|Articles|May 20, 2014

FDA Beats PMDA and EMA on Oncology Approvals

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.


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The clinical research industry talks about patient-centeredness constantly but embeds it too late, too narrowly, and without clear ownership, and the cost shows up in enrollment failures, protocol deviations, and outcomes that don't reflect what patients actually care about.