Public Calendar: May 12-18, 2019
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: Norman E. Sharpless, M.D. (Acting), Commissioner of Food and Drugs
Event Date: 05/13/2019
Location: Silver Spring, MD
Subject: Public Hearing: The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Academia, media, industry, government, and the general public
Event Date: 05/15/2019
Location: Rockville, MD
Subject: FDA and Animal Health Institute Meeting
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Several members from the Animal Health Institute
Event Date: 05/15/2019
Location: Silver Spring, MD
Subject: Youth Tobacco Cessation Workshop: Science and Treatment Strategies
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Goverment, media, industry, and other registered guests
Event Date: 05/16/2019
Location: Silver Spring, MD
Subject: Public Workshop: Project Facilitate: Enhancing the Single Patient Investigational New Drug Process for Oncology Health Care Providers
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Government, industry, media, and other registered guests
Event Date: 05/16/2019
Location: College Park, MD
Subject: Public Meeting: Responsible Innovation in Dietary Supplements
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Government, media, industry, and other registered guests
Official Name: Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner
Event Date: 05/14/2019
Location: New York
Subject: Financial Times US Pharma and Biotech Summit: Patient Owned Data
FDA Participant/Group: N/A
Non FDA Participant/Group: Several attendees from government, industry, and members of the health care services field
Official Name: Anna Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis
No Significant Event
Official Name: Lowell J. Schiller, Principal Associate Commissioner for Policy
No Significant Event
Official Name: Mark Abdoo, Acting Deputy Commissioner for Global Regulatory Operations and Policy
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: 05/14/2019
Location: Atlanta, GA
Subject: 2019 FoodNet Vision Meeting: Traceability and Blockchain Efforts Update
FDA Participant/Group: CAITLIN BOON; ORVILLE HARRIS; DAVID GOLDMAN;
Non FDA Participant/Group: Mindy Brashears, Kis Robertson (The U.S. Department of Agriculture) Christopher Braden, Rima Khabbaz, Robert Tauxe (Centers for Disease Control and Prevention); several members from the Centers for Disease Control and Prevention; and industry representatives
Event Date: 05/16/2019
Location: Washington, DC
Subject: Board of Directors Meeting: Produce Safety
FDA Participant/Group: JAMES GORNY; CAITLIN BOON; ORVILLE HARRIS; JEFFREY FARRAR; KARI IRVIN;
Non FDA Participant/Group: David Pugila, Dennis Nuxoll, Hank Giclas, Jason Resnick, Tom Nassif (Western Growers); several stakeholders, and industry participants
Official Name: Melinda Plaisier, Associate Commissioner for Regulatory Affairs
No Significant Event
Official Name: Mary Lou Valdez, M.S.M., Associate Commissioner for International Programs
No Significant Event
Official Name: Keagan Lenihan, Associate Commissioner for External Affairs
No Significant Event
Official Name: RADM Denise Hinton, Chief Scientist
No Significant Event
Official Name: Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research
Event Date: 05/17/2019
Location: Washington, DC
Subject: Update on FDA Activities: Biosimilars and Interchangeable Products
FDA Participant/Group: N/A
Non FDA Participant/Group: Several members from the American College of Rheumatology Board of Directors
Official Name: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
Event Date: 05/14/2019
Location: Portland, OR
Subject: State of the Science Conference on Extracorporeal Photopheresis: American Society for Apheresis 2019 Annual Meeting: Balancing Safety and Innovation for Cell-Based Regenerative Medicine
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A
Event Date: 05/15/2019
Location: Portland, OR
Subject: Oregon Community Foundation Meeting: Blood Donation Policies
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A
Event Date: 05/16/2019
Location: Portland, OR
Subject: State of the Science Conference on Extracorporeal Photopheresis: American Society for Apheresis 2019 Annual Meeting: Facilitating the Development of Cell and Gene Therapies
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A
Event Date: 05/17/2019
Location: Washington, DC
Subject: Friends of Cancer Research: Designing the Future of Cell Therapies: Fireside Chat: Future Directions for Cell and Gene Therapies
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A
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
Event Date: 05/16/2019
Location: Silver Spring, MD
Subject: Advancing the Safety of Leafy Greens
FDA Participant/Group: LARRY MORRIS; CAITLIN BOON; MICHAEL ROGERS; JAMES GORNY; DOUGLAS STEARN;
Non FDA Participant/Group: Howard Popoola (The Kroger Co.); Mike Taylor (Stop Foodborne Illness); Felice Arboisiere, Kathleen Ensley (Yum! Brands RSC); Danny Wegman, Dave Corsi, Gillian Kelleher (Wegmans Food Markets); Tejas Bhatt (Walmart );
Event Date: 05/16/2019
Location: Washington, DC
Subject: Nutrition Innovation Strategy
FDA Participant/Group: N/A
Non FDA Participant/Group: Several representatives from the rice industry
Event Date: 05/17/2019
Location: College Park, MD
Subject: Health and Chemicals Coalition Quarterly Meeting
FDA Participant/Group: MARIANNA NAUM; SUZANNE FITZPATRICK; DAVID GOLDMAN; LAURA GOTTSCHALK; CONRAD CHOINIERE; MARIANNA NAUM; JENNIFER DOOREN; LAURA GOTTSCHALK; PAUL SOUTH; DENNIS KEEFE; LISA DAVIS; KARI BARRETT;
Non FDA Participant/Group: Carrie Apfel, Peter Lehner (Earthjustice); Maureen Swanson (Learning Disabilities Association of America); Alissa Sasso, Boma Brown-West, Joanna Slaney, Maricel Maffini, Sam Lovell, Tom Neltner (Environmental Defense Fund); Jaydee Hanson (Center for Food Safety); Alyssa Katzenelson, Dave Andrews, Olga Naidenko (Environmental Working Group); Lisette van Vliet (Breast Cancer Prevent Partners); Laura MacCleery, Lisa Lefferts (Center for Science in the Public Interest); Charlotte Brody (Healthy Babies Bright Futures); Will Wallace (Consumers Reports); Jackie Bowen (Clean Label Project); Eric Olson (Natural Resources Defense Council);
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: 05/14/2019
Location: Wash., D.C.
Subject: Animal Health Institute Board of Directors Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Animal Health Institute
Official Name: William Slikker, Jr., Ph.D., Director, National Center for Toxicological Research
No Significant Event
Official Name: Stacy Cline Amin, Chief Counsel
No Significant Event