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Featured
Press Release the FDA Initiative 10.13.26
October 14, 2026
Press Release the FDA Initiative 10.13.26
October 14, 2026
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October 14, 2026
FDA Substantial Evidence Draft Guidance Met With Opposition From Consumer Group
October 2, 2026
FDA Substantial Evidence Draft Guidance Met With Opposition From Consumer Group
October 2, 2026
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October 2, 2026
Haystack Substantial Evidence 9.22.26
September 22, 2026
Haystack Substantial Evidence 9.22.26
September 22, 2026
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September 22, 2026
Gene-Silencing Therapies Face Different Bar Under US FDA Plausible Mechanism Framework
September 16, 2026
Gene-Silencing Therapies Face Different Bar Under US FDA Plausible Mechanism Framework
September 16, 2026
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September 16, 2026
Haystack Project- FDA, CMS Statute Changes Needed Before Drug Repurposing
August 27, 2026
Haystack Project- FDA, CMS Statute Changes Needed Before Drug Repurposing
August 27, 2026
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August 27, 2026
Auchincloss Leg Specs Feedback 7.6.26
July 6, 2026
Auchincloss Leg Specs Feedback 7.6.26
July 6, 2026
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July 6, 2026
Plausible Mechanism Pathway Comments
May 19, 2026
Plausible Mechanism Pathway Comments
May 19, 2026
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May 19, 2026
PRESS RELEASE: Haystack Project Files Petition for Rulemaking to Establish Context-Based Evidence Framework for Rare Diseases
April 9, 2026
PRESS RELEASE: Haystack Project Files Petition for Rulemaking to Establish Context-Based Evidence Framework for Rare Diseases
April 9, 2026
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April 9, 2026
Haystack Project Petitions FDA To Adopt Context-Driven Evidence Approach For Rare Therapies
April 9, 2026
Haystack Project Petitions FDA To Adopt Context-Driven Evidence Approach For Rare Therapies
April 9, 2026
Read more →
April 9, 2026
Haystack Project’s Petition for Rulemaking
April 2, 2026
Haystack Project’s Petition for Rulemaking
April 2, 2026
Read more →
April 2, 2026

 
 
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    • Section 340b
    • Medicaid
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    • ICER
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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.