Deep Dives

Understanding requirements for label inclusion of home administration in Europe and the US

Brief

To understand the requirements for label inclusion of home administration in Europe and the US.

Dive

Using literature, guidelines and selected case studies we identified the regulatory and clinical developments that enable US/EU drug label approval of home administration for oncology assets.

Discovery

Analogs highlighted different approaches to transitioning a clinic-delivered product into the home environment. Following deep-dives client commissioned 12 month monitoring project, include coverage of four conferences, to identify technological developments in this area.


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