EMA Seeks Comments on Revised Guidelines for Antibiotic Trials
The European Medicines Agency released revised guidelines for stakeholder comment on evaluating drugs for treating bacterial infections.
The revised draft reflects discussions between EU, U.S. and Japanese regulators on aligning data requirements so drug developers can design clinical trials that meet the needs of multiple regulatory agencies.
The revised document includes new information on developing antibacterial agents to address unmet medical needs. It also includes specific advice on EU regulatory requirements for developing medicines for the treatment of uncomplicated urinary tract infections and gonorrhea.