Trial Design

FDA Finalizes Guidance on Vaginal Microbicides for HIV Prevention

Companies developing vaginal microbicide gels to prevent HIV infections should have a scoring system to measure the presence and severity of rash, swelling, immune response and damage to local tissue in human studies evaluating the safety and tolerability of the products, says a new final guidance. Read More

Biomarkers for Drug-Induced Kidney Injury Receive Boost From EMA, FDA

The European Medicines Agency has lent its support to an initiative to qualify biomarkers that can provide an early warning on an investigational compound’s risks of causing drug-induced kidney injuries, an endorsement that researchers say is necessary to move to the next phase of development. Read More