Publication Archive

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Government Capacity
day one project
Policy Memo
Protecting Infant Nutrition Security:
Shifting the Paradigm on Breastfeeding to Build a Healthier Future for all Americans

Policymakers on both sides of the aisle agree that no baby should ever go hungry, as evidenced by the bipartisan passage of recent breastfeeding legislation and widely supported regulations. However, significant barriers remain.

02.11.25 | 10 min read
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Emerging Technology
day one project
Policy Memo
Clearing the Path for New Uses for Generic Drugs

To encourage greater adoption of generic drugs in clinical practice the FDA should implement a dedicated regulatory pathway for non-manufacturers to seek approval of new indications for repurposed generic drugs.

01.09.25 | 16 min read
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Emerging Technology
day one project
Policy Memo
Slow Aging, Extend Healthy Life: New incentives to lower the late-life disease burden through the discovery, validation, and approval of biomarkers and surrogate endpoints

New solutions are needed to target diseases before they are life-threatening or debilitating, moving from retroactive sick-care towards preventative healthcare.  

12.09.24 | 15 min read
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Emerging Technology
day one project
Policy Memo
The Medicare Advance Healthcare Directive Enrollment (MAHDE) Initiative: Supporting Advance Care Planning for Older Medicare Beneficiaries

At least 40% of Medicare beneficiaries do not have a documented AHCD. In the absence of one, medical professionals may perform major and costly interventions unknowingly against a patient’s wishes. 

12.02.24 | 14 min read
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Emerging Technology
day one project
Policy Memo
Driving Equitable Healthcare Innovations through an AI for Medicaid (AIM) Initiative

AI has transformative potential in the public health space, but innovation driven primarily by the private sector today may be exacerbating existing disparities by training models.

12.02.24 | 6 min read
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Emerging Technology
day one project
Policy Memo
Promoting Fairness in Medical Innovation

The incoming administration must act to address bias in medical technology at the development, testing and regulation, and market-deployment and evaluation phases.

11.22.24 | 16 min read
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Emerging Technology
day one project
Policy Memo
Establish Data Standards To Protect Newborn DNA Privacy by Developing Data Storage Standards for Newborn Screening Samples

The incoming administration should work towards encouraging state health departments to develop clear and well-communicated data storage standards for newborn screening samples.

11.18.24 | 11 min read
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Government Capacity
Report
Improving Public Awareness and Understanding of Advisory Committees

Improving public awareness of FDA Advisory Committees would improve public trust and deter misinformation related to the approval of medical products.

09.13.24 | 4 min read
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Government Capacity
Report
The Role of Patient Advocacy in the AdComm Process

The absence of consistent voting privileges for patient representatives on Advisory Committees hinders representatives from providing an voice on behalf of the community they represent.

09.12.24 | 7 min read
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Government Capacity
Report
FDA Staff and Leadership Disagreements and the Role of the AdComm in the Regulatory Process

Internal disagreements present a growing concern about FDA leadership overruling the expert opinions of scientific staff and proceeding with official approvals, thus undermining staff expertise, decreasing agency morale, and potentially diminishing public trust.

09.10.24 | 6 min read
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Government Capacity
Report
Leveraging AdComm Membership

AdComm members note a lack of transparency in recruitment methods, insufficient training, and limited understanding of regulatory procedures.

09.09.24 | 8 min read
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Government Capacity
Report
The Future of Voting for FDA Advisory Committees

Public meetings led by FDA Advisory Committees are instrumental in facilitating transparent deliberation between the FDA, the advisory body, and the American public.

09.09.24 | 4 min read
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