CDER Conversations
Discussions with key Center for Drug Evaluation and Research (CDER) leadership about important regulatory and policy issues
The Latest CDER Conversations
CDER Launches a Center for Clinical Trial Innovation
Kevin Bugin, PhD, lead for C3TI and deputy director of operations in the Office of New Drugs (OND), explains the purpose of C3TI, the importance of clinical trial innovation, and ways in which C3TI can advance public health.
Understanding CDER’s Postmarket Safety Surveillance Programs and Public Data
Gerald J. Dal Pan, M.D., M.H.S., Director of CDER’s Office of Surveillance and Epidemiology (OSE), discusses current priorities to develop and implement processes needed to support efficient and effective postmarket safety.
Setting and Implementing Standards for Narrow Therapeutic Index Drugs
Our experts discuss how CDER helps ensure the dosage range of narrow therapeutic index (NTI) drugs falls within a safe and effective therapeutic window, and the challenges and opportunities in developing NTI generic drugs.
Optimizing Drug Information Through Target Audience Feedback
Alexandria Smith, MSPH, a social scientist with CDER's Research and Risk Communications staff, discusses how our communications testing program helps ensure the information we share is understandable, relevant, trustworthy, and useful.
All CDER Conversations
2024
- CDER Launches a Center for Clinical Trial Innovation
- 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
- 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)