Public Calendar: November 3-9, 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: Brett P. Giroir, M.D, Acting Commissioner of Food and Drugs
No Significant Event
Official Name: Amy Abernethy, M.D., Ph.D, Principal Deputy Commissioner
Event Date: 11/04/2019
Location: Silver Spring, MD
Subject: Meeting with Global Genes/RARE-X
FDA Participant/Group: PETER STEIN; JOSEPH FRANKLIN; MARY SLACK; PATRIZIA CAVAZZONI; JACQUELINE CORRIGAN CURAY; THERESA MULLIN; JANET WOODCOCK;
Non FDA Participant/Group: Harsha Rajasimha, James Valentine, Nicole Boice, Vanessa Vogel Farley (RARE-X); Anthony Philippakis, Danielle Ciofani (Broad Institute);
Event Date: 11/05/2019
Location: Silver Spring, MD
Subject: FDA/PhRMA-BIO CEO Meeting: PDUFA VI Implementation Progress
FDA Participant/Group: JANET WOODCOCK; JAMES TYLER; CHRISTOPHER JONECKIS; JOSEPH FRANKLIN; ANGELA GRANUM; THERESA MULLIN; ANDREW KISH; PATRICK ZHOU; PATRIZIA CAVAZZONI; AMANDA EDMONDS; PETER STEIN; KHUSHBOO SHARMA; MELANIE KELLER;
Non FDA Participant/Group: Cartier Esham, James Greenwood, John Murphy, Tom Dilenge (BIO); James Stansel, Kelly Goldberg, Lucy Vereshchagina, Mary Kosinski, Richard Moscicki, Steve Ubl (PhRMA); Richard Pops (Alkermes); Giovanni Caforio (Bristol-Myers Squibb);
Event Date: 11/05/2019
Location: Washington, DC
Subject: Meeting with Leadership of the Bipartisan Policy Center (BPC) Report on Real World Evidence
FDA Participant/Group: JOSEPH FRANKLIN;
Non FDA Participant/Group: Andy von Eschenbach, Janet Marchibroda, Mark McClellan, Robert Califf (BPC);
Event Date: 11/08/2019
Location: Silver Spring, MD
Subject: American Society of Hematology (ASH) Research Collaborative
FDA Participant/Group: Several FDA Officials and Staff Members
Non FDA Participant/Group: Alexisw Thompson, Charles Chesson, Charles S. Abrams, Edward J. Benz, Jr., Kathleen Hewitt, Kenneth C. Anderson, LaTasha Lee, Matthew Gertzog, Robert Plovnick, Shell Walser, Stephanie Kaplan, Suzanne Leous, Uchenna Onyeachom, William A. Wood (ASH);
Official Name: Anna Abram, 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
No Significant Event
Official Name: Lowell Schiller, Principal Associate Commissioner for Policy
Event Date: 11/07/2019
Location: Carlsbad, CA
Subject: Council for Responsible Nutrition (CRN) 2019 Annual Symposium for Dietary Supplements Industry Conference; Speaker: Perspectives From FDA
FDA Participant/Group: N/A
Non FDA Participant/Group: Registered attendees from industry, government, and academia
No Significant Event
Official Name: Mark Abdoo, Associate Commissioner for Global Policy and Strategy
No Significant Event
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: Laura Caliguiri, 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
No Significant Event
Official Name: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
Event Date: 11/04/2019
Location: Washington, DC
Subject: The Relevance of Global Convergence to Accelerating the Availability of Gene Therapies
FDA Participant/Group: N/A
Non FDA Participant/Group: Representatives from American Society of Gene & Cell Therapy
Event Date: 11/06/2019
Location: Toronto, Canada
Subject: Opening Session of Canadian Blood Services’ Men Who Have Had Sex With Men (MSM) Research Program Knowledge Synthesis Forum
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
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
No Significant Event
Official Name: William Slikker, Jr., Ph.D., Director, National Center for Toxicological Research
Event Date: 11/03/2019
Location: San Antonio, TX
Subject: American Association of Pharmaceutical Scientists (AAPS)
FDA Participant/Group: WILLIAM SLIKKER;
Non FDA Participant/Group: Government, industry, academia, and other invited guests
Official Name: Stacy Cline Amin, Chief Counsel
No Significant Event