DIA: Driving Insights to Action
Science:Life Sciences
As the Director of CDER's Office of Generic Drugs' Clinical Safety Surveillance Staff, Dr. Howard Chazin leads a multidisciplinary team of pharmacists, medical officers and data analysts to identify and assess emerging complex safety issues related to generic drugs. “Generic drugs provide considerable cost savings. They also enhance the availability of quality medications to the American public,” he explains. “The American public should have confidence in generic drugs.”
Advancing the Science of Study Endpoints
Analyzing Innovation’s Progress in Gottlieb Era
Comparing Generic Safety Profile with Branded Cousin
Defining Unmet Need Critical to Determining Value
Triple-A RWE: Adequate Data, Appropriate Designs, Actionable Evidence
US REMS Requirements for NDAs and BLAs
Epoietin Biosimilars: Qualitative Study of Patients' Views
Disparities Between FDA/EMA Review Processes
DIA Japan's Focus in Fall 2018
FDA Leadership on Future Biologics and EMA/FDA Cooperation
Global Perspectives on Patient Engagement
DIA Board Chair Discusses DIA Now and Digital Tomorrow
Integrating Genetic Medicine into Clinical Care
Regulatory Landscape of Drug-Device Combination Products
Value-Based Assessment & Contracting: What Needs to Be Done?
Block Chain, AI, Internet of Things: Future of PharmaTech?
“My Voice Needed to Be Heard”
IMEDS Collaboration Builds Upon Sentinel Surveillance
Crafting Sound Medical Affairs Professionals
Statistical Strategies for Using Sources of Safety Data
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