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  5. Public Calendar: December 1-7, 2019
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: December 1-7, 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: 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: 12/03/2019
Location: Arlington, VA
Subject: FDA/CMS Summit 2019
FDA Participant/Group: PETER STEIN; JANET MAYNARD; TEJASHRI PUROHIT-SHETH; LINDA RICCI; KHUSHBOO SHARMA; JOSEPH FRANKLIN; JANET WOODCOCK;
Non FDA Participant/Group: Attendees from government, industry, academia, and the media

Event Date: 12/04/2019
Location: Silver Spring, MD
Subject: FDA-Pharmaceutical Research and Manufacturers of America (PhRMA) Digital Health Technologies and Medical Product Development Listening Session
FDA Participant/Group: ANDREW KISH; ANAHITA LOLOEI MARSAL; JOSEPH FRANKLIN; MIMI NGUYEN; JACQUELINE CORRIGAN CURAY; MARY SLACK; JESSICA BERRELLEZ; VIDYUT DESAI; UTA RAWSON; MATTHEW DIAMOND; PATRIZIA CAVAZZONI; JULIA TIERNEY; CHRISTOPHER JONECKIS;
Non FDA Participant/Group: Kelly Goldberg, Lucy Vereshchagina, Mary Kosinski, Matt Raymond, Rich Moscicki, Ryan Kaat (PhRMA); Brian Mayhew, Rob Kowalski, Vas Narasimhan (Novartis); Anne Heatherington (Takeda); Peter Bergethon (Biogen); Math Hukkelhoven (Bristol-Myers Squibb);

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

Event Date: 12/02/2019
Location: Tempe, AZ
Subject: 5th Annual Arizona Agribusiness Roundtable
FDA Participant/Group: MARK MOORMAN; PETER CASSELL; STEVEN MUSSER;
Non FDA Participant/Group: Attendees from industry, academia, and the media

Event Date: 12/03/2019
Location: Yuma, AZ
Subject: Yuma Fresh Vegetable Association Annual Meeting
FDA Participant/Group: PETER CASSELL; STEVEN MUSSER; MARK MOORMAN;
Non FDA Participant/Group: Attendees from industry, academia, and the media

Event Date: 12/03/2019
Location: Yuma, AZ
Subject: Arizona Western College Students Meeting on Food Safety
FDA Participant/Group: STEVEN MUSSER; PETER CASSELL; MARK MOORMAN;
Non FDA Participant/Group: Attendees from academia and media

Event Date: 12/05/2019
Location: Washington D.C.
Subject: Sally Squires Breakfast Club Panel Session
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees from industry, academia, and the media

Event Date: 12/06/2019
Location: Washington D.C.
Subject: FDA/Food and Beverage Industry Coalition Meeting
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Several members from the food and beverage industry

Official Name: Lowell Schiller, Principal Associate Commissioner for Policy

Event Date: 12/06/2019
Location: Silver Spring, MD
Subject: FDA / Health Canada Bilateral Meeting
FDA Participant/Group: APRIL ALEXANDROW; DOUGLAS THROCKMORTON; MELISSA ROBB; KRISTI HAMPTON; MICHELLE HINES; STEVEN TAVE; STEVEN SOLOMON; SHARON MAYL; MARK ABDOO; PETER STEIN; KAREN LONG; MATTHEW LUCIA; MARY LOU VALDEZ; AMY ABERNETHY; JOSEPH FRANKLIN; NICHOLAS ALEXANDER;
Non FDA Participant/Group: Ed Morgan, John Patrick Stewart, Kendal Weber, Manon Bombardier, Mary Jane Ireland (Health Products and Food Branch (HPFB)); Andrea Budgell, Linsey Hollett, Lisa Lange, Marc Mes, Robin Churchill, Sophie Sommerer, Stephanie Jack (Controlled Substances and Cannabis Branch (CSCB));

No Significant Event

Official Name: Melinda Plaisier, Associate Commissioner for Regulatory Affairs

No Significant Event

Official Name: Mark Abdoo, Associate Commissioner for Global Policy and Strategy

Event Date: 12/06/2019
Location: Silver Spring, MD
Subject: US-Switzerland Mutual Recognition Agreement
FDA Participant/Group: JADE PHAM, JOSEPH REIRAS, RAVI BHARWANI
Non FDA Participant/Group: Phillippe Girard (Swissmedic), Federico Cimini (Swissmedic), Helga Horisberger (Swissmedic), Gabriela Zenhaeusern (Swissmedic)

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

Event Date: 12/05/2019
Location: North Bethesda, MD
Subject: International Society for Pharmaceutical Engineering (ISPE) Regulatory Conference: Keynote Address
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees from industry, academia, and the media

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

Event Date: 12/06/2019
Location: Orlando, FL
Subject: 61st American Society of Hematology (ASH) Annual Meeting: Some Regulatory Considerations for Gene Therapy Development
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees from industry, academia, and the media

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

Event Date: 12/02/2019
Location: Silver Sping, MD
Subject: General Medical Device Discussion
FDA Participant/Group: CAROLYN NEULAND; ELLEN FLANNERY; DAVID SULLIVAN; BENJAMIN FISHER; FRANK HURST; WILLIAM MAISEL; OWEN FARIS; DOUGLAS SILVERSTEIN;
Non FDA Participant/Group: Jesse Seidman, Lynn Pawelski, Merle Goddard, Sumant Ramachandra , Tobi Karchmer (Baxter);

Event Date: 12/03/2019
Location: Silver Spring, MD
Subject: General Medical Device Discussion
FDA Participant/Group: TIMOTHY STENZEL;
Non FDA Participant/Group: Robert Ford (Abbott);

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: 12/03/2019
Location: Washington, DC
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: NEAL BATALLER; NADINE STEINBERG; MARGARET OELLER; CINDY BURNSTEEL; SIOBHAN DELANCEY; TRACEY FORFA; WILLIAM FLYNN; PATRICK MCDERMOTT; MATTHEW LUCIA;
Non FDA Participant/Group: Attendees from The Pew Charitable Trusts

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

Event Date: 12/03/2019
Location: Little Rock, AR
Subject: National Center for Toxicological Research (NCTR) Science Advisory Board
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: N/A

Official Name: Stacy Cline Amin, Chief Counsel

No Significant Event