A new study about the influence of data disclosures on physician decisions about off-label uses suggests that there is limited awareness of, and expos...
A new Government Accountability Office report recommends that FDA and other HHS agencies develop procedures for reporting and addressing allegations o...
FDA issues Teva Pharmaceuticals and MedinCell a complete response letter on their NDA for TV-46000/mdc-IRM (risperidone extended-release injectable su...
Federal Register notice: FDA announces a 5/18-19 meeting of the Science Advisory Board to the National Center for Toxicological Research (NCTR) Adviso...
Based on adverse events received, FDA sends Warning Letters to 12 companies for selling unapproved over-the-counter products intended to bleach or lig...
Two Arnall Golden Gregory attorneys recommend that drug companies keep all FDA promotion regulations in mind when they craft consumer and professional...
FDA says the Elgin-IL-based Regenerative Stem Cell Institute is marketing cellular products without an approved BLA or IND.
Three Morrison Foerster attorneys say a recent Connecticut federal court decision in a case involving Mercks Gardasil demonstrates there is a high bar...