FDA Reports Increase in Applications, Decrease in Approval Times for 2004

The FDA was able to shave a significant amount of time off the drug-approval process in 2004, despite approving 65 percent more new product applications than in 2003, according to new figures released by the agency.

The median approval time for new drug applications (NDAs) and biologic license applications (BLAs) granted priority review fell to six months in 2004, compared to 7.7 months in 2003, the agency said in its 2004 FDA Accomplishments report. New product applications undergoing standard review were approved in an average of 12.9 months, compared to 15.4 months in 2003.

The quicker review times came despite an increased number of product approvals. The agency approved 119 NDAs and BLAs in 2004, an increase of 65 percent over the 72 approvals granted in 2003. The 119 approvals in 2004 were the highest total since the FDA approved 121 NDAs and BLAs in 1997.

The one category where FDA approval times increased last year was in the review of new molecular entities (NMEs) and new BLAs undergoing standard review. The median approval time for those applications was 24.7 months, compared to 23.1 months in 2003. However, review times for NMEs and new BLAs granted priority-review status decreased slightly, falling to six months in 2004 from 6.7 months in 2003.

To view the FDA report, go to http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01346.html (http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01346.html).