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  5. Public Calendar: December 12-18, 2021
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: December 12-18, 2021

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: Janet Woodcock, M.D., Acting Commissioner

Event Date: 12/14/2021
Location: Virtual
Subject: Reagan-Udall Foundation Innovations in Regulatory Science Awards
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, academia, media, and other invited guests

Event Date: 12/15/2021
Location: Virtual
Subject: Trial Updates and Protocols
FDA Participant/Group: PETER STEIN;
Non FDA Participant/Group: Parties involved in Accelerating COVID-19 Therapeutic Interventions and Vaccines

Event Date: 12/16/2021
Location: Virtual
Subject: 8th Annual Bill and Melinda Gates Foundation/National Institutes of Health Workshop
FDA Participant/Group: PETER MARKS;
Non FDA Participant/Group: Government and members of the Bill and Melinda Gates Foundation

Event Date: 12/17/2021
Location: Virtual
Subject: 6th Food Allergy Fund Summit
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, academia, media, and other registered guests

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: 12/14/2021
Location: Virtual
Subject: Food Bev Horizons U.S. Summit; Keynote: FDA Update
FDA Participant/Group: N/A
Non FDA Participant/Group: North American food and beverage manufacturers and regulators

Event Date: 12/15/2021
Location: Virtual
Subject: FDA Proposed Changes to Agricultural Water Requirements in the Produce Safety Rule
FDA Participant/Group: CHELSEA DAVIDSON; CHARLOTTE CHRISTIN; SAMIR ASSAR; MAHLET GOITOM;
Non FDA Participant/Group: Several staff members from the U.S. Senate Committee on Health, Education, Labor and Pensions

Event Date: 12/15/2021
Location: Virtual
Subject: FDA Proposed Changes to Agricultural Water Requirements in the Produce Safety Rule
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members and staff from the National Association of State Departments of Agriculture

Event Date: 12/16/2021
Location: Virtual
Subject: Food Safety Issues of Mutual Interest; Quarterly Meeting with the Food and Beverage Issues Alliance
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members from the Food and Beverage Issue Alliance

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

Event Date: 12/16/2021
Location: Virtual
Subject: iPLEDGE Risk Evaluation and Mitigation Strategies (REMS) Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives from Health and Human Services (HHS), American Academy of Dermatology Association (AADA), National Chain Drug Stores (NACDS), isotrentinoin manufacturers and vendors

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

Event Date: 12/13/2021
Location: Virtual
Subject: Alliance for Regenerative Medicine / FDA Liaison Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives from the Alliance for Regenerative Medicine

Event Date: 12/13/2021
Location: Virtual
Subject: Gene Editing and Real-World Data - A New Generation for Real-World Evidence: Opportunities for Use of Real-World Evidence to Support Regulatory Decision Making
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the American Society of Hematology Annual Meeting and Exposition

Event Date: 12/15/2021
Location: Virtual
Subject: Keynote: Facilitating the Development of COVID-19 Vaccines; Panelist: Lessons Learned from COVID-19 and How to Prepare for the Future
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the BioMAN (biomanufacturing) Consortium 2021 Vaccines Bioprocess Development & Commercialization Workshop

Event Date: 12/16/2021
Location: Virtual
Subject: Keynote: Advancing the Development of Cell and Gene Therapies
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the Massachusetts Institute of Technology / Center for Biomedical Innovation BioMAN (Biomanufacturing) Summit: Technologies to Expand the Reach of Cell and Gene Therapies

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

No Significant Event

Official Name: Mitchell R. Zeller, J.D., Director, Center for Tobacco Products

No Significant Event

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

Event Date: 12/17/2021
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: AMBER MCCOIG; WILLIAM FLYNN; CINDY BURNSTEEL; TIMOTHY SCHELL; ANTONIA MONIQUE SENNETT; NADINE STEINBERG; SIOBHAN DELANCEY; ASHLEY STEEL; MATTHEW LUCIA; NEAL BATALLER; PATRICK MCDERMOTT; SHANNON RUTHERFORD;
Non FDA Participant/Group: Representatives of The Pew Charitable Trusts

Official Name: William Slikker, Jr., 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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