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.
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