Public Calendar: August 19-25, 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
No Significant Event
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: 08/20/2018
Location: Bethesda, MD
Subject: The Growing Promise of Gene Therapy Approaches to Rare Diseases Workshop
FDA Participant/Group: WILSON BRYAN; CHEAUYUN CHEN; TEJASHRI PUROHIT-SHETH; DENISE GAVIN; IWEN WU; ANDREW BYRNES;
Non FDA Participant/Group: Leonela Amoasii (The University of Texas Southwestern Medical Center ); Anne Pariser, Charles Venditti, Christopher Austin, Harry Malech, John Chiorini, Stephen Kaler (National Institutes of Health); Jaysson Eicholtz, Jerry Mendell (Nationwide Children's Hospital); Reed Clark (Ultragenyx Pharmaceutical); Josh Grieger (Asklepios BioPharmaceutical Incorporated); Barry Byrne (University of Florida Health); Ken Cornetta (Indiana University School of Medicine); Doug Martin (Auburn University); Richard Jude Samulski (University of North Carolina School of Medicine); Richard Snyder (Brammer); Florian Eichler (Harvard Medical School); Chester Whitley (University of Minnesota);
Official Name: Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health
No Significant Event
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: Lowell Schiller, J.D., Acting Chief Counsel
Event Date: 08/23/2018
Location: Silver Spring, MD
Subject: Issues Related to Guidance on Pharmaceutical Stability
FDA Participant/Group: ELIZABETH DICKINSON; JENNIFER KANG; ANNAMARIE KEMPIC; KEVIN MAGUIRE; SARA BEARDSLEY; FRANCIS GODWIN; CLAUDIA ZUCKERMAN; JANICE BROWN;
Non FDA Participant/Group: Gerardo Mendez, Jeff Tabatabai, Jerry Roth, Larry Roth (Hill Dermaceuticals Incorporated); Sheldon Bradshaw (King & Spalding LLP);