FDA Cites ZLB's Rhophylac Promotions For Risk Info Omissions
This article was originally published in The Pink Sheet Daily
Executive Summary
ZLB is revising a Rhophylac website and has discontinued a sales brochure and patient Q&A cited in the warning letter issued by the Center for Biologics Evaluation & Research. The "main parts" of the promotions did not include sufficient risk information, FDA says.