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  5. Public Calendar: July 15- 21, 2018
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: July 15- 21, 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: 07/17/2018
Location: Washington, DC
Subject: Politico Pro Summit
FDA Participant/Group: Quinn, Kathleen K;
Non FDA Participant/Group: Government, academia, media, industry, and other registered guests

Event Date: 07/17/2018
Location: Silver Spring, MD
Subject: Policies Around Healthy Eating and Tobacco Control
FDA Participant/Group: Appleberry, Robin; Silvis, Lauren R; Alexander, Nicholas D; Mayne, Susan T; Simoneau, Ann L; Boon, Caitlin S; Chukwudebe, Nnaemeka R; Zeller, Mitchell R; Mital, Michele; Elwood, William R; Quinn, Kathleen K; Mckinnon, Robin A; Kavanaugh, Claudine J; Kropa, Halley E; Wood, Rebecca K;
Non FDA Participant/Group: Mary Bassett, Walter Bishop, Sam Miller, Sonia Angell (New York Department of Health and Mental Hygiene);

Event Date: 07/18/2018
Location: Washington, DC
Subject: Speech at the Brookings Institution: Dynamic Regulation: Key to Maintaining Balance Between Biosimilars Innovation and Competition
FDA Participant/Group: Devlin, Nina P;
Non FDA Participant/Group: Academia, government, industry, media, and other registered guests

Event Date: 07/18/2018
Location: Silver Spring, MD
Subject: Current PDUFA VI Implementations Progress Update
FDA Participant/Group: Joneckis, Christopher C; Mcwilliams, Carlyle S; Sigg, James M; Sherman, Rachel E; Abram, Anna K; Kish, Andrew K; Woodcock, Janet; Marks, Peter W; Barton, Joshua L; Edmonds, Amanda B; Tyler, James E; Silvis, Lauren R; Cavazzoni, Patrizia A; Keller, Melanie M; Elzarrad, Mohammed K;
Non FDA Participant/Group: John Maraganore (Alnylam); Richard Pops (Alkermes); Robert Bradway (Amgen Incorporated); Cartier Esham, Jim Greenwood, John Murphy (Biotechnology Innovation Organization); Giovanni Caforio (Bristol-Myers Squibb); James Stansel, Kelly Goldberg, Mary Kosinski, Steve Ubl (Pharmaceutical Research and Manufacturers of America);

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 M. Ostroff, M.D., Deputy Commissioner for Foods and Veterinary Medicine

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: Jennifer Rodriguez, Acting 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: 07/16/2018
Location: Philadelphia, PA
Subject: The 11th Annual Business of Regenerative Medicine: Innovation, Clinical Translation, and Entrepreneurship Symposium
FDA Participant/Group: N/A
Non FDA Participant/Group: Entrepreneurs, junior and senior scientists, business executives, investors, and analysts, technology transfer staff, and developmental personnel managers

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

Event Date: 07/17/2018
Location: Silver Spring, MD
Subject: Cybersecurity, Case for Quality, and Precertification Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Holger Schmidt, Eva Maria Reiter, Robert Phillips, Lars Becker, Noor Malki. Mazi Kiani, Stefan Leidenberger (Siemens Healthineers Incorporated);

Event Date: 07/18/2018
Location: Washington, DC
Subject: Real-World Evidence Workshop: Examining the Impact of Real-World Evidence on Medical Product Development
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

Event Date: 07/19/2018
Location: Silver Spring, MD
Subject: Evidence Generation Workshop
FDA Participant/Group: N/A
Non FDA Participant/Group: Michelle McMurry-Heath, Peter Schroeer, Makoto Sugita, Heather Colvin, Margarita Gomez, Paul Coplan, Michael Eppihimer, Piet Hinoul, Leonie Rynn, Anthony Hong, Carol Yan, LaMont Bryant, Philip Desjardins, Lisa Berlin, Patty Schleckser, Jesse Berlin, Robert Durgin, LeeMing Boo, Esther Thio, Amy Walriven, Paola Mussi, Nicoline van Leersum, Brian Vaughn, David Wheeler and Umesh Agrawal (Johnson & Johnson Services Incorporated);

Official Name: Susan T. Mayne Ph.D., Director, Center for Food Safety and Applied Nutrition

Event Date: 07/17/2018
Location: College Park, MD
Subject: Leafy Greens
FDA Participant/Group: Skelton, Leanne L; Irvin, Kari A; Johanson, Joy M; Assar, Samir K; Knirk, Maria S; Mahovic, Michael J; Barrett, Kari P; Jones, William R;
Non FDA Participant/Group: Lindsay Austin (Troutman Sanders Strategies); Steve Church (Church Brothers Farms, Limited Liability Company); Sharan Lanini (Pacific International Marketing); Gurmail Mudahar (Tanimura & Antle); Dan Sutton (Pismo Oceano Vegetable Exchange); Scott Horsfull (California Leafy Green Handler Marketing Agreement); Vicki Scott (Amigo Farms Incorporated); Teressa Lopez (Arizona Leafy Greens Marketing Agreement); Jan Berk (San Miguel Produce Incorporated); Ron Ratto (Ratto Brothers Incorporated);

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: 07/19/2018
Location: Rockville, MD
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: Delancey, Siobhan M; Hartogensis, Martine L; Edwards, David B; Murphy, Jeanette B;
Non FDA Participant/Group: Dana Brooks (Pet Food Institute);

Event Date: 07/20/2018
Location: Rockville, MD
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: Flynn, William T; Epstein, Laura R; Lombardi, Heather A; Lucia, Matthew A;
Non FDA Participant/Group: Clint Nesbitt, Dan Jenkins, Dana O'Brien (Biotechnology Innovation Organization);

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

No Significant Event

Official Name: Rebecca K. Wood, J.D., Chief Counsel

No Significant Event