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Accelerated approval not working

The US FDA's accelerated approval programme for NMEs is not achieving its aim, according to a multi-centre study

The US Food and Drug Administration's (FDA's) accelerated approval programme for new molecular entities (NMEs) is not achieving its aim, according to a multi-centre study published in the Journal of Clinical Oncology.

The initiative was set up in 1992 to try to speed up access to therapies for life-threatening conditions, including cancer. Researchers looked at data for accelerated and regular FDA approvals in oncology since 1995. The study shows that oncology NMEs in the accelerated programme reached market in a median time of 7.3 years and new drugs going through regular approval took a median of 7.2 years.

One of the problems, particularly for small biotech companies, is the cost of the large-scale studies now required by the regulators. The authors call for the FDA to return to basing approval for potentially life-saving drugs on smaller studies, in order to expedite access to new treatments for patients with terminal conditions.

28th July 2009

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