SoylentNews

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 [...]

[...] 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.