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Drug approval process speeds up


The fast-tracking of new drugs by the US Food and Drug Administration (FDA) has sped up clinical and approval times, according to a study by Tufts Center for the Study of Drug Development.

The study looked at 344 drugs that received at least one FDA fast-track designation since 1998. Total average clinical and approval time was 5% faster than for all drugs, 73.1 vs. 77.0 months.

The Tufts CSDD analysis, reported in the Tufts CSDD Impact Report, also found that fast-track designations have grown substantially, from an average of 22 per year during 1998–02 to 49 per year during 2003–07.

Anticancer candidates have received the largest share of fast-track designations since the programme began.

Indications are more likely to be terminated during development than nonfast-track indications, with efficacy being the primary reason for termination of fast-track-designated candidates.

Tufts CSDD provides strategic information to help drug developers, regulators and policymakers improve the quality and efficiency of pharmaceutical development, review and utilisation.

Based in Boston, it conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops and public forums.

Copyright PA Business 2008


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