Public Calendar: April 7-13, 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
No Significant Event
Official Name: Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner
Event Date: 04/08/2019
Location: Boston, MA
Subject: World Medical Innovation Forum: Real World Evidence (RWE) and Trial Optimization in the Al Era
FDA Participant/Group: BAKUL PATEL;
Non FDA Participant/Group: Tom Lynch (Bristol-Myers Squibb Company); Mike Devoy (Bayer AG); Joshua Mandel (Microsoft); Vicki Seyfert-Margolis (MyOwnMed); Stephen Wiviott (Harvard Medical School)
Official Name: Anna Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis
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: 04/08/2019
Location: Silver Spring, MD
Subject: Gold Medal Flour Recall Meeting
FDA Participant/Group: MICKEY PARISH; WILLIAM CORRELL; DOUGLAS TICKER; CAITLIN BOON; DOUGLAS STEARN;
Non FDA Participant/Group: Kelly Stevens, Mark Fryling, Scott Hood (General Mills Inc.);
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
Event Date: 04/08/2019
Location: Silver Spring, MD
Subject: Introduction to Canada Drug Shortage Work
FDA Participant/Group: Several members from the FDA Drug Shortages Task Force
Non FDA Participant/Group: Stephanie Di Trapani (Government of Canada);
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: 04/08/2019
Location: Rockville, MD
Subject: The 2019 Muscular Dystrophy Association Conference: CDER's Initiatives and Modernization Efforts
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees at the Muscular Dystrophy Clinical and Scientific Conference
Official Name: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
Event Date: 04/12/2019
Location: Oxon Hill, MD
Subject: World Orphan Drug Congress USA 2019: FDA’s Efforts to Expedite the Development of Regenerative Medicine Advanced Therapy (RMAT) Products
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
Event Date: 04/09/2019
Location: Washington, DC
Subject: Deputy Secretary’s Innovation and Investment Summit: Regulatory Approval and Reimbursement Best Practices
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A
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: 04/09/2019
Location: Rockville, MD
Subject: CVM: Veterinary Issues of Mutual Interest
FDA Participant/Group: JOHN MUSSMAN; NADINE STEINBERG; HEATHER HARBOTTLE; TIMOTHY SCHELL; JEFFREY GILBERT; SUSAN BRIGHT-PONTE; ASHLEY STEEL; MICHAEL MURPHY; MATTHEW LUCIA; WILLIAM FLYNN; NEAL BATALLER; PATRICK MCDERMOTT; CINDY BURNSTEEL; SIOBHAN DELANCEY;
Non FDA Participant/Group: Jaydee Hanson (Center for Food Safety); Patrica Buck (Center for Foodborne Illness Research and Prevention); Madeleine Klevin (Keep Antibiotics Working); Steve Roach (Food Animal Concerns Trust); Michael Hansen (Consumer Reports); Sarah Sorscher, Eva Greenthal (Center for Science in the Public Interest); Sarah Goldman (Johns Hopkins University); Laura Rogers (George Washington University); Matt Wellington (Public Interest Research Group); Mae Wum (Natural Resource Defense Council);
Official Name: William Slikker, Jr., Ph.D., Director, National Center for Toxicological Research
Event Date: 04/10/2019
Location: Little Rock, AR
Subject: University of Arkansas for Medical Sciences: National Center for Toxicological Research: Showcase for Medical Discoveries
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A
Official Name: Stacy Cline Amin, Chief Counsel
No Significant Event