FDA 2014 Approvals Outpace Those of 2013

The FDA offered up an early retrospective of the 2014 year of approvals Friday with a rundown the regulator feels pretty good about.

The FDA offered up an early retrospective of the 2014 year of approvals Friday with a rundown the regulator feels pretty good about.

“Our Center for Drug Evaluation and Research (CDER) has so far approved 35 novel drugs in 2014 compared to 27 in 2013,” FDA commissioner Margaret Hamburg wrote on the agency's FDA Voice blog.

The approval pattern for the year—with a few weeks to go—shakes out as follows:

  • 15 of this year's approved new molecular entities were for orphan drugs, the highest number since the Orphan Drug Act passed in 1983.
  • The FDA approved almost 75% of novel drugs after one review cycle
  • 57% of the approved drugs had Priority Review tags, speeding up the approval process
  • 37% of novel drugs were on the Fast Track review route

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