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Patient-Focused Drug Development: US FDA 'Needs To Be Brave,' Tell Sponsors What Works Best

 
• By Brenda Sandburg

At public workshop, FDA says it will be flexible on clinical outcome assessments but stakeholders want agency to specify no-no's; digital health technology is appropriate to get more accurate endpoints, agency says.

Doctor working in the office and listening to the patient, she is explaining her symptoms, healtcare and assistance concept

Sponsors want the US FDA to specify the best practices to pursue in patient-focused drug development and in what instances the agency will not be flexible. That was one of the messages that came out of a two-day public workshop intended to help the agency develop a series of guidances.

The Oct. 15-16 meeting was specifically focused on the methods used to identify what is important to patients, and the methods to select, develop or modify fit-for-purpose clinical outcome assessments...

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