Analyses have shown 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?
Some companies took years to submit their applications. Ivabradine took 51 months but in contrast Rivaroxiban took only 4 months. Although analysing data and writing a trial report may be time consuming, reducing the time that companies take to submit their applications seems like an appropriate and worthwhile achievement.
Submitting applications by drug companies showed the most delay and therefore may provide the best opportunity to speed up approval. 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 speed may arise. However, to accelerate FDA drug approvals by lowering standards may prove costly for patients and healthcare budgets.