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FDA fails to monitor fast tracked drugs after approval, says US watchdog

BMJ 2016; 352 doi: http://dx.doi.org/10.1136/bmj.i371 (Published 20 January 2016) Cite this as: BMJ 2016;352:i371
  1. Owen Dyer
  1. 1Montreal

The US Food and Drug Administration is not properly keeping track of medicines that have reached the market after going through one of the agency’s rapid approval programs, says a report by the Government Accountability Office (GAO), the auditing service of the US Congress.1

“FDA’s data on post-market safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult,” the report concluded.

It said that fewer than half of the potential safety issues that had been identified during accelerated reviews, with the intention of monitoring them in the general …

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