Public Calendar : 09/11/2022 - 09/17/2022

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: 09/11/2022
Location: Virtual
Subject: HEVER 27
FDA Participant/Group: JACQUELINE CORRIGAN CURAY; PETER MARKS;
Non FDA Participant/Group: Government, industry, and other invited guests

Event Date: 09/13/2022
Location: Washington, DC
Subject: Medical Device Innovation Consortium Annual Public Forum
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, media, academia, and other registered attendees

Event Date: 09/15/2022
Location: Washington, DC
Subject: The Future of Health Data Summit
FDA Participant/Group: BAKUL PATEL;
Non FDA Participant/Group: Government, industry, media, academia, and other registered attendees

Event Date: 09/16/2022
Location: Boston, MA
Subject: Transcatheter Cardiovascular Therapeutics - Pain Points in Healthcare Innovation: Challenges and Opportunities
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, media, academia, and other registered attendees

Event Date: 09/16/2022
Location: Boston, MA
Subject: Roundtable on Regulatory Issues
FDA Participant/Group: N/A
Non FDA Participant/Group: Several members from the Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School

Official Name: Janet Woodcock, M.D., Principal Deputy Commissioner

Event Date: 09/13/2022
Location: Virtual
Subject: Introductory Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Judea Pearl (University of California, Los Angeles (UCLA)); Robert Goldberg (Center for Medicine in the Public Interest);

Event Date: 09/13/2022
Location: Silver Spring, MD
Subject: I-Spy 2.2 (Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer)
FDA Participant/Group: N/A
Non FDA Participant/Group: Laura Esserman (University of San Francisco California);

Event Date: 09/14/2022
Location: Virtual
Subject: Drug-Disease Matching Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Multiple participants

Event Date: 09/14/2022
Location: Virtual
Subject: Food Industry Association (FMI) Leadership Meeting
FDA Participant/Group: SUSAN MAYNE; FRANK YIANNAS;
Non FDA Participant/Group: Multiple participants

Event Date: 09/15/2022
Location: Silver Spring, MD
Subject: FDA Leadership Priorities
FDA Participant/Group: LEE COHEN; PETER REIKES; MELISSA SAFFORD;
Non FDA Participant/Group: Kerri Maloney, Margaret Anderson, Paul Baliff (Deloitte Consulting);

Official Name: Andi Lipstein Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs

Event Date: 09/13/2022
Location: Brussels, Belgium
Subject: Regulatory Cooperation on Medical Products and Foods Areas
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: John Ryan, Claire Bury, and their team (European Commission, Health and Food Safety)

Event Date: 09/13/2022
Location: Brussels, Belgium
Subject: Patient Engagement
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Marco Greco (remotely), Anca Toma, and their team (European Patients Forum)

Event Date: 09/13/2022
Location: Brussels, Belgium
Subject: Regulation of Pharmaceuticals and European Union Legislative Developments
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Nathalie Moll and team (European Federation of Pharmaceutical Industries and Associations (EFPIA)

Event Date: 09/13/2022
Location: Brussels, Belgium
Subject: European Union Medical Products and Foods Legislative Priorities
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Edita Hrdá and staff (Czech Presidency of the Council of the European Union)

Event Date: 09/14/2022
Location: Paris, France
Subject: Supply Chain Resilience and Health Misinformation
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: French National Agency for the Safety of Medicines and Health Products, ANSM Members

Event Date: 09/14/2022
Location: Paris, France
Subject: Whole-of-Government Approach to Combat Illicit Trade in Health Products
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Elsa Pilichowski (Organisation for Economic Co-operation and Development (OECD)

Event Date: 09/15/2022
Location: Paris, France
Subject: Whole-of-Government Approach to Combat Illicit Trade in Health Products
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: About 110 global stakeholders from government agencies, public and private sectors, and multilateral organizations

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

Official Name: Frank Yiannas, Deputy Commissioner for Food Policy and Response

No Significant Event

Official Name: Mark Abdoo, Associate Commissioner for Global Policy and Strategy

No Significant Event

Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs

Event Date: 09/13/2022
Location: Virtual
Subject: 2022 Parenteral Drug Association (PDA) / FDA Joint Regulatory Conference; ORA Updates
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several representatives from Regulatory Compliance Associates Inc.

Official Name: Erica Jefferson, 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

No Significant Event

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

Event Date: 09/12/2022
Location: Virtual
Subject: COVID-19 Boosters are Critical to Everyone - National Coalition of 100 Black Women Public Education Series; Where We Are Now With Vaccines and Treatment Options
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of COVID-19 Boosters are Critical for Everyone - National Coalition of 100 Black Women Public Education Series

Event Date: 09/12/2022
Location: Washington, DC
Subject: 2022 Parenteral Drug Association (PDA) / FDA Joint Regulatory Conference; Looking to the Future
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of 2022 Parenteral Drug Association (PDA) / FDA Joint Regulatory Conference

Event Date: 09/12/2022
Location: Washington, DC
Subject: 2022 Parenteral Drug Association (PDA) / FDA Joint Regulatory Conference; Emerging From COVID: An FDA Perspective
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of 2022 Parenteral Drug Association (PDA) / FDA Joint Regulatory Conference

Event Date: 09/12/2022
Location: Virtual
Subject: Regulatory Affairs Professionals Society 2022 Convergence; Vaccine Regulatory Pathways - Future Forward: Conversations That Matter (Drugs, Biologics and Combination Products)
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of Regulatory Affairs Professionals Society 2022 Convergence

Event Date: 09/13/2022
Location: Washington, DC
Subject: 2022 Parenteral Drug Association (PDA) / FDA Joint Regulatory Conference; CBER Updates
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of 2022 Parenteral Drug Association (PDA) / FDA Joint Regulatory Conference

Event Date: 09/13/2022
Location: Virtual
Subject: Regulatory Affairs Professionals Society 2022 Convergence; Health Authority Forum - CBER / CDER
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of Regulatory Affairs Professionals Society 2022 Convergence

Event Date: 09/14/2022
Location: Virtual
Subject: Plasma Protein Therapeutics Association / FDA Liaison Meeting; Brief Industry Update: CBER Engagement / Reorganization
FDA Participant/Group: MELISSA MENDOZA; ANNE EDER; SHERYL LARD WHITEFORD; DIANE MALONEY; CELIA SILVERMAN; NICOLE VERDUN;
Non FDA Participant/Group: Attendees of Plasma Protein Therapeutics Association / FDA Liaison Meeting

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

Event Date: 09/16/2022
Location: Virtual
Subject: Alaris Infusion Pump
FDA Participant/Group: COURTNEY LIAS; WILLIAM MAISEL; KEISHA THOMAS; MARK ANTONINO; JAKE LINDSTROM;
Non FDA Participant/Group: Ami Simunovich, Mark O'Donnell, Tom Polen (Becton, Dickinson and Company);

Official Name: Susan T. Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition

No Significant Event

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

Event Date: 09/12/2022
Location: Virtual
Subject: Introductory Meeting
FDA Participant/Group: MEGAN HICKS; BRIAN KING; ESHAEL JOHNSON;
Non FDA Participant/Group: Ranti Fayokun, Vinayak Prasad (World Health Organization (WHO) No Tobacco Unit (TFI));

Event Date: 09/13/2022
Location: Virtual
Subject: Introductory Leadership Meeting
FDA Participant/Group: ESHAEL JOHNSON; TODD CECIL; KARIN RUDOLPH; ANH ZARNDT; BRIAN KING; BENJAMIN APELBERG; MICHELE MITAL; DANA VAN BEMMEL; PRISCILLA LYON;
Non FDA Participant/Group: Representatives of Society for Research on Nicotine and Tobacco

Official Name: Steven Solomon, Director, Center for Veterinary Medicine

Event Date: 09/13/2022
Location: Washington, DC
Subject: 2022 Parenteral Drug Association (PDA) / FDA Joint Regulatory Conference; CVM Updates
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of 2022 Parenteral Drug Association (PDA) / FDA Joint Regulatory Conference

Official Name: Tucker Patterson, Ph.D., Acting Director, National Center for Toxicological Research

Event Date: 09/11/2022
Location: Cluj, Romania
Subject: International Congress on Neuroprotective Agents (ICNA) Presentation; Methods for Neurotoxicity Assessments
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, government, and academia

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

No Significant Event