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: 09/19/2022
Location: Silver Spring, MD
Subject: Increasing the Efficiency of Biosimilar Development Programs
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, academia, media, and other registered attendees

Event Date: 09/20/2022
Location: Washington, DC
Subject: Alliance for Aging Research: 2022 Heroes in Health: An Evening to Celebrate Generativity, Joy, and Healthy Aging
FDA Participant/Group: STACY MATHEW; JOHN GOODRICH;
Non FDA Participant/Group: Government, industry, and other invited attendees

Event Date: 09/20/2022
Location: Virtual
Subject: National Health Research Forum
FDA Participant/Group: DAYLE CRISTINZIO;
Non FDA Participant/Group: Government, industry, academia, media, and other registered attendees

Event Date: 09/20/2022
Location: Virtual
Subject: Advancing Generic Drug Development: Translating Science to Approval
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, media, and other registered attendees

Event Date: 09/20/2022
Location: Washington, DC
Subject: 2022 Samuel J. Heyman Service to America Medals
FDA Participant/Group: STEVEN MUSSER; JULIA TIERNEY;
Non FDA Participant/Group: government, industry, media, academia, and other invited attendees

Event Date: 09/20/2022
Location: Washington, DC
Subject: Bipartisan Congressional Awards Reception
FDA Participant/Group: JANET WOODCOCK;
Non FDA Participant/Group: Government, industry, media, and other invited attendees

Event Date: 09/21/2022
Location: Washington, DC
Subject: National Academy of Medicine Leadership Consortium
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, academia, and other invited attendees

Event Date: 09/22/2022
Location: Virtual
Subject: Health Connect South
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, academia, and other invited attendees

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

Event Date: 09/19/2022
Location: Virtual
Subject: Patient-Centered Outcomes Research Institute (PCORI) Board of Governers Sessions
FDA Participant/Group: N/A
Non FDA Participant/Group: Several PCORI Board Members

Event Date: 09/21/2022
Location: Washington, DC
Subject: Clinical Trials Transformation Initiative: Embedding Clinical Trials Into Clinical Practice
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, academia, and other invited attendees

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: 09/20/2022
Location: Virtual
Subject: New Era of Smarter Food Safety Topics of Mutual Interest
FDA Participant/Group: N/A
Non FDA Participant/Group: Ruth Petran (University of Minnesota);

Event Date: 09/20/2022
Location: Virtual
Subject: Food Safety Magazine Webinar; Evolution of a New Era: Advancing Strategies for Smarter Food Safety
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, and government

Event Date: 09/23/2022
Location: Virtual
Subject: Infant Formula Issues of Mutual Interest
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, trade, and retail associations

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: 09/21/2022
Location: Silver Spring, MD
Subject: Signing Ceremony for Memorandum of Understanding
FDA Participant/Group: ABRAM BROWN; SUSAN MAYNE;
Non FDA Participant/Group: Patrick Breysse (CDC);

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: 09/19/2022
Location: Virtual
Subject: National Foundation for Infectious Diseases: COVID-19 Updates: Current Booster Recommendations
FDA Participant/Group: N/A
Non FDA Participant/Group: Healthcare professionals, academia, and patient stakeholders

Event Date: 09/20/2022
Location: Virtual
Subject: Cell and Gene Therapy USA 2022; Panelist: Scale at Speed - Pinpoint the Impact Accelerated Approvals Will Have on Your Commercial Planning
FDA Participant/Group: N/A
Non FDA Participant/Group: Healthcare professionals, industry, and patient stakeholders

Event Date: 09/20/2022
Location: Virtual
Subject: Cell and Gene Therapy USA 2022; FDA Insights: Understanding the Different Approval Pathways
FDA Participant/Group: N/A
Non FDA Participant/Group: Healthcare professionals, industry, and patient stakeholders

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

Event Date: 09/19/2022
Location: Silver Spring, MD
Subject: General Medical Device
FDA Participant/Group: MELISSA TORRES;
Non FDA Participant/Group: John Skerritt (Australian Department of Health);

Event Date: 09/20/2022
Location: Bethesda, MD
Subject: Consumer Healthcare Products Association's Regulatory, Scientific, and Quality Conference: CDRH Leadership Update
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry

Event Date: 09/23/2022
Location: Virtual
Subject: Final Rule on Hearing Aids and Related Amendments
FDA Participant/Group: SIYEON LEE; ANGELA KRUEGER; ARIEL SEELEY; JULIE COHEN; ERIC MANN; IAN OSTERMILLER; JASON SULLIVAN; SRINIVAS NANDKUMAR;
Non FDA Participant/Group: Members of the Hearing Loss Association of America

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: 09/19/2022
Location: Virtual
Subject: Cigar Rights of America (CRA) Listening Session on Regulatory History and Status and Future Regulatory Issues
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives of Cigar Rights of America (CRA)

Event Date: 09/20/2022
Location: Virtual
Subject: Introductory Meeting with Australian Therapeutic Goods Administration (TGA)
FDA Participant/Group: MEGAN HICKS; MICHELE MITAL; BRIAN KING;
Non FDA Participant/Group: John Skerritt (Australian Therapeutic Goods Administration (TGA));

Event Date: 09/20/2022
Location: Virtual
Subject: Follow-Up Meeting on Regulation and Enforcement of Non-Tobacco Nicotine and Premarket Tobacco Product Applications
FDA Participant/Group: KIMBERLEE TRZECIAK; MICHELE MITAL; BRIAN KING;
Non FDA Participant/Group: Jessica McNiece (Office of Senator Dick Durbin (D-IL));

Event Date: 09/23/2022
Location: Virtual
Subject: Introductory Meeting with NJOY, LLC
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: David Graham, Jeff Weiss, Ryan Nivakoff (NJOY, LLC);

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

Event Date: 09/23/2022
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: TIMOTHY SCHELL; ANNE NORRIS; TRACEY FORFA;
Non FDA Participant/Group: Representatives of Truth about Pet Food

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

Event Date: 09/18/2022
Location: Maastricht, Netherlands
Subject: International Congress of Toxicology Conference; Panelist
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Academia, industry, and other foreign government officials

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

No Significant Event