Expanded Access as a Key Component in the Development and Launch Process On February 20, 2020, Inceptua hosted a webinar on industry trends in pre-approval access to medicines. You…
Stuart BellMarch 3, 2020
Policies on pre-approval access (‘early access’, ‘expanded access’ etc.) have come into focus since the enactment of the US 21st Century Cures Act. Driven by the requirements of the Act,…
Stuart BellAugust 17, 2019
Underlining the tendency, a poll in one of the DIA sessions revealed that 30% of the industry delegates attending the meeting believe that RWD may actually be more relevant than…
Stuart BellJune 28, 2019
With the raised profile of pre-approval access (thanks in part to Right-to-Try and the 21st Century Cures Act) there has been a noticeable increase in the number of companies and…
Stuart BellSeptember 26, 2018
The US is the most straight forward of all countries for collecting data within an Early Access Program (EAP), due to clear guidelines, requirement for a protocol and site contracting.…
Stuart BellMay 1, 2018
Pre-approval access (early access, expanded access, named patient supply etc.) is a hot topic at present, especially with the high-profile discussions around Right-to-Try which are making the headlines around the…
Stuart BellFebruary 28, 2018