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