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  5. Public Calendar: April 21-27, 2024
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: April 21-27, 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: 04/22/2024
Location: Silver Spring, MD
Subject: PDUFA VII Implementation Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: James Stansel, Kelly Goldberg, Kristy Lupejkis, Lucy Vereshchagina, Stephen J. Ubl (PhRMA); Cartier Esham, John Crowley (BIO); Richard Pops (Alkermes); Sebastian Guth (Bayer U.S.); Mike Raab (Ardelyx);

Event Date: 04/24/2024
Location: Boston, MA
Subject: World Orphan Drug Congress USA - Charting the Path Forward: Regulatory Innovations and Orphan Drug Designations in Rare Disease Development
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, government, media, academia, and other registered attendees

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

Event Date: 04/24/2024
Location: Silver Spring, MD
Subject: FDA and European Commission/European Food Safety Authority/European Medicines Agency Bilateral Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several European Union representatives

Official Name: Jim Jones, Deputy Commissioner for Human Foods

Event Date: 04/22/2024
Location: College Park, MD
Subject: Food Chemical Safety Issues of Mutual Interest
FDA Participant/Group: KRISTI MULDOON JACOBS; JESSICA ROWDEN; STEVEN MUSSER;
Non FDA Participant/Group: Melanie Benesh, Scott Faber (Environmental Working Group); Brian Ronholm, Michael Hansen (Consumer Reports); Maria Doa, Maricel Maffini (Environmental Defense Fund);

Event Date: 04/22/2024
Location: College Park, MD
Subject: Human Foods Program Update
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members from consumer and public health organizations

Event Date: 04/23/2024
Location: Silver Spring, MD
Subject: Food and Chemical Safety Issues of Mutual Interest
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members from consumer and public health organizations

Event Date: 04/25/2024
Location: Washington, DC
Subject: Nutrition Issues of Mutual Interest
FDA Participant/Group: N/A
Non FDA Participant/Group: Members of the Committee on Nutrition, American Academy of Pediatrics

Event Date: 04/25/2024
Location: College Park, MD
Subject: Front-of-Package Labeling and the Term "Healthy" on Food Labeling
FDA Participant/Group: ROBIN MCKINNON; LAURA CARROLL; JANESIA ROBBS; MARIANNA NAUM;
Non FDA Participant/Group: Jennifer Gardner (Ahold Delhaize); Julie Greene (Guiding Stars Licensing Company); Beth Johnson (Food Directions);

Event Date: 04/25/2024
Location: Virtual
Subject: Updates on Highly Pathogenic Avian Influenza
FDA Participant/Group: N/A
Non FDA Participant/Group: Several attendees from across the dairy industry, academia, state and federal governments

Official Name: Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs

Event Date: 04/25/2024
Location: Silver Spring, MD
Subject: Leadership Dialogue on Medical Products; Moderated “Fireside Chat”
FDA Participant/Group: HILARY MARSTON;
Non FDA Participant/Group: Marco Marsella (European Commission); Steffen Thirstrup (European Medicines Agency);

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, Associate Commissioner for Regulatory Affairs

No Significant Event

Official Name: Leah Hunter, Associate Commissioner for External Affairs

No Significant Event

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

Event Date: 04/25/2024
Location: Virtual
Subject: Quantitative Medicine Center of Excellence Workshop; Opening Remarks
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, regulatory, and other stakeholders

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

Event Date: 04/23/2024
Location: Virtual
Subject: Advanced Therapy Medicinal Products (ATMP) Global World Tour 2024; Accelerating the Pace of Progress for ATMPs
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the Advanced Therapy Medicinal Products Global World Tour 2024

Event Date: 04/23/2024
Location: Virtual
Subject: Alliance for a Stronger FDA Webinar; CBER FY 2025 Budget Priorities
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the Alliance for a Stronger FDA Webinar

Event Date: 04/24/2024
Location: Boston, MA
Subject: World Orphan Drug Congress USA 2024; Expediting Drug Development for Rare Disease; Challenge and Opportunity with the Current Regulatory and Legislative Landscape in the U.S.
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the World Orphan Drug Congress USA 2024

Event Date: 04/25/2024
Location: Baltimore, MD
Subject: Maryland Stem Cell and Regenerative Medicine Tech Showcase; Advancing Development of Stem Cell and Regenerative Medicine Therapies
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the Maryland Stem Cell and Regenerative Medicine Tech Showcase

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

Event Date: 04/24/2024
Location: Virtual
Subject: MedCon Conference: Returning to the New Normal in the Face of Evolving Challenges; Update from CDRH Director
FDA Participant/Group: Several FDA staff
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: 04/24/2024
Location: Virtual
Subject: National Assembly of State Animal Health Officials (NASAHO) Update on Emerging Animal Health Event in Dairy Cattle
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives from National State Departments of Agriculture (NASDA), National Assembly of State Animal Health Officials (NASAHO), U.S. Dept of Agriculture, and Centers for Disease Control

Event Date: 04/25/2024
Location: Virtual
Subject: National Conference on Interstate Milk Shipments (NCIMS) Executive Board Meeting on Highly Pathogenic Avian Influenzas
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several NCIMS officials

Event Date: 04/26/2024
Location: Virtual
Subject: World Health Organization (WHO) on Link Up
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several representatives of WHO

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

Event Date: 04/22/2024
Location: Utrecht, Netherlands
Subject: Global Tobacco Regulators Forum (GTRF) Annual Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Representatives of the World Health Organization's Global Tobacco Regulators Forum (GTRF)

Event Date: 04/23/2024
Location: Virtual
Subject: Tobacco Merchants Association (TMA) Annual Conference; Keynote Address: FDA Center for Tobacco Products' 5-Year Strategic Plan
FDA Participant/Group: N/A
Non FDA Participant/Group: Several representatives of the Tobacco Merchants Association (TMA) and conference attendees

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

Event Date: 04/22/2024
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives of the National Association of State Departments of Agriculture (NASDA)

Event Date: 04/23/2024
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: DAVID EDWARDS; WILLIAM FLYNN; JEANETTE MURPHY; TIMOTHY SCHELL; CHARLOTTE CONWAY;
Non FDA Participant/Group: Atalie Ebersole, Betsy Flores, Dana Brooks, Patrick Tovey (Pet Food Industry);

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

 

 
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