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  5. Public Calendar: December 2-8, 2018
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: December 2-8, 2018

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: 12/04/2018
Location: Washington, DC
Subject: Reagan-Udall Foundation: 2018 Innovations in Regulatory Science Awards Dinner
FDA Participant/Group: Several FDA officials and staff
Non FDA Participant/Group: Industry, government, and other invited guests

Official Name: Rachel Sherman, M.D., M.P.H.,, 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: Stephen Ostroff, Deputy Commissioner for Food Policy & Response

Event Date: 12/04/2018
Location: Silver Spring, MD
Subject: Food Safety
FDA Participant/Group: N/A
Non FDA Participant/Group: Roger Johnson, Tom Driscoll (National Farmers Union);

Event Date: 12/07/2018
Location: College Park, MD
Subject: Food Safety Implementation Act
FDA Participant/Group: N/A
Non FDA Participant/Group: Ray Yoder (Yoder's Farm, LLC);

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: 12/05/2018
Location: Newark, NJ
Subject: New Jersey Innovation Institute: FDA’s Efforts to Advance Manufacturing for Cellular and Gene Therapies
FDA Participant/Group: MANUEL OSORIO; DAVID CHO;
Non FDA Participant/Group: Several representatives from the biopharmaceutical industry

Event Date: 12/07/2018
Location: Silver Spring, MD
Subject: Public Workshop: Quantitation of Adeno-Associated Virus-Based Gene Therapy Products
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Several representatives from academia, industry, and other stakeholders involved in research, development, and regulation of adeno-associated virus-based gene therapy products

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

Event Date: 12/03/2018
Location: Silver Spring, MD
Subject: Butterfly Network’s Poseidon Ultrasound System
FDA Participant/Group: MARISA CRUZ; SHAHRAM VAEZY; BRIAN GARRA; MATTHEW DIAMOND; ROBERT OCHS; JONATHAN JAROW; MARJAN NABILI; JEFFREY BALLYNS; TIMOTHY STENZEL; BAKUL PATEL;
Non FDA Participant/Group: Jeff Gibbs (Hyman, Phelps & McNamara, P.C.); Gioel Molinari, John Martin (4Catalyzer Corporation);

Event Date: 12/03/2018
Location: Silver Spring, MD
Subject: Regulatory Aspects Specific to Artificial Intelligence
FDA Participant/Group: SHAWN FORREST; MATTHEW HILLEBRENNER; WILLIAM MAISEL; MATTHEW DIAMOND; BAKUL PATEL; STEPHEN BROWNING;
Non FDA Participant/Group: Campbell Rogers, Charles Taylor (HeartFlow Incorporated);

Event Date: 12/03/2018
Location: Silver Spring, MD
Subject: SurgiMend: Breast Reconstruction Surgery
FDA Participant/Group: SUNG YOON; JOSEPH NIELSEN; COURTNI WEATHERS; DAVID MEDNICK; OWEN FARIS; STACY AMIN; SHELBY BUETTNER; MICHAEL DELONG; WILLIAM MAISEL; GEMMA FLAMBERG; CYNTHIA CHANG; DAVID KRAUSE;
Non FDA Participant/Group: Lisa Dwyer, Mark Brown, Pete Leininger (King & Spalding LLP); Charles Bret Jessee (Integra LifeSciences LLC); David Cox, David Sheleheda, Judith O’Grady, Paul Sheridan (Integra LLC); Jesse Selber (The University of Texas MD Anderson Cancer Center);

Event Date: 12/07/2018
Location: Washington, DC
Subject: Advanced Medical Technology Association Board Meeting: General Medical Device Updates
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

No Significant Event

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

No Significant Event

Official Name: Stacy Cline Amin, Chief Counsel

Event Date: 12/07/2018
Location: Boston, MA
Subject: Seventh Annual Health Law Year in Pre/Review Symposium: The FDA in 2019: A Fireside Chat
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

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