The need for a better defined and controlled approach to new therapies for possible neonatal application appears clear in light of present practice and recent history. At this conference several animal models were discussed that could be used for pharmacokinetic and pharmacodynamic studies and for evaluation of efficacy and safety prior to human newborn testing. This, coupled with a requirement for comprehensive human data collection following preliminary approval of new drugs, would, we believe, significantly improve present practice. It will, however, require pressure from the medical community and patient advocates to encourage change in current government regulations and industry policies.