Genentech is reviewing language with FDA to advise of cardiotoxicity risk as it prepares to submit trastuzumab for treatment of adjuvant breast cancer. The firm reports that there have been multiple inquiries to the medical communication group for information on the cardiac monitoring protocol used in the adjuvant trials.

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.