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  1. News & Events for Human Drugs

CDER Conversations

Discussions with key Center for Drug Evaluation and Research (CDER) leadership about important regulatory and policy issues

Latest CDER Conversations

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Photo of Sarah Yim

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.

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OGD Deputy Director Darby Kozak discusses the impact of the Hatch-Waxman Amendments on the generic drug industry, FDA’s work, and patients and consumers.

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.

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CDER Conversation Rajanikanth Madabushi

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.

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CDER Conversation Banner with photograph of Yoni Tyberg

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 .

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Image of Robert Ball.

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.

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2020

View archived CDER Conversations (2014-2019)



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