Public Calendar for the week of December 4 - December 10, 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: 12/05/2022
Location: Silver Spring, MD
Subject: Prescription Drug User Fee Act VII Implementation Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members and staff of the Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization

Event Date: 12/05/2022
Location: Virtual
Subject: FDA Digital Transformation Symposium
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, and other registered attendees

Event Date: 12/06/2022
Location: Virtual
Subject: Independent Panel of Experts Report on FDA's Food Program Meeting
FDA Participant/Group: TRISTAN COLONIUS;
Non FDA Participant/Group: Mike Taylor (STOP Foodborne Illness);

Event Date: 12/06/2022
Location: Washington, DC
Subject: Innovations in Regulatory Science Awards Dinner
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, academia, Regan Udall Foundation board members and staff, and other invited attendees

Event Date: 12/07/2022
Location: Virtual
Subject: Priorities
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several participants from the Electronic Health Record Association

Event Date: 12/07/2022
Location: Washington, DC
Subject: Milken Institute Future of Health Summit
FDA Participant/Group: MICHAEL FELBERBAUM;
Non FDA Participant/Group: Government, academia, industry, media, and other registered attendees

Event Date: 12/07/2022
Location: Virtual
Subject: Independent Panel of Experts Report on FDA's Food Program Meeting
FDA Participant/Group: TRISTAN COLONIUS;
Non FDA Participant/Group: De Ann Davis (Western Growers);

Event Date: 12/08/2022
Location: Virtual
Subject: Pediatric Respiratory Illness Medical Products
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members from American Academy of Pediatrics, Children's Hospital Association, American Hospital Association, and American Academy of Family Physicians

Event Date: 12/08/2022
Location: Virtual
Subject: Supply Shortage
FDA Participant/Group: MICHELLE ADAMS; JULIA TIERNEY;
Non FDA Participant/Group: Dave Palew, Swami Iyer (Aurobindo);

Event Date: 12/08/2022
Location: Virtual
Subject: FDA Science Board
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, academia, and media

Event Date: 12/08/2022
Location: Virtual
Subject: American College of Cardiology Industry Advisory Forum
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, industry, academia and other registered attendees

Event Date: 12/08/2022
Location: Virtual
Subject: Independent Panel of Experts Report on FDA's Food Program Meeting
FDA Participant/Group: TRISTAN COLONIUS;
Non FDA Participant/Group: Peter Lurie (Center For Science in the Public Interest);

Event Date: 12/09/2022
Location: Virtual
Subject: Supply Shortage
FDA Participant/Group: JULIA TIERNEY; MICHELLE ADAMS;
Non FDA Participant/Group: Christine Baeder, Michael Brzica, Sven Edthlefs (Teva Pharmaceutical Industries);

Event Date: 12/09/2022
Location: Virtual
Subject: Supply Shortage
FDA Participant/Group: MICHELLE ADAMS; JULIA TIERNEY;
Non FDA Participant/Group: Brian Hoffmann, Dawn Culp, Mike Balog, Steve Weiss (Hikma Generics);

Event Date: 12/09/2022
Location: Virtual
Subject: Supply Shortage
FDA Participant/Group: JULIA TIERNEY; MICHELLE ADAMS;
Non FDA Participant/Group: Dimitra Nikopoulou, Ian Ball, Keren Haruvi, Kevin Cook, Len Arsenault, Richard Saynor (Sandoz);

Event Date: 12/09/2022
Location: Virtual
Subject: Respiratory Illness Medical Products Supply
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several stakeholders interested in discussing supply challenges in medical products needed to treat respiratory illnesses

Event Date: 12/09/2022
Location: Virtual
Subject: Supply Shortage
FDA Participant/Group: MICHELLE ADAMS; JULIA TIERNEY;
Non FDA Participant/Group: Linda Robbins, Patrick Cashman (US Antibiotics);

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

Event Date: 12/06/2022
Location: Washington, DC
Subject: 2022 Future of Health Summit
FDA Participant/Group: NAMANDJE BUMPUS; ROBYN BENT; PETER STEIN; THERESA MULLIN;
Non FDA Participant/Group: Industry, policymakers, philanthropists, patient advocates, health-care workers, global community leaders, entrepreneurs, academics, investors, providers, payers, employers, researchers, and scientists

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: 12/06/2022
Location: Silver Spring, MD
Subject: Food Safety Issues of Mutual Interest
FDA Participant/Group: JASMINE SMITH-DULLEY;
Non FDA Participant/Group: Drew McDonald (Taylor Farms); Jim Brennan (New Leaf Foods);

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: Namandjé N. Bumpus, Ph.D., Chief Scientist

Event Date: 12/06/2022
Location: Washington, DC
Subject: Future of Health Summit 2022; Speaker: Innovation in Biomarker Development and Deployment
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, academia, industry, media and other registered attendees

Event Date: 12/08/2022
Location: Washington, DC
Subject: Women in Bio; Keynote Speaker
FDA Participant/Group: N/A
Non FDA Participant/Group: Capital Region Chapter of Women In Bio (WIB)

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

Event Date: 12/07/2022
Location: Virtual
Subject: The Drug Supply Chain Security Act (DSCSA) Implementation and Readiness Efforts for 2023 Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, government, and other stakeholders

Event Date: 12/07/2022
Location: Virtual
Subject: International Coalition of Medicines Regulatory Authorities (ICMRA) Executive Committee Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives of European Medicines Agency

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

Event Date: 12/07/2022
Location: Virtual
Subject: 2022 BioMAN Summit - Platform and Process Innovation for Cell and Gene Therapy Manufacturing; Speaker: The Importance of Manufacturing in Cell and Gene Therapy Development
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the 2022 BioMAN Summit

Event Date: 12/07/2022
Location: Virtual
Subject: Danaher Genomic Medicines Summit - Genomes to Cures; Speaker: A Visionary View on the Future of Genomic Medicines
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of Danaher Genomic Medicines Summit - Genomes to Cures

Event Date: 12/09/2022
Location: Virtual
Subject: Paul Ehrlich Institute Symposium - Development and Regulation of Vaccines and Biomedicines; Speaker: Advancing Biologics Regulation Through Applied Scientific Research
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the Paul Ehrlich Institute Symposium: Development and Regulation of Vaccines and Biomedicines

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

Event Date: 12/06/2022
Location: Virtual
Subject: Massachusetts Medical Device Industry Council (MassMEDIC) Regulatory Roundup; Speaker: CDRH Strategic Priorities and Center Updates
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, government, academia, and other stakeholders

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

Event Date: 12/05/2022
Location: Virtual
Subject: American Bakers Association (ABA) Science and Regulatory Council Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: American Bakers Association (ABA) Science and Regulatory Council members

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

Event Date: 12/09/2022
Location: Virtual
Subject: Introductory Meeting and Program Update
FDA Participant/Group: N/A
Non FDA Participant/Group: Representative Abigail Spanberger (D-VA)

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

Event Date: 12/09/2022
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: N/A
Non FDA Participant/Group: Stephanie Batliner (Generic Animal Drug Affiliation );

Event Date: 12/09/2022
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: N/A
Non FDA Participant/Group: Steven Roach (Keep Antibiotics Working);

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

No Significant Event

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

No Significant Event