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Kaiser Health News reports on work published in the Journal of the American Medical Association (DOI: 10.1001/jama.2017.5150). In the journal article, the researchers concluded that
Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postmarket safety event. Biologics, psychiatric therapeutics, and accelerated and near–regulatory deadline approval were statistically significantly associated with higher rates of events [...]
According to the Kaiser Health News article, the 21st Century Cures Act, enacted in December,
[...] offers ways to speed drug approval by pushing the FDA to consider different kinds of evidence beyond the three phases of traditional clinical trials. The new process has made some researchers worry that it will open the door for more unsafe approvals.
additional coverage:
(Score: 0) by Anonymous Coward on Sunday May 14 2017, @03:51PM
Safety predictions will always be limited by small sample sizes and trial duration.