In a report about its 2004 accomplishments, the US Food and Drug Administration (Rockville, MD, www.fda.gov) cited a continuing drop in the median approval times for priority and standard new drug applications (NDAs) and biologic license applications (BLAs). Approval times for new molecular entities (NMEs) and new BLAs under priority review also dropped, although approval times for those under standard review increased slightly.
FDA’s Center for Drug Evaluation and Research (CDER) approved 29 drugs last year under its priority review program (available for drugs with the potential for significant advances over existing treatments), and approved 90 drugs after standard review. The median approval time for priority-review products was 6.0 months (down from 7.7). The standard approval time was 12.9 months (down from 15.4). Both figures include BLAs for biologic products transferred to CDER from the Center for Biologics Evaluation and Research (CBER) in the fall of 2003. CBER approved two BLAs in 2004, with an average approval time of 19.77 months.
Of the drugs approved by CDER, 36 had novel structures, classified as NMEs or new BLAs, up from 21 in 2003.
The total number of NDA submissions to CDER was 108, down slightly from 110 in 2003 (see chart). At the same time, the Office of Generic Drugs approved 474 applications in 2004, up from 364 in 2003, also with a faster median approval time (15.7 months compared with 17.0).
For the full report