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FDA drug approvals on the rise despite slow development time

Wednesday, May 11, 2011 01:02 PM

The FDA has passed nearly twice as many biopharmaceutical drug approvals in the last 10 years than it did in the 1990s, a news release from the Tufts Center for the Study of Drug Development (CSDD) has indicated, according to Mass High Tech.

From 2000 to 2009, 65 biopharmaceutical drugs were FDA approved. In comparison, the 1990s saw 39 approvals, while the 1980s had 13 approvals, reports the CSDD study.

The numbers offer a counterpoint to the increasing average timeframe between the first clinical study to regulatory approval, which has bumped from 77 months for biopharmaceutical firms in the 1990s to an average of 95 months in the last decade. The average development period from 2000 to 2009 was not affected by orphan status nor fast track designation for biopharmaceutical drugs, says Mass High Tech.

Tufts CSDD recently published its Impact Report, which showed that more drugmakers are getting their already approved drugs passed by FDA for other indications.

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