Effectiveness Based News Today

The U.S. Food and Drug Administration (FDA) is making efforts to modernize both the 510(k) approval process for medical devices and study designs for drugs and biologics.

The FDA is announcing the opportunity for a limited number of sponsors to participate in a pilot program allowing for more frequent communication with FDA staff to provide a mechanism for addressing late-phase product development issues.

Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence

Now that the budget debate has shifted to the appropriatingcommittees of Congress, the President must hold the line on hisgoal of retargeting the funds of programs such as COPS whoseeffectiveness has not been proven or that have been demonstrablyineffective.