, industry, government, media, and other registered attendees
Event Date: 12/11/2024
Location: Virtual
Subject: 2024 RareVoice Lifetime Achievement Award Ceremony
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, industry, government, media, and other invited guests
Event Date: 12/12/2024
Location: Sacramento, CA
Subject: California Bird Flu
FDA Participant/Group: STEVEN GRUBE; JAMES JONES;
Non FDA Participant/Group: Kim Johnson (California Health and Human Services); Annette Jones, Erica Pan, Karen Ross (California Department of Agriculture); Nirav Shah (Centers for Disease Control);
Event Date: 12/12/2024
Location: Lodi, CA
Subject: California Farm to School Grant Program
FDA Participant/Group: JAMES JONES; STEVEN GRUBE;
Non FDA Participant/Group: Several California government employees, students and faculty from Lodi Unified School District, and other invited guests
Event Date: 12/12/2024
Location: Turlock, CA
Subject: Advancing Lab Capabilities
FDA Participant/Group: STEVEN GRUBE; JAMES JONES;
Non FDA Participant/Group: Diana Tibor (Department of General Services); Annette Jones, Karen Ross (California Department of Agriculture); Nirav Shah (Centers for Disease Control); Stephen Beam (California Department of Food and Agriculture);
Event Date: 12/12/2024
Location: Virtual
Subject: Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products Public Workshop
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, academia, media, and other registered guests
Event Date: 12/12/2024
Location: Virtual
Subject: Association of Clinical Research Organization Annual Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry and other invited guests
Event Date: 12/13/2024
Location: Virtual
Subject: Beyond the Scale Obesity Summit
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, academia, media, and other registered attendees
Event Date: 12/13/2024
Location: Hilmar, CA
Subject: California Bird Flu
FDA Participant/Group: STEVEN GRUBE; JAMES JONES;
Non FDA Participant/Group: Several Hilmar Cheese employees, local dairy and poultry producers, government and other invited attendees
Official Name: Namandjé N. Bumpus, Ph.D., Principal Deputy Commissioner
Event Date: 12/10/2024
Location: Silver Spring, MD
Subject: FDA's Building Public Trust Symposium; Networking with FDA Principals
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry
Official Name: Jim Jones, Deputy Commissioner for Human Foods
No Significant Event
Official Name: Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs
Event Date: 12/11/2024
Location: Washington, DC
Subject: Pharmaceutical Care Mangement Association (PCMA) Holiday Party
FDA Participant/Group: KIMBERLEE TRZECIAK;
Non FDA Participant/Group: Widely attended gathering
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
No Significant Event
Official Name: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
Event Date: 12/09/2024
Location: Virtual
Subject: RegenBio Summit-Transforming Next-Gen Biotherapeutics 2024; Fireside Chat: Mistakes and Lessons Learned from FDA CBER Director's Desk, An Insight Into Accelerated Approval Pathways
FDA Participant/Group: N/A
Non FDA Participant/Group: Research and healthcare stakeholders
Event Date: 12/09/2024
Location: Virtual
Subject: RegenBio Summit-Transforming Next-Gen Biotherapeutics 2024; Speaker: Regulating Regenerative Therapies From IND (Investigational New Drug Application) to BLA (Biologics License Application)
FDA Participant/Group: N/A
Non FDA Participant/Group: Research and healthcare stakeholders
Official Name: Michelle Tarver, M.D., Ph.D., Director, Center for Devices and Radiological Health
Event Date: 12/09/2024
Location: Silver Spring, MD
Subject: General Medical Device Updates
FDA Participant/Group: ROSS SEGAN; JESSICA PAULSEN; ROBERT OCHS; TROY TAZBAZ; SONJA FULMER;
Non FDA Participant/Group: Laila Gurney, Peter Arduini, Taha Kass-Hout (GE Healthcare);
Event Date: 12/09/2024
Location: Virtual
Subject: General Medical Device Updates
FDA Participant/Group: KEISHA THOMAS; DANIEL DWYER; KATHARINE SEGARS; DON CALOGERO; DANIEL WALTER; KATELYN BITTLEMAN; ELAINE MAYHALL; EMILY STRUNK; RYAN ORTEGA;
Non FDA Participant/Group: Scott Haber (American Academy of Ophthalmology); Michael Repka (Johns Hopkins Medicine); Mark Cribben (American Society of Cataract and Refractive Surgery);
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
No Significant Event
Official Name: Mark Raza, J.D., Chief Counsel
No Significant Event