At its Feb. 23 review of Chelsea Therapeutics’ investigational orthostatic hypotension drug droxidopa, FDA’s Cardiovascular and Renal Drugs Advisory Committee will be asked to discuss sufficiency of the short-term efficacy data, clinical meaningfulness of the effect size and safety issues, including Japanese post-marketing reports of neuroleptic malignant syndrome.

AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.

Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.