Expanded Access: Reducing The Contract Delay

 
• By Derrick Gingery

While the US FDA works to cut time necessary to approve expanded access applications, sponsors are creating delays by mandating patients and institutions sign contracts to gain access.

Timetable at the Central Station
Contract negotiations between the patient, provider and sponsor are among the most time-consuming portions of expanded access process, one company representative said. • Source: Shutterstock

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