More CDER Conversations
2022
- FDA Updates on Paxlovid for Health Care Providers
- Disclosing Information About Drugs and Fostering CDER’s Transparency Efforts
- The Generic Drug Approval Process (Updated)
- OPDP’s Social Science Research Program: Aiming to Understand How Health Care Providers and Patients Interpret Prescription Drug Information
2021
- CDER Conversation: 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
2019
- Safe Use of Medicine Relies on Strong Research with Scott Winiecki
- FDA’s Clinical Outcome Assessment Compendium with Elektra Papadopoulos
- Ensuring That Standardization Does Not Impede Biological Product Innovation with Steven Kozlowski
- Tracking and Acting on Safety Data Throughout a Drug’s Lifecycle with Gerald Dal Pan
- Assuring Drug Quality Around the Globe with Donald D. Ashley and Michael Kopcha
2018
- Monitoring Social Media to Better Understand Drug Use Trends with Paula Rausch
- Safely Using the Newly Available OTC Asthma Inhaler Primatene Mist with Theresa Michele
- Complex Innovative Trial Designs with Dionne Price
- Treatment for Opioid Use Disorder with Mitra Ahadpour
- Advancing the Development of Treatments for Neurological Disorders with Billy Dunn
- Model Informed Drug Development with Raj Madabushi
- Reducing the Risk of Loperamide Misuse and Abuse with Dr. Theresa M. Michele
2017
- The Generic Drug Approval Process 11/20/2017 (Archived)
- The FDA's Sentinel Initiative with Dr. Robert Ball
- Evaluating the Risk of Drug-Drug Interactions with Issam Zineh
- Measuring the Impact of Opioid Analgesic Formulations with Properties Designed to Deter Abuse in the Real World with Dr. Judy Staffa
- Patents and Exclusivities for Generic Drug Products with Capt. Martin Shimer
- Understanding the Influence of Prescription Drug Advertising with Kathryn Aikin
2016
- Studying how pathogens cause disease with Daniela Verthelyi
- How Do Clinical Holds Impact Drug Development Programs, with Larissa Lapteva, M.D.
- The Generic Drug Approval Process with Ted Sherwood
- Bleeding Risk from Antacids that Contain Aspirin, with Dr. Karen Mahoney
- FDA's Breakthrough Therapy Designation with Dr. Richard Moscicki
- FDA's Expedited Review Programs with Dr. Richard Moscicki
2015
- Safe medicine disposal options with Dr. Douglas Throckmorton
- CDER's Drug Safety Communications with Dr. Sheilyn Huang
- Pediatric pain management with Dr. Sharon Hertz
- FDA's drug shortages prevention strategies with CDR Emily Thakur