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#412: FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis
Monday June 15, 2026 11:00am - 12:15pm EDT
201AB
Component Type: Forum
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-26-523-L04-P; CME 1.25; RN 1.25

This session aims to provide a comprehensive analysis of the FDA's practice of publicly posting CRLs. We will examine the past year's data, identify emerging trends, and assess the implications of this transparency initiative.

Learning Objectives

Discuss FDA's process for issuing and publicly posting Complete Response Letters (CRLs); Analyze trends in CRLs over the past year, including common reasons for issuance; Evaluate the benefits and potential drawbacks of public CRL disclosure.

Chair

Lina AlJuburi, PHARMD, MSC

Speaker

Panelist
Eva Temkin, LLM

Panelist
Amanda Conti

Panelist
Eric Gascho


Speakers
avatar for Lina AlJuburi

Lina AlJuburi

Head, Regulatory Science and Policy, North America, Sanofi, United States
A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... Read More →
avatar for Amanda Conti

Amanda Conti

Senior Research Analyst, Agencyiq By Politico, United States
EG

Eric Gascho

Vice President, CRD Associates, United States
Eric is a Vice President at CRD Associates and the Executive Director of the Coalition for Health Funding, positions he has held since 2024. He has extensive experience in a variety of legislative and regulatory policy issue areas, including federal budget and appropriations, public... Read More →
avatar for Eva Temkin

Eva Temkin

Partner, Arnold & Porter, United States
A partner in Arnold & Porter's Life Sciences and Healthcare practice, Eva provides strategic counsel to clients regarding significant and complex issues associated with FDA-regulated pharma and biotech. Formerly the acting Director for Policy in FDA's Office of Therapeutic Biologics... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   10: Stats-EvidenceGeneration-RWE, Forum
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Biostatistics
  • Tags Forum

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