FDA Commissioner vows faster approvals

FDA will soon commit itself to reduce the median approval time for most drugs and biologics by 10%, FDA Commissioner Mark McClellan said Monday. The commitments will go beyond those mandated by the Prescription Drug User Fee Act by addressing for the first time the elapsed time from the submission of an NDA or BLA to an approval decision. The agency will "shift downward the time it generally takes to get a safe and effective new drug approved by FDA," he said in remarks at the Biotechnology Industry Organization's annual meeting in Washington, D.C.

The commitment involves a reduction in the median approval time for standard and priority drugs and biologics by about 10%. The benchmark, which will be phased in over a period of three years, will not apply to individual applications, but instead is intended as an average for all submissions during a given fiscal year. ...