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  5. Public Calendar: September 10-16, 2023
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: September 10-16, 2023

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 for Food and Drugs

Event Date: 09/11/2023
Location: Washington, DC
Subject: Supporting the Use of Real-World Data in Oncology Drug Development
FDA Participant/Group: PALLAVI MISHRA-KALYANI; DAYLE CRISTINZIO; DONNA RIVERA;
Non FDA Participant/Group: Industry, academia, government, and media

Event Date: 09/11/2023
Location: Virtual
Subject: Chronic Disease Working Session - Long COVID
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several stakeholders interested in Long COVID

Event Date: 09/12/2023
Location: Virtual
Subject: Compounding Quality Center of Excellence Annual Conference; Ten Years as a Regulated Outsourcing Facility Industry: Addressing Challenges to Improve Patient Care
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, government, academia, and media

Event Date: 09/13/2023
Location: Virtual
Subject: Advancing Generic Drug Development: Translating Science to Approval
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, government, academia, and media

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

Event Date: 09/12/2023
Location: Virtual
Subject: Food and Drug / National Association of State Departments of Agriculture (NASDA) Meeting
FDA Participant/Group: TRACEY FORFA; BARBARA CASSENS; MICHAEL DUTCHER; ERIK METTLER; DONALD PRATER;
Non FDA Participant/Group: NASDA senior executives from several states

Official Name: Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs

No Significant Event

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

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

Event Date: 09/14/2023
Location: Virtual
Subject: Joint Workshop on European Medicines Agency and U.S. Food and Drug Administration Collaborations; Remarks
FDA Participant/Group: N/A
Non FDA Participant/Group: Workshop attendees

Official Name: Carol Cave, Acting Associate Commissioner for Regulatory Affairs

No Significant Event

Official Name: Heidi Rebello, Acting Associate Commissioner for External Affairs

No Significant Event

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

Event Date: 09/12/2023
Location: Washington, DC
Subject: State University System of Florida Federal Research Agency Day
FDA Participant/Group: N/A
Non FDA Participant/Group: Lewis-Burke Associates LLC

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

Event Date: 09/11/2023
Location: Virtual
Subject: Quarterly Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Leadership of Foundation for National Institutes of Health (FNIH)

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

Event Date: 09/13/2023
Location: Piscataway, NJ
Subject: 2023 BioNJ Manufacturing Briefing: Rising to the Challenge: Manufacturing and Supplying Therapies in Today's Reality; The Importance of Biotherapeutics Manufacturing: Quality by Design
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the 2023 BioNJ Manufacturing Briefing: Rising to the Challenge: Manufacturing and Supplying Therapies in Today's Reality

Event Date: 09/14/2023
Location: Boston, MA
Subject: Rett Syndrome Genetic Medicines Summit; Evolving Regulatory Landscape for Biologic Therapeutics in Orphan Diseases
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the Rett Syndrome Genetic Medicines Summit

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

Event Date: 09/13/2023
Location: Virtual
Subject: CDRH Patient Engagement Town Hall: Opening Remarks
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Patients and patient groups

Event Date: 09/15/2023
Location: Virtual
Subject: General Medical Device and Partnership Updates
FDA Participant/Group: TROY TAZBAZ; BRITTANY CALDWELL; TIMOTHY STENZEL; EVA RORER; AFTIN ROSS; SUZANNE SCHWARTZ; ANINDITA SAHA; MICHAEL WALKER; LINDA RICCI;
Non FDA Participant/Group: Andrew Fish, Joseph Sapiente (Medical Device Innovation Consortium);

Official Name: Donald Prater, Acting Director, Center for Food Safety and Applied Nutrition

Event Date: 09/13/2023
Location: Mexico City, Mexico
Subject: Annual Food Safety Partnership Meeting
FDA Participant/Group: SAMIR ASSAR; GIRVIN LIGGANS; RAVI BHARWANI; MAURICIO CASTELO; MICHELLE RODRIGUEZ; MICHAEL ROGERS; ANGELA FIELDS; VANESSA NOELTE; YINQING MA; ANA LILIA SANDOVAL; JULIE MOSS;
Non FDA Participant/Group: Amina Hayat Achaibou Taright, Armida Zúñiga Estrada, Bertha María Alcalde Luján, Cynthia Anahí Puga Arreola, Dalila Yvvet Fernández Hernández, Gabriela Ofelia Ibarra Cruz, Imelda Rocío Guzmán Cervantes, Jessica Liliana Gutiérrez Gómez, Juan León Ojeda, María Guadalupe Arizmendi Ramírez, Miriam Jackeline Loera Rosales, Pablo Alberto Quiroga Adame, Rafael Hernández Medina, Verónica Berrones Zapata (Federal Commission for Protection against Health Risks); Cindy Fabiola Hernández Pérez, Francisco Javier Calderon Elizalde, Jesús Alejandro Galindo Villalobos, Jesús Reyes Ramírez, José Luis Lara de la Cruz, Leandro David Soriano García, Mayren Cristina Zamora Nava, Mónica Yazmín López Sánchez, Raúl Martínez Chávez, Víctor Manuel López Herrera (National Service of Health, Food Safety and Quality);

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

Event Date: 09/11/2023
Location: Silver Spring, MD
Subject: Campaign for Tobacco Free Kids (CTFK) Introductory Meeting: Center and Campaign Priorities
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several representatives from Campaign for Tobacco Free Kids

Event Date: 09/12/2023
Location: Silver Spring, MD
Subject: American Academy of Pediatrics (AAP) Introductory Meeting: Nicotine Concentrations, E-Cigarette Public Health Reviews, Collaboration Opportunities
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several representatives from the American Academy of Pediatrics

Event Date: 09/14/2023
Location: Virtual
Subject: Action on Smoking Health (ASH) Webinar; Regulating Tobacco Products: An International, Federal and State Level Perspective
FDA Participant/Group: N/A
Non FDA Participant/Group: Several representatives and attendees from Action on Smoking Health

Official Name: Tracey H. Forfa, J.D., Director, Center for Veterinary Medicine

Event Date: 09/14/2023
Location: Rockville, MD
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives of Elanco Animal Health

Official Name: Tucker Patterson, 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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