CDER Conversations
Discussions with key Center for Drug Evaluation and Research (CDER) leadership about important regulatory and policy issues
Latest CDER Conversations
Commemorating the 15th Anniversary of the Biologics Price Competition and Innovation Act
Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars (OTBB) in CDER’s Office of New Drugs, discusses how the BPCIA has impacted public health, biologics manufacturing, and the future of biosimilars.
40th Anniversary of the Generic Drug Approval Pathway
Darby Kozak, PhD, deputy director for CDER’s Office of Generic Drugs, talks about the impact of the Hatch-Waxman Amendments on the generic drug industry, FDA’s work, and patients and consumers.
Streamlining Drug Development and Improving Patient Care: CDER Quantitative Medicine Center of Excellence
Rajanikanth Madabushi, lead for the QM CoE and associate director for Guidance and Scientific Policy in the Office of Clinical Pharmacology in the Office of Translational Science Super Office explains the purpose of the new CoE, provides an overview of current activities and resources, and shares ways the CoE can advance drug development and improve patient care.
Modernizing the New Drugs Regulatory Program
Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs (OND), discusses the modernization, its accomplishments, and its impact on public health. A comprehensive list of the achievements is available in the NDRP Modernization - Impact Narrative 2023 .
CDER’s Emerging Drug Safety Technology Meeting Program
Robert Ball, M.D., M.P.H., ScM, Deputy Director of CDER’s Office of Surveillance and Epidemiology, explains the EDSTM program and the application of AI in PV based on his experience of more than a decade researching and developing AI systems in PV.
More CDER Conversations
2024
- 40th Anniversary of the Generic Drug Approval Pathway
- Streamlining Drug Development and Improving Patient Care: CDER Quantitative Medicine Center of Excellence
- Modernizing the New Drugs Regulatory Program
- CDER’s Emerging Drug Safety Technology Meeting Program
- CDER Launches a Center for Clinical Trial Innovation
- Patient Medication Information: A 2023 Proposed Rule to Help Patients Understand Their Prescription Medication Information
- Understanding CDER’s Postmarket Safety Surveillance Programs and Public Data
- Setting and Implementing Standards for Narrow Therapeutic Index Drugs
- CDER Communications Testing: Optimizing Drug Information Through Target Audience Feedback
View archived CDER Conversations (2020-2023) View archived CDER Conversations (2014-2019)