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.
All 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
2023
- Software Associated with Prescription Drugs: Opportunities to Enhance Safe and Effective Medication Use
- FDA works through ICH to Support Global Drug Development: Creating Harmonized Technical Standards Through Guidelines
- Improving Medication Adherence and Patient Experience by Researching Patient Perceptions of Generic Drugs
- CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality
- Ensuring the Safety of FDA-Approved Generic Drugs
- The Evolving Role of Decentralized Clinical Trials and Digital Health Technologies
- The Office of New Drugs' Efforts to Expand Regulatory Science Research
- Using Innovative Communication Methods to Increase Awareness and Understanding of CDER Guidance Documents: CDER’s Guidance Snapshot Pilot Program
- The Latest in Drug Shortages
- Biosimilar User Fee Amendments Latest Implementation: BsUFA III
2022
- FDA’s Final Guidance on Carcinogenicity Testing of Pharmaceuticals
- OGD Global Affairs Program, One Year Progress Report of Generic Drug Cluster
- CDER’s Drug Quality Sampling and Testing Program
- Information Visualization Platform (InfoViP): CDER’s New Artificial Intelligence Safety Surveillance Tool
- FDA Updates on Paxlovid for Health Care Providers
- Disclosing Information About Drugs and Fostering CDER’s Transparency Efforts
- The Generic Drug Approval Process
- OPDP’s Social Science Research Program: Aiming to Understand How Health Care Providers and Patients Interpret Prescription Drug Information
2021
- CDER Creates New Biologics Resources for Educators, Teaching Facilities
- Novel Excipient Review Pilot Program
- An Update on Sunscreen Requirements: The Deemed Final Order and the Proposed Order
- Crowdsourcing Pediatric Regulatory Science Research Question
- OPDP Reflects on 2020, Looks Forward to 2021 as It Helps Ensure Prescription Drug Promotion Is Truthful, Balanced and Accurate
2020
- Patents and Exclusivities for Generic Drug Products
- CDER Focuses on Novel Drug Development Tools to Help Speed Creation of New Therapies
- Reflecting on Biosimilar User Fee Amendments (BsUFA) II and preparing for the BsUFA III reauthorization process
- CDER’s Efforts to Help Improve the Quality of Drug Compounding Include an Ongoing Focus on Insanitary Conditions
- Building on Successes of the Generic Drug Program, FDA Sets the Stage for the Next Generic Drug User Fee Amendments (GDUFA) Reauthorization Process
- New Funding Opportunity: FDA Standard Core Clinical Outcome Assessments (COAs) and Endpoints Pilot Grant Program
- Real World Evidence - From Safety to a Potential Tool for Advancing Innovative Ways to Develop New Medical Therapies
View archived CDER Conversations (2014-2019)