The FDA resumed issuing complete response letters (CRLs), posting 14 new rejection letters after a pause linked to calls for greater transparency. The move comes after HHS confirmed to Endpoints News that the agency had paused new CRL releases. For biopharma developers, the resumption is a practical signal for timelines: CRLs can reset regulatory expectations and force additional work on manufacturing, labeling, or clinical data packages. The new batch includes camrelizumab plus rivoceranib from Hengrui and Elevar, highlighting continued scrutiny on complex oncology regimens. While the content of each CRL batch varies, the agency’s stated rationale centers on process—an attempt to normalize throughput while maintaining a clearer public record of decisions.