EAP Versus OLE Study
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
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
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 [...]