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: 06/18/2018
Location: Bethesda, MD
Subject: FDA's Nicotine and Tobacco Regulation and the Key Role of Regulatory Science
FDA Participant/Group: Mcwilliams, Carlyle S;
Non FDA Participant/Group: Government, industry, and other invited participants

Event Date: 06/19/2018
Location: Silver Spring, MD
Subject: National Association of State Departments of Agriculture Meeting
FDA Participant/Group: Silvis, Lauren R; Farrar, Jeffrey A; Solomon, Steven M; Mcwilliams, Carlyle S; Roth, Lauren K; Rogers, Michael R; Plaisier, Melinda K; Mayne, Susan T; Abram, Anna K; Ostroff, Stephen M; Chukwudebe, Nnaemeka R; Boon, Caitlin S; Mettler, Erik P; Cassens, Barbara J; Wood, Rebecca H; Tropea, Josephine M; Beckerman, Peter C;
Non FDA Participant/Group: Gary W. Black (Georgia Department of Agriculture); Jennifer Trodden (New York State Department of Agriculture and Markets ); Richard Ball (New York State Department of Agriculture and Markets); Barbara Glenn, Bob Ehart, Janell Hendren, Nathan Bowen (National Association of State Departments of Agriculture); Joe Reardon, Laura Kilian, Steve Troxler, Zane Hedgecock (North Carolina Department of Agriculture and Consumer Services); Don Brown (Colorado Department of Agriculture);

Event Date: 06/21/2018
Location: Silver Spring, MD
Subject: Biosimilars for the American Patient Population
FDA Participant/Group: Franklin, Joseph B; Christl, Leah A; Toufanian, Maryll W; Moran, Kristine M; Roth, Lauren K; Sipes, Grail W; Dickinson, Elizabeth H; Silvis, Lauren R; Abram, Anna K;
Non FDA Participant/Group: Chester Davis, Christine Simmon, David Gaugh, Rachel Sher (Association for Accessible Medicines); Robert Stewart (Amneal Incorporated); Jeff Watson (Apotex Incorporated); Carol Lynch (Sandoz Incorporated); Heather Bresch (Mylan N.V.);

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

Event Date: 06/18/2018
Location: Brussels, Belguim
Subject: European Medicines Agency Bilateral Meeting
FDA Participant/Group: Mullin, Theresa M; Scherer, Matthew C; Kweder, Sandra L; Valdez, Mary lou; Mciff, Colin L; Marks, Peter W; Laska, Susan F;
Non FDA Participant/Group: Several officials from the European Medicines Agency

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

Event Date: 06/21/2018
Location: College Park, MD
Subject: Safe Food Coalition Meeting: Food Safety Modernization Act
FDA Participant/Group: Waldrop, Christopher A; Irvin, Kari A; Correll, William A; Howard king, Vinetta M; Stearn, Douglas W; Gorny, James R; Thomas, Jennifer A; Rogers, Michael C; Carlson, Jan; Shapinsky, David F; Prater, Donald A; Robbs, Janesia R; Mayne, Susan T;
Non FDA Participant/Group: Several members from the Pew Charitable Trusts

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

Event Date: 06/21/2018
Location: Washington, DC
Subject: Association of Clinical Research Organizations Board of Directors Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

Event Date: 06/21/2018
Location: Washington, DC
Subject: Consumer Health Products Association Board Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

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

Event Date: 06/22/2018
Location: Silver Spring, MD
Subject: Regenerative Medicine Advanced Therapies and Regulatory Innovation
FDA Participant/Group: N/A
Non FDA Participant/Group: Several members from the Research!America Organization

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

Event Date: 06/19/2018
Location: Silver Spring, MD
Subject: General Medical Device Updates
FDA Participant/Group: Saha, Anindita; Dumont, Douglas M; Tarver, Michelle E; O callaghan, Kathryn;
Non FDA Participant/Group: Jijo James, Joanne Waldstreicher, Michelle McMurry-Heath, Philip Desjardins (Johnson & Johnson Services Incorporated);

Event Date: 06/20/2018
Location: San Francisco, CA
Subject: Rosenman Institute Symposium: Reimagining the Medical Device Oversight Paradigm
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

Event Date: 06/22/2018
Location: Silver Spring, MD
Subject: Warning Letters Appeal Meeting
FDA Participant/Group: Kiang, Tina; Fischer, Carl; Maisel, William H; Moore, Kira L; Payne, Erica B; Green, Sheena A; Victoria, Nicole C; Crusan, Annabelle; Faris, Owen P; Godfrey, Linda D; Calvin, Veronica J; Pittman, Eric S; Miller, Natalie J; Blakely, Brandon L; Pamidimukkala, Geeta K; Katz, Elizabeth J; Lee, James J; Johnson, Antionette N; Flores, Krista N; Davis, Judith; Desta, Abiy B;
Non FDA Participant/Group: Jack Risdahl, Jacqueline Torfin, Jean Pierre Boutrand, Joe Carraway, John Gorski (North American Science Associates Incorporated);

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

No Significant Event