The Haystack Project is a 501(c)3 nonprofit that brings together patients organizations representing patients suffering from or caring for patients with extremely rare diseases. Our mission is to educate policymakers and other stakeholders about the need for policies that recognize the unique circumstances of extremely rare conditions and treatments and expand incentives critical to ensuring they can reach patients.

Resources

US FDA’s Makary Floats Vague ‘Plausible Mechanism’ Approval Pathway For Rare Diseases→

Makary Pitches Rare Disease Approvals Based On ‘Plausible Mechanism’→

Pink Sheet: Woodcock Warns of ‘Excessive Worship Of The RCT,’ Pushes New Drug Approval Pathway→

Pink Sheet: Woodcock Throws Weight Behind Push For New Legislative ‘Substantial Evidence’ Standard For Rare Disease Drugs→

Inside Health Policy: Haystack Project Working With Lawmakers On Rare Disease Approval Legislation→

BioCentury: Perspective: A path forward for rare disease policy→

Inside Health Policy: Woodcock: RCT Standards Not Fit For Rare Disease Treatment Approval→

Pink Sheet: Clinical Trial Diversity Action Plans Need Timely US FDA Feedback, Groups Say→

FDA gets pointed input on ‘optimizing’ advisory committee panels→

Pink Sheet: Woodcock Takes On Rare Disease Challenges In Retirement, Keeps FDA, Industry At Arm’s Length→

Pink Sheet: FDA Looking To Boost Transparency On How Patient Input Is Used In Drug Reviews→

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