Public Calendar: May 15-21, 2022
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 of Food and Drugs
Event Date: 05/15/2022
Location: Virtual
Subject: Infant Formula Issues
FDA Participant/Group: PERHAM GORJI; JULIA TIERNEY; MARK RAZA;
Non FDA Participant/Group: Hubert Allen, Robert Ford, Thomas Evers (Abbott Laboratories);
Event Date: 05/16/2022
Location: Boston, MA
Subject: American Association for Thoracic Surgery 102nd Annual Meeting; Speaker: The Role of the FDA in Facilitating Cardiovascular Innovation
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, academia, and other invited guests
Event Date: 05/16/2022
Location: Virtual
Subject: Pharmacokinetic Evaluation in Pregnancy Public Workshop; Speaker: Keynote Address
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, academia, media, and other registered guests
Event Date: 05/16/2022
Location: Virtual
Subject: Reagan-Udall Foundation for the FDA Annual Public Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, academia, media, and other invited guests
Event Date: 05/17/2022
Location: Virtual
Subject: Society for Clinical Trials 43rd Annual Meeting; Speaker: The Time is Now to Fix the Evidence Generation System
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, academia, media, and other registered guests
Event Date: 05/18/2022
Location: Virtual
Subject: Infant Formula Issues
FDA Participant/Group: JULIA TIERNEY; TRISTAN COLONIUS; FRANK YIANNAS;
Non FDA Participant/Group: Brent Cox, Howard Popoola, Karen McGuire, Keith Dailey, William McMullen (Kroger);
Event Date: 05/19/2022
Location: Virtual
Subject: Infant Formula Issues
FDA Participant/Group: FRANK YIANNAS; TRISTAN COLONIUS; JULIA TIERNEY;
Non FDA Participant/Group: Claire Babineaux-Fontenot, Kathryn Strickland, Vince Hall (Feeding America);
Event Date: 05/19/2022
Location: Virtual
Subject: Infant Formula Issues
FDA Participant/Group: TRISTAN COLONIUS; FRANK YIANNAS; JULIA TIERNEY;
Non FDA Participant/Group: Molly Fogarty, Steven Presley (Nestle USA);
Event Date: 05/19/2022
Location: Virtual
Subject: Infant Formula Issues
FDA Participant/Group: JULIA TIERNEY; TRISTAN COLONIUS; FRANK YIANNAS;
Non FDA Participant/Group: Allison Solley, Andrew Harris, Douglas Herrington (Amazon);
Event Date: 05/20/2022
Location: Virtual
Subject: Infant Formula Issues
FDA Participant/Group: FRANK YIANNAS; JULIA TIERNEY; TRISTAN COLONIUS;
Non FDA Participant/Group: Brian Kineman, Christopher Adamo, Marie Kalil, Nancy Dowling, Romina Fernandez, Shane Grant (Danone North America); Anne Laraway (Happy Family Brands); Miguel Del Toro (Nutricia);
Event Date: 05/20/2022
Location: Virtual
Subject: Infant Formula Issues
FDA Participant/Group: TRISTAN COLONIUS; JULIA TIERNEY; FRANK YIANNAS;
Non FDA Participant/Group: Alexandre Biella, Arthur Pike, Geoffroy Ribadeau-Dumas, Justin Griner, Robert Cleveland (Reckitt);
Event Date: 05/20/2022
Location: Virtual
Subject: Infant Formula Issues
FDA Participant/Group: FRANK YIANNAS; PETER BECKERMAN; PERHAM GORJI; JULIA TIERNEY; TRISTAN COLONIUS;
Non FDA Participant/Group: Hubert Allen, Robert Ford, Thomas Evers (Abbott Laboratories);
Official Name: Janet Woodcock, M.D., Principal Deputy Commissioner
Event Date: 05/17/2022
Location: Virtual
Subject: Good Clinical Trials Collaborative Steering Group Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Participants interested in developing guidance to enable and promote informative, ethical and efficient Randomized Controlled Clinical Trials (RCTs)
Event Date: 05/17/2022
Location: Virtual
Subject: Researching COVID to Enhance Recovery (RECOVER) Executive Committee Meeting
FDA Participant/Group: PETER MARKS;
Non FDA Participant/Group: RECOVER Executive Committee Members
Event Date: 05/18/2022
Location: Silver Spring, MD
Subject: Agência Nacional de Vigilância Sanitária (ANVISA) Bilateral Meeting
FDA Participant/Group: THERESA MULLIN; PETER MARKS; MARK ABDOO; MELISSA TORRES;
Non FDA Participant/Group: Antonio Barra, Karin Mendes, Leonardo Dutra, Marise Nogueira, Samia Melo (ANVISA);
Event Date: 05/18/2022
Location: Virtual
Subject: ACTIV-2/-3/-6 Trial Oversight Committee Meeting
FDA Participant/Group: PETER STEIN;
Non FDA Participant/Group: Participants interested in Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)
Event Date: 05/20/2022
Location: Dana Point, CA
Subject: Personalized Medicine Coalition’s 16th Annual Personalized Medicine Conference; Speaker: Keynote Remarks
FDA Participant/Group: N/A
Non FDA Participant/Group: Participants representing the full scope of the health care spectrum, including clinicians, industry executives, investors, patient advocates, payers, policy experts, and researchers
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: Frank Yiannas, Deputy Commissioner for Food Policy and Response
Event Date: 05/16/2022
Location: Virtual
Subject: Infant Formula Shortages
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several staff from the U.S. House and Senate Subcommittees on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Event Date: 05/17/2022
Location: Virtual
Subject: Infant Formula Shortages
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several hundred members of healthcare professional groups, consumer groups, food science groups, and food and grocery trade associations
Event Date: 05/20/2022
Location: Virtual
Subject: Infant Formula Shortages
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several staff from the U.S. Senate Committee on Health, Education, Labor and Pensions
Event Date: 05/20/2022
Location: Virtual
Subject: Infant Formula Shortages
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several staff from the U.S. House Committee on Energy and Commerce
Official Name: Mark Abdoo, Associate Commissioner for Global Policy and Strategy
No Significant Event
Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs
No Significant Event
Official Name: Erica Jefferson, Associate Commissioner for External Affairs
No Significant Event
Official Name: Jacqueline O'Shaughnessy, Acting Chief Scientist
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: 05/15/2022
Location: Virtual
Subject: American Society of Gene and Cell Therapy Pre-Meeting Workshop (A Focus on Gene and Cell Therapy): Clinical Trials and the Role of FDA: Identifying Definitive Clinical Outcomes
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia and bio-industry stakeholders
Event Date: 05/17/2022
Location: Virtual
Subject: American Society of Gene and Cell Therapy Annual Meeting; Speaker: Fireside Chat - State of the Field: Emerging Regulatory Trends
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia and bio-industry stakeholders
Event Date: 05/20/2022
Location: Virtual
Subject: Friends of Cancer Research Supporting Development of Next Generation Cellular Therapies; Panelist: Regulatory Landscape
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, industry, and patient stakeholders
Official Name: Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health
No Significant Event
Official Name: Susan T. Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition
Event Date: 05/16/2022
Location: Virtual
Subject: Food Allergy Research and Education (FARE) Meeting on Food Allergies
FDA Participant/Group: JENNIFER DOOREN;
Non FDA Participant/Group: Jason Linde, Robert Earl (Food Allergy Research & Education);
Official Name: Michele Mital, Acting Director, Center for Tobacco Products
No Significant Event
Official Name: Steven Solomon, Director, Center for Veterinary Medicine
Event Date: 05/17/2022
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: NADINE STEINBERG; WILLIAM FLYNN; NICOLE PEPPERL; ANTONIA MONIQUE SENNETT; AMBER MCCOIG;
Non FDA Participant/Group: Members of Outsourcing Facilities Association (OFA)
Event Date: 05/18/2022
Location: Arlington, VA
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: N/A
Non FDA Participant/Group: Members of Animal Feed Industry Association (AFIA)
Official Name: Tucker Patterson, Ph.D., Acting Director, National Center for Toxicological Research
Event Date: 05/18/2022
Location: Virtual
Subject: National Center for Toxicological Research (NCTR) Public Scientific Advisory Board Meeting; Speaker: Overview of NCTR
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, and other stakeholders
Official Name: Mark Raza, J.D., Chief Counsel
No Significant Event