FDA ..surrogate trial endpoints for approval ?!

 House stamps approval on fast-track approach to drug development    May 31, 2012 | By John Carroll    Members of the U.S. House of Representatives overwhelmingly backed new user-fee legislation that includes a section on accelerating the review of new drugs that offer treatment for a serious or life-threatening condition--a broad mandate likely to draw close scrutiny from everyone engaged in drug development.   The passage of the House and Senate bills--which will now be reconciled--marks the culmination of months of intense lobbying by the biopharma industry: voices which have been insisting that the FDA needs to be more responsive to drug developers and more open to a quick-step review process.    "A new generation of modern, targeted medicines is under development to treat serious and life-threatening diseases, some applying drug development strategies based on biomarkers or pharmacogenomics, predictive toxicology, clinical trial enrichment techniques, and novel clinical trial designs, such as adaptive clinical trials," notes the legislation, laying the stage for the FDA to designate drugs that can be fast-tracked using surrogate trial endpoints or other tools to accelerate a review.