Complete Response Letters (CRLs)
Comprehensive Analysis of FDA CRLs in 2025: Patterns, Sponsor Responses, and Outcomes
The FDA’s 2025 rejection of 20 drugs via Complete Response Letters (CRLs) highlighted challenges in efficacy and manufacturing. This review covers each case, post-CRL strategies, and the success of Elamipretide’s approval, offering insights into biopharma resilience and supply chain risks.