The recent approval of new pregnancy and lactation labeling for UCB Group's Cimzia (certolizumab pegol) marks an advance for the US FDA's efforts to improve advice for prescribers debating whether expectant and breastfeeding mothers can continue medication, but the amount of work entailed illustrates some of the hurdles to providing clinical data in labeling for special populations.
The new Cimzia labeling, approved March 20, 2018, adds data from the "first-of-their-kind" post-marketing clinical pharmacokinetic CRIB and CRADLE...