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In The Media STAT News

FDA Review Staff was Excluded from Voting on Whether to Approve First Priority Voucher Drug

Interview

Featured Fellow:
  • Holly Fernandez Lynch, JD, MBE
November 21, 2025
Four pills sitting on top of a magnifying glass with a clock in the background.

In Their Own Words

These Patients Have Nothing Else. Should That Be Enough for FDA Drug Approval?

Despite Streamlined Processes, FDA’s Role in Rare-Disease Drug Development Draws Continued Scrutiny

By:
  • Holly Fernandez Lynch, JD, MBE
  • and Remsha Ramachandran, MD, MPP, MHS
October 21, 2025

In The Media The New York Times

How Private Equity Oversees the Ethics of Drug Research

Interview

Featured Fellow:
  • Holly Fernandez Lynch, JD, MBE
October 4, 2025

In The Media KFF Health News

Under Trump, FDA Seeks To Abandon Expert Reviews of New Drugs

Interview

Featured Fellow:
  • Holly Fernandez Lynch, JD, MBE
September 12, 2025

In The Media Bloomberg

Right to Try Movement Finds Powerful Allies Under Trump

Interview

Featured Fellow:
  • Holly Fernandez Lynch, JD, MBE
August 19, 2025

In The Media Bloomberg

How the Moms and Dads of Patients Won Sarepta’s Drug a Reprieve

Interview

Featured Fellow:
  • Holly Fernandez Lynch, JD, MBE
August 18, 2025

Policy

Policy Recommendations for Strengthening the Accelerated Approval Program for Oncology Drugs

Memo: Delivered to the U.S. Food and Drug Administration (FDA)

By:
  • Holly Fernandez Lynch, JD, MBE
  • Steven Joffe, MD, MPH
July 15, 2025

In The Media The Guardian

Patients with Ultra-Rare Diseases Worry FDA Approach Will Leave Them Without Treatment

Interview

Featured Fellow:
  • Holly Fernandez Lynch, JD, MBE
July 6, 2025

In The Media Medpage Today

How Fast Is Too Fast for FDA Drug Review?

Author

Featured Fellow:
  • Holly Fernandez Lynch, JD, MBE
June 25, 2025

In The Media Bloomberg

FDA Appointee Is A Drug Critic With A Lot To Prove

Interview

Featured Fellow:
  • Holly Fernandez Lynch, JD, MBE
May 15, 2025

In The Media Politico

Where Drug Ingredients Are Made

Interview

Featured Fellow:
  • Holly Fernandez Lynch, JD, MBE
April 29, 2025

In The Media STAT News

‘We’re Living In The Twilight Zone’: Researchers Decry Trump Administration Assault On Science

Interview

Featured Fellow:
  • Holly Fernandez Lynch, JD, MBE
March 27, 2025

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