The Haystack Project
  • Home
  • About Us Participants Partners Board and Advisors
  • Priorities
  • PROTECT Rare
  • Rare Disease Approvals HEART Act
  • Speaker Series Payer Engagement Health Equity Rare Cancer
  • Inflation Reduction Act Medicare Section 340b Medicaid FDA ICER
  • Patient Stories
  • Join
  • Take Action
The Haystack Project
  • Home/
  • About/
    • About Us
    • Participants
    • Partners
    • Board and Advisors
  • Priorities/
  • PROTECT Rare/
  • FDA/
    • Rare Disease Approvals
    • HEART Act
  • Programs/
    • Speaker Series
    • Payer Engagement
    • Health Equity
    • Rare Cancer
  • Policy/Comments/
    • Inflation Reduction Act
    • Medicare
    • Section 340b
    • Medicaid
    • FDA
    • ICER
  • Patient Stories/
  • Join/
  • Take Action/
Blue-Banner.png
The Haystack Project

FDA

The Haystack Project
  • Home/
  • About/
    • About Us
    • Participants
    • Partners
    • Board and Advisors
  • Priorities/
  • PROTECT Rare/
  • FDA/
    • Rare Disease Approvals
    • HEART Act
  • Programs/
    • Speaker Series
    • Payer Engagement
    • Health Equity
    • Rare Cancer
  • Policy/Comments/
    • Inflation Reduction Act
    • Medicare
    • Section 340b
    • Medicaid
    • FDA
    • ICER
  • Patient Stories/
  • Join/
  • Take Action/
Featured
Newborn Screening Coalition Letter
May 9, 2025
Newborn Screening Coalition Letter
May 9, 2025
May 9, 2025
US FDA’s Makary Floats Vague ‘Plausible Mechanism’ Approval Pathway For Rare Diseases
Apr 22, 2025
US FDA’s Makary Floats Vague ‘Plausible Mechanism’ Approval Pathway For Rare Diseases
Apr 22, 2025
Apr 22, 2025
Makary Pitches Rare Disease Approvals Based On ‘Plausible Mechanism’
Apr 22, 2025
Makary Pitches Rare Disease Approvals Based On ‘Plausible Mechanism’
Apr 22, 2025
Apr 22, 2025
Pink Sheet: Woodcock Warns of ‘Excessive Worship Of The RCT,’ Pushes New Drug Approval Pathway
Nov 13, 2024
Pink Sheet: Woodcock Warns of ‘Excessive Worship Of The RCT,’ Pushes New Drug Approval Pathway
Nov 13, 2024
Nov 13, 2024
Pink Sheet: Woodcock Throws Weight Behind Push For New Legislative ‘Substantial Evidence’ Standard For Rare Disease Drugs
Oct 29, 2024
Pink Sheet: Woodcock Throws Weight Behind Push For New Legislative ‘Substantial Evidence’ Standard For Rare Disease Drugs
Oct 29, 2024
Oct 29, 2024
Inside Health Policy: Haystack Project Working With Lawmakers On Rare Disease Approval Legislation
Oct 28, 2024
Inside Health Policy: Haystack Project Working With Lawmakers On Rare Disease Approval Legislation
Oct 28, 2024
Oct 28, 2024
BioCentury: Perspective: A path forward for rare disease policy
Oct 25, 2024
BioCentury: Perspective: A path forward for rare disease policy
Oct 25, 2024
Oct 25, 2024
Inside Health Policy: Woodcock: RCT Standards Not Fit For Rare Disease Treatment Approval
Oct 23, 2024
Inside Health Policy: Woodcock: RCT Standards Not Fit For Rare Disease Treatment Approval
Oct 23, 2024
Oct 23, 2024
Pink Sheet: Clinical Trial Diversity Action Plans Need Timely US FDA Feedback, Groups Say
Oct 7, 2024
Pink Sheet: Clinical Trial Diversity Action Plans Need Timely US FDA Feedback, Groups Say
Oct 7, 2024
Oct 7, 2024
Haystack FDA DAP Guidance Comment 9.26.24
Sep 26, 2024
Haystack FDA DAP Guidance Comment 9.26.24
Sep 26, 2024
Sep 26, 2024

 
 
  • Home/
  • About/
    • About Us
    • Participants
    • Partners
    • Board and Advisors
  • Priorities/
  • PROTECT Rare/
  • FDA/
    • Rare Disease Approvals
    • HEART Act
  • Programs/
    • Speaker Series
    • Payer Engagement
    • Health Equity
    • Rare Cancer
  • Policy/Comments/
    • Inflation Reduction Act
    • Medicare
    • Section 340b
    • Medicaid
    • FDA
    • ICER
  • Patient Stories/
  • Join/
  • Take Action/

The Haystack Project

Act Now

Engage in our efforts to support Ultra Rare advocacy.

Act Now
 

Join Haystack Project

Get news and updates and engage in Ultra Rare advocacy. Sign up to join our community today.

Join Us
 

Keep up-to-date with current events at Haystack!

View past newsletters

About Us

The Issues

Resources

News & Updates

© 2020 Haystack Project. All Rights Reserved. 

 

Contact Us

Please consider making a tax-deductible donation to support the Haystack Project today.

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.