FeaturedMedicines Access

Pre-approval Access

Regulatory Update 2020 Stuart Bell, Vice President, Consulting, Inceptua Medicines Access The regulations governing pre-approval access (early access, expanded access, compassionate use, named patient supply etc.) are constantly being updated…
Stuart Bell
November 6, 2020
Update

Pre-Approval Access Policy

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 Bell
August 17, 2019
Update

Small Data for a Big Benefit

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 Bell
June 28, 2019