This site is intended for health professionals only!

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


Most read

Latest Issue

Be in the know
Subscribe to Hospital Pharmacy Europe newsletter and magazine
Share this story: