1. Pink Sheet

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

Efforts to streamline the US Food and Drug Administration's expanded access program may be hindered by legal protections that the drugs' sponsors require of prospective patients' providers.

Agency officials have been trying to reduce the time and burden necessary for patients and physicians to gain access to unapproved therapies, usually through a single-patient investigational new drug application....

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