Nancy Smith, PhD, retired from CDER/FDA in 2009 after over 21 years. Nancy is past-Chair of the Biopharmaceutical Section of the American Statistical Association, and served as a DIA board member of from 2002-2008. She is currently an ORISE Fellow at FDA developing training for new reviewers.
Thomas Abrams is the Director of the Office of Prescription Drug Promotion (OPDP), Food and Drug Administration. Before becoming Director of OPDP, Mr. Abrams was Director of the Division of Drug Marketing, Advertising, and Communications.
Dr. Jenkins is Board Certified in Internal Medicine and Pulmonary Diseases by the American Board of Internal Medicine. He joined FDA in 1992 and has been Director of the Office of New Drugs since 2002.
Justina is a pharmacist and attorney, and a commissioned officer in the U.S Public Health Service. She is currently the Associate Director for International Programs, CDER/USFDA One of her primary responsibilities is coordination of CDER’s efforts related to the ICH.
Dr. Temple is Deputy Center Director for Clinical Science of FDA’s Center for Drug Evaluation and Research and is Acting Director of the Office of Drug Evaluation I, which is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products.
JULIE ZAWISZA (Zah-Veeshah) Is the Director of CDER’s Office of Communications and has also served as FDA’s acting and Assistant Commissioner for Public Affairs.
He received his medical degree from Columbia University, and his Master's degree in clinical epidemiology from Johns Hopkins. He trained in Internal Medicine at the Hospital of the Univ of Pennsylvania, and in Neurology at Johns Hopkins. He is board certified in Internal Medicine and Neurology.
Description
Part 2 of this forum will take place on Thursday, June 28th at 10:45 am. The leadership team of CDER will be invited to participate in this forum. The topics that will be discussed will depend on the audience and on areas that are of current importance within the CDER community. Submit your questions in advance to annualmeetingprogram@diahome.org Subject:CDER Town Hall.
Learning Objectives: Summarize key issues discussed by CDER Discuss regulatory hot topics.