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FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis
Session Chair(s)
Lina AlJuburi, PHARMD, MSC
Head, Regulatory Science and Policy, North America
Sanofi, United States
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 Objective : 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.
Speaker(s)
Panelist
Eva Temkin, JD
Arnold & Porter, United States
Partner
Panelist
Representative Invited
FDA, United States
Panelist
Amanda Conti
United States
Panelist
Eric Gascho
CRD Associates, United States
Vice President
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