The drug lag and associated factors for orphan anticancer drugs in Japan compared to the United States

In conclusion, we revealed that an approval lag for orphan anticancer drugs still existed in 2016–2017. A submission lag for orphan anticancer drugs was the main component affecting the approval lag, and was longer than that for non-orphan drugs. External collaboration in drug devel opment may be a potential factor in reducing the submission lag for orphan anticancer drugs.
Source: Investigational New Drugs - Category: Drugs & Pharmacology Source Type: research