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: 09/25/2023
Location: Hyderabad, India
Subject: Site Visit to the Asian Institute of Gastroenterology (AIG) Hospital and Grand Rounds; FDA Priorities and Emerging Clinical Research Issues in India
FDA Participant/Group: N/A
Non FDA Participant/Group: AIG leadership, Indian Society for Clinical Research (ISCR) leadership, academia, clinicians, and industry leaders

Event Date: 09/25/2023
Location: Hyderabad, India
Subject: CEO Forum Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Leadership from research industry

Event Date: 09/26/2023
Location: Telangana, India
Subject: Supply Chains and Adoption of New Technology
FDA Participant/Group: DHRUV SHAH; SUDHEENDRA KULKARNI; JESSICA STEWART; GREGORY SMITH; SARAH MCMULLEN; PADMASHRI NALUBOLA; PHUC NGUYEN; AMRITA KAUR; COURTNEY BUCHANAN;
Non FDA Participant/Group: Kiran Divi, Murali Divi, N.V. Ramana (Divi Laboratories);

Event Date: 09/26/2023
Location: Hyderabad, India
Subject: Telangana Technology Hub Site Visit
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: K.T. Rama Rao (Municipal Administration and Urban Development, Government of Telangana); Mahankali Srinivas Rao, Sujit Jagirdar (Telangana Technology Hub (T-Hub)); Jayesh Ranjan (Industries and Commerce (I&C), Government of Telangana); Jennifer Larson (U.S. State Department);

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

No Significant Event

Official Name: Jim Jones, Deputy Commissioner for Human Foods

Event Date: 09/28/2023
Location: College Park, MD
Subject: Food Safety Issues of Mutual Interest
FDA Participant/Group: KARI BARRETT; DONALD PRATER; LARRY MORRIS;
Non FDA Participant/Group: Mitzi Baum (STOP Foodborne Illness); Richelle Shields, Scott Shields, Susan Brayman (Consumer Advocate for STOP Foodborne Illness);

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

No Significant Event

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

No Significant Event

Official Name: Leah Hunter, Associate Commissioner for External Affairs

No Significant Event

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

Event Date: 09/26/2023
Location: Washington, DC
Subject: Implementation of the Modernization of Cosmetics Regulation Act (MoCRA) of 2022
FDA Participant/Group: ERIN O'QUINN;
Non FDA Participant/Group: Representative Jan Schakowsky (D-IL)

Event Date: 09/28/2023
Location: Virtual
Subject: Dr. Bumpus Profile and FDA Cosmetics Implementation Interview
FDA Participant/Group: COURTNEY RHODES;
Non FDA Participant/Group: Lauren Gardner (Politico Pro);

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

Event Date: 09/28/2023
Location: Silver Spring, MD
Subject: Collaborative Opportunities
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several Biocon executives

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

Event Date: 09/25/2023
Location: Virtual
Subject: R&D Speaker Series Lecture with Beam University: mRNA Summit with Mano Singh; FDA's Efforts to Facilitate the Application of mRNA Technologies
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the R&D Speaker Series Lecture with Beam University: mRNA Summit with Mano Singh

Event Date: 09/27/2023
Location: Silver Spring, MD
Subject: Cellular, Tissue, and Gene Therapies Advisory Committee Meeting; Amyotrophic Lateral Sclerosis
FDA Participant/Group: CELIA SILVERMAN;
Non FDA Participant/Group: Attendees of Cellular, Tissue, and Gene Therapies Advisory Committee Meeting

Event Date: 09/28/2023
Location: Washington, DC
Subject: Deloitte's NextGen Industry Working Group; Advancing Rare Disease Gene Therapy
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of Deloitte's NextGen Industry Working Group

Event Date: 09/28/2023
Location: National Harbor, MD
Subject: Defense Strategies Institute's Government Biotechnology Innovation Summit; Facilitating the Development of Safe and Effective Biologic Products Vital to Public Health
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the Defense Strategies Institute's Government Biotechnology Innovation Summit

Event Date: 09/29/2023
Location: Bethesda, MD
Subject: National Mucopolysaccharidoses (MPS) Society's 37th Annual Family Conference; Addressing the Unmet Needs of the Rare Disease Community
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the National Mucopolysaccharidoses (MPS) Society's 37th Annual Family Conference

Event Date: 09/30/2023
Location: New Brunswick, NJ
Subject: 2023 Sino-American Pharmaceutical Professionals Association (SAPA) Annual Conference; Advancing Biologic Therapeutics for Rare Diseases
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the 2023 Sino-American Pharmaceutical Professionals Association (SAPA) Annual Conference

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

Event Date: 09/28/2023
Location: Silver Spring, MD
Subject: General Medical Device Updates
FDA Participant/Group: WILLIAM MAISEL; LISA SIMONE; SCOTT STEFFEN; TAMMY BECKHAM; MICHAEL EPPIHIMER; EDWARD MARGERRISON; CLARENCE MURRAY; SUZANNE SCHWARTZ; LINDA RICCI; AFTIN ROSS; ANGELA KRUEGER; JENNIFER GOODE;
Non FDA Participant/Group: Geoff Martha, Scott Cundy, Laura Mauri, Olaf Hedrich, Yarmela Pavlovic, Cassie Scherer, Ken Washington, Kimberly Chaffin, Jeff Bodner, Kim Ganzel, Pat Duft (Medtronic)

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

Event Date: 09/26/2023
Location: Virtual
Subject: International Food Additive Council (IFAC) Priorities
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several representatives of International Food Additive Council (IFAC)

Event Date: 09/26/2023
Location: College Park, MD
Subject: Celiac Journey Public Policy Objectives
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Jax Bari, Jon Bari (Celiac Journey); Virgina Stallings (Children's Hospital of Philadelphia);

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

No Significant Event

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

Event Date: 09/28/2023
Location: Rockville, MD
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives of Nestle Purina

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

Event Date: 09/27/2023
Location: Parma, Italy
Subject: Global Summit on Regulatory Science; Speaker: Opening Remarks
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Academia, industry, and international government regulatory agencies

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

No Significant Event