Article

Deficiency Patterns in FDA Complete Response Letters for New Drug and Biologics Applications: A Cross-Sectional Analysis

2026-06-16

Abstract excerpt

<title>Abstract</title> <p> This study provides one of the first systematic evaluations of publicly available FDA Complete Response Letters (CRLs) following transparency initiatives. This cross-sectional study analyzed 417 publicly available CRLs for NDAs and BLAs spanning more than two decades. A keyword-based codebook, developed through iterative review and manual validation, classified deficiencies into prede...

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Literature Corpus work: feabb0f3-8b52-57d5-876e-ad074953267a
DOI: 10.21203/rs.3.rs-9918124/v1

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