CDER Conversations
Discussions with key CDER leadership about important regulatory and policy issues
The Latest CDER Conversations
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.
Opportunities to Enhance Safe and Effective Medication Use
The Office of Medical Policy’s Evan Wearne, PharmD, MS, explains the role that software may play in promoting safe and effective drug use and the future interplay between software and therapeutics.
Creating Harmonized Technical Standards Through Guidelines
Theresa Mullin, PhD, Associate Center Director for CDER’s Strategic Initiatives, talks about CDER’s important work as a Founding Regulatory Member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
All CDER Conversations
2024
- 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)