CMC Regulatory Updates In Brief: CSL's Haegarda Specs; CMC Data Elements; ICH Q3C Maintenance

Redacted review documents posted July 12 show how the typical back-and-forth between applicants and reviewers on control strategy and specifications played out in the case of CSL Behring's Haegarda hereditary angioedema biologic treatment, which FDA's Center for Biologics Evaluation and Research had approved June 23, and which became available on the US market July 25.