FDA

Efforts to develop anti-terrorism treatments and to fully include women in studies will both affect clinical research.

While Health and Human Services builds a comprehensive program to ensure the safety of human subjects, Congress weighs proposals to stiffen the rules.

As the public clamors for early access to promising new drugs, sponsors worry about the consequences of experimental therapy conducted outside of controlled trials.

As the debate on clinical research policy continues, FDA is setting standards for pediatric studies and encouraging more sex-specific analysis of clinical data.