Medical Product Development and Regulatory Policy
Projects Relating to Medical Product Development and Regulatory Policy
Project
Rare Disease Innovation, Science, and Exploration (RISE) Workshop Series
The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the U.S. FDA, is co-convening the Rare Disease Innovation, Science, and Exploration (RISE) Workshop series with the Rare Disease Innovation Hub. With many rare diseases lacking approved therapies these patient populations face unique challenges to medical product development, including small patient populations,...
The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the U.S. FDA, is...
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Project
Duke-Margolis ReVAMP Drug Supply Chain Consortium
Reliable drug supply, Valuing availability, Advanced Manufacturing Technologies, and Patient-Center Focus (ReVAMP) The Consortium’s mission is to identify effective policy solutions that promote a resilient drug supply chain with advanced manufacturing capabilities and, ultimately, reduce the frequency and severity of drug shortages. Based on input from a wide range of experts involved in...
Reliable drug supply, Valuing availability, Advanced Manufacturing Technologies, and Patient-Center...
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Project
Artificial Intelligence in Health Care Portfolio
Duke-Margolis AI researchers are devoted to harnessing the potential of safe, trustworthy, and responsible AI to transform health care
Duke-Margolis AI researchers are devoted to harnessing the potential of safe, trustworthy, and...
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Related Work
Manufacturing quality issues, public health emergencies, natural disasters, bioterrorism, geopolitical issues, and other supply and demand shocks all pose threats to patients in need of uninterrupted access to life-saving essential drugs. Duke-Margolis developed the ReVAMP Drug Supply Chain Consortium to generate effective policy solutions that promote a reliable drug supply chain.
More information:
Emerging Initiatives - Duke-Margolis Cell and Gene Policy Initiative and Enabling the Digital Health Revolution
Project Page - Duke-Margolis ReVAMP Drug Supply Chain Consortium
Click here for more information on our work with the U.S. Food and Drug Administration
Manufacturing quality issues, public health emergencies, natural disasters, bioterrorism, geopolitical issues, and other supply and demand shocks all pose threats to patients in need of uninterrupted access to life-saving essential drugs. Duke-Margolis developed the ReVAMP Drug Supply Chain Consortium to generate effective policy solutions that promote a reliable drug supply chain.
More information:
Emerging Initiatives - Duke-Margolis Cell and Gene Policy Initiative and Enabling the Digital Health Revolution
Project Page - Duke-Margolis ReVAMP Drug Supply Chain Consortium
Events About Medical Product Development and Regulatory Policy
More EventsEvent 4/23/2026
Increasing Access to Nonprescription Drugs
This hybrid public meeting, convened by the Duke-Margolis Institute for Health Policy under a…
Read MoreEvent 5/29/2025
Generic Drug Repurposing: Exploring the Potential Role of the Regulator and Policy Solutions
WASHINGTON, DC
This hybrid workshop will provide a forum for participants to discuss the potential role of the…
Read MorePublications About Medical Product Development and Regulatory Policy
More PublicationsPolicy Brief
Modernizing Influenza Vaccine Development: Policy Priorities for Stakeholders
Brian Canter, Nancy Allen LaPointe, Coralei Neighbors, Molly Shields
Brian Canter, Nancy Allen LaPointe, Coralei Neighbors, Molly Shields
2026
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From Concept to Policy: Pull Funding for Repurposed Generic Drugs
Beth Boyer, Sarrin Chethik, Mia Williams
Beth Boyer, Sarrin Chethik, Mia Williams
2025
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Barriers and Solutions Across Drug Repurposing Archetypes
Noelle Harada, Beth Boyer, David Fajgenbaum, Tanisha Carino
Noelle Harada, Beth Boyer, David Fajgenbaum, Tanisha Carino
2025
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Regulatory Opportunities to Advance Generic Drug Repurposing
Mia Williams, Beth Boyer, Tanisha Carino
Mia Williams, Beth Boyer, Tanisha Carino
2025
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