Senator Kay Hagan, a North Carolina Democrat, and the Biotechnology Industry Organization are working to get approval for a plan that would fast track approval for drugs that treat conditions with no approved cures, according to a Bloomberg report.
The proposal is part of ongoing talks about reauthorization of the fee system pharmaceutical companies use to fund FDA reviews. The plan proposes to allows drug companies to conduct shorter trials that are based on a measured effect of a drug — such as tumor shrinkage — instead of a clinical outcome.
Agency officials told Bloomberg that the agency already has several fast-track options in place, and 75 percent of rare-disease treatments since 2006 have been approved based on limited trials.
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The proposal is part of ongoing talks about reauthorization of the fee system pharmaceutical companies use to fund FDA reviews. The plan proposes to allows drug companies to conduct shorter trials that are based on a measured effect of a drug — such as tumor shrinkage — instead of a clinical outcome.
Agency officials told Bloomberg that the agency already has several fast-track options in place, and 75 percent of rare-disease treatments since 2006 have been approved based on limited trials.
Related Articles on the FDA:
FDA's Dr. Jeffrey Shuren Speaks to Congress About Medical Device Approval
FDA Opens Comment Period on Device Reclassification Process
10 Recent FDA Drug and Medical Device Decisions