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

US FDA explains why it requested CSL Behring to reinstate non-critical manufacturing process controls and tighten container specs in line with process capability. FDA also proposes CMC data elements and posts ICH Q3C updates.

Marburg Germany Plasma Pooling
Plasma pooling at Marburg, Germany, plant where CSL Behring makes Haegarda • Source: CSL Behring

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.

There is an oft-discussed tendency for applicants to seek greater latitude in manufacturing process controls and specifications, and for FDA...

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