FDA Beats PMDA and EMA on Oncology Approvals

May 20, 2014

Applied Clinical Trials

FDA hands down beats other regulatory authorities in approving oncology drugs.

As first reported by Alec Gaffney

of the news arm of the Regulatory Affairs Professional Society, the FDA hands down beats other regulatory authorities in approving oncology drugs.

In his article, Gaffney reports on

FDA Commissioner’s Margaret Hamburg, MD, blog

on achievements at the FDA. The oncology approvals were only one highlight from a report issued by the Centre for Innovation in Regulatory Science. In that report, CIRS found that the median approval times for anti-cancer beats median approval times for anti-cancer drugs in days was 450 for the EMA, 365 for the PMDA and 240 for the FDA.