The US Food and Drug Administration gets drugs to the market faster than other major regulators but it is still too slow. Can approvals be achieved quicker without affecting patient safety?
Companies can take years to submit their applications. Ivabradine took 51 months but in contrast Rivaroxiban took only 4 months. Analysing data and writing trial reports are time consuming, reducing the time that companies take to submit their applications is a worthwhile achievement.
It may be possible to accelerate drug approvals in other ways, for instance by changing processes earlier in the development programme, before the end of the pivotal trials.
To accelerate FDA drug approvals may be a challenging task but there are areas where the delay can be improved however, to accelerate FDA drug approvals by lowering standards may prove costly for patients and healthcare budgets.