Product Uptake By Country PA-NPPs adhere to strict legislation regarding the supply of unlicensed medicines on an unsolicited request basis. As such, there are many factors that determine the level of uptake in a PA-NPP, [...]
EAP VERSUS OLE Both an Open Label Extension (OLE) and an Expanded Access Program (EAP) can be used to provide continued treatment access after phase 3 clinical trials have ended.To help companies understand both programs [...]
SPONSOR CONSIDERATIONS FOR EAPs If your company is developing a drug that fulfils an unmet clinical need, you may have already started receiving patient enquiries about expanded access.We have put together this downloadable resource that [...]
EXPANDED ACCESS POLICY TEMPLATES If your company is developing a drug that fulfils an unmet clinical need, you may need an Expanded Access Policy on your website.We have provided three templates, one for each of [...]