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  5. Public Calendar: March 10-16, 2019
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: March 10-16, 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: Scott Gottlieb, M.D., Commissioner of Food and Drugs

Event Date: 03/13/2019
Location: Silver Spring, MD
Subject: FDA's Youth Tobacco Prevention Efforts
FDA Participant/Group: CARLYLE MCWILLIAMS; PERHAM GORJI; ANN SIMONEAU; MITCHELL ZELLER; ROBIN APPLEBERRY; MICHELE MITAL; LAUREN ROTH; LINDSAY TOBIAS; AMY ABERNETHY; STACY AMIN; JOSEPHINE TROPEA; DAVID MEDNICK; LAUREN SILVIS;
Non FDA Participant/Group: Howard Willard, Jose Luis Murillo, Murray Garnick, Todd Walker (Altria Group, Inc.); Daniel Cruise, Jerry Masoudi, Joanna Engelke, Kevin Burns (JUUL Labs, Inc.);

Event Date: 03/14/2019
Location: Washington, DC
Subject: Association of Clinical Trials Research Organizations Board of Directors Meeting: Modernizing Clinical Trials
FDA Participant/Group: LAUREN SILVIS;
Non FDA Participant/Group: Several members from the Association of Clinical Research Organizations

Official Name: Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner

No Significant Event

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 & Response

Event Date: 03/12/2019
Location: Silver Spring, MD
Subject: National Farmers Union Meeting: Food Safety Modernization Act (FSMA)
FDA Participant/Group: LARRY MORRIS; LAUREN BERKOWITZ; SCARLETT SALEM; FAZILA SHAKIR; JAMES GORNY; CATHERINE MCDERMOTT; SAMIR ASSAR;
Non FDA Participant/Group: Billy Mitchell, Camilla Posthill, Chelsea Matzen, Tom Driscoll (National Farmers Union);

Event Date: 03/12/2019
Location: Gaithersburg, MD
Subject: Association of Official Agricultural Chemists (AOAC International): Analytical Solutions Forum: Analytical Needs to Support Future Regulatory Food Safety and Food Defense Programs
FDA Participant/Group: N/A
Non FDA Participant/Group: Several participants from the Association of Official Agricultural Chemists

Event Date: 03/13/2019
Location: College Park, MD
Subject: Food Marketing Institute Meeting: Food Safety for Retailers
FDA Participant/Group: TRACEY SANDERS; DOUGLAS STEARN; REBECCA BUCKNER; DAVID GOLDMAN; CAITLIN BOON; CLAUDINE KAVANAUGH;
Non FDA Participant/Group: Hilary Thesmar, Jennifer Hatcher, Leslie Sarasin, Stephanie Harris (Food Marketing Institute); Robert Garfield (Safe Quality Food Institute);

Event Date: 03/14/2019
Location: Washington, DC
Subject: Consumer Federation of America: 42nd Annual National Food Policy Conference: Food Safety
FDA Participant/Group: N/A
Non FDA Participant/Group: Several members of national food policy groups

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

No Significant Event

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

Event Date: 03/14/2019
Location: Washington, DC
Subject: American Society for Clinical Pharmacology and Therapeutics Annual Meeting: FDA's Regulatory Framework for Chimeric Antigen Receptor–T Cell Therapies
FDA Participant/Group: N/A
Non FDA Participant/Group: Several clinical pharmacologists, translational researchers, and other scientists

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

Event Date: 03/12/2019
Location: Silver Spring, MD
Subject: Artificial Intelligence and Digital Health Devices
FDA Participant/Group: WILLIAM MAISEL; LINDA RICCI; ANGELA KRUEGER; DANIEL CANOS; BRAM ZUCKERMAN; JILL MARION; SOMA KALB; OWEN FARIS; BAKUL PATEL;
Non FDA Participant/Group: Martha Lawrence (AccendoWave); Brittany Blocker, Jimmy Jackson, Joe Panetta, Laure Fabrega (Biocom); Joe Stein (Scripps Health); Alexandre Gapihan, Barbara Binzak Blumenfeld (Buchanan Ingersoll & Rooney); Helen Ma (Ji Informatics ); Jessica Johnston (Becton Dickinson);

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: 03/14/2019
Location: Rockville, MD
Subject: CVM: Veterinary Issues of Mutual Interest
FDA Participant/Group: CINDY BURNSTEEL; SIOBHAN DELANCEY; ANNE NORRIS; ASHLEY STEEL; MARGARET OELLER; MATTHEW LUCIA; TIMOTHY SCHELL; SUSAN BRIGHT-PONTE; WILLIAM FLYNN;
Non FDA Participant/Group: Several members from the Pew Charitable Trusts organization

Official Name: William Slikker, Jr., Ph.D., Director, National Center for Toxicological Research

Event Date: 03/10/2019
Location: Baltimore, Maryland
Subject: Society of Toxicology: 58th Annual Meeting and ToxExpo: Scaling Barriers: Cellular Dynamics and Models of Blood-Brain Barrier Developmental Toxicity
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

Official Name: Stacy Cline Amin, Chief Counsel

Event Date: 03/14/2019
Location: Silver Spring, Maryland
Subject: Issue Related to Approved New Drug Application
FDA Participant/Group: KEVIN MAGUIRE; ELIZABETH KELLEY; ANNAMARIE KEMPIC; CLAUDIA ZUCKERMAN; JENNIFER KANG; FRANCIS GODWIN; ELIZABETH DICKINSON; JANICE BROWN; NICHOLAS BESHARA; ASHLEY BOAM; MILIND GANJAWALA;
Non FDA Participant/Group: Gerardo Mendez, Jeff Tabatabai, Jerry Roth (Hill Dermaceuticals, Inc.); Sheldon Bradshaw (King & Spalding, LLP); Larry Roth (The Roth Law Firm );

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