P76 The effect of the pregnancy and lactation labeling rule on prescribing information of FDA-approved drugs

Background The U.S. Food and Drug Administration implemented the new Pregnancy and Lactation Labeling Rule (PLLR) in June 2015. Under PLLR, all new drug applications were to present a narrative risk assessment (as opposed to letter category), while drug approvals after June 2001, were required to phase in by June 2020. The purpose of this study was to assess the quality of presented pregnancy and lactation data in the drug …