FDA plans its version of reform

WASHINGTON - Under increasingly persistent demands from industry and Congress to reduce the regulatory burdens to the commercialization of new therapeutics, the FDA is organizing home-grown changes in the drug development and approval process, including focusing more of its attention and resources on Phase I and II trials.

In addition, the Center for Biologics Evaluation and Research (CBER) is working with the Center for Drug Evaluation and Research (CDER) on a joint document outlining their philosophical basis for approval decisions for proposed therapies that address serious conditions for which no effective treatment exists. ...