Bringing Regulators & the Regulated Together: DIAmond Session 412: CDER Town Hall

Each DIA Annual Meeting features an extended, live Q&A session with senior leadership from the FDA Center for Drug Evaluation & Research. Highlights of the interactive CDER Town Hall held at DIA2016 included: Dr. Richard Pazdur, acting leader of the FDA's Office of Excellence in Oncology, will help establish this program to develop consistent policies/practices for oncology products across all FDA review centers; the package of proposed industry-FDA recommendations for reauthorization of PDUFA is in Obama Administration review; and FDA continues to work closely with China, the world's second largest pharmaceutical market, to help establish quality standards for the drug supply chain. Moderator: Nancy D. Smith, PhD, FDA Alumni. Featured Speakers: Leah Christl, PhD, Associate Director for Therapeutic Biologics, TBBS, OND; Gerald J. Dal Pan, MD, Director, Office of Surveillance and Epidemiology; John Jenkins, MD, Director, Office of New Drugs; Michael Kopcha, PhD, RPh, Director, Office of Pharmaceutical Quality; Theresa M. Mullin, PhD, Director, Office of Strategic Programs; and Lynne Yao, MD, Acting Director, Pediatric and Maternal Health Staff, OND.