Known as Expanded Access Programs in the US, early access programs (EAP) allow access to medicines for certain patients before marketing authorization.   The French early access program, authorization for temporary usage or temporary authorization (“autorisation temporaire d’utilisation” - ATU),…

Late-stage American biopharmaceutical companies in late-stage development for their product are logically interested in the European market, and we clearly see a trend of companies looking to expand in Europe by themselves rather than partnering with an establishment based there.…