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US FDA Plans New Office Of Patient Affairs

 
• By Sue Darcey

A envisioned Office of Patient Affairs being would help the agency gain insight into patient understanding, and tolerance of risks and benefits of regulated products, the agency says.

US FDA is considering opening an Office of Patient Affairs to improve coordination between its various medical product review centers in gathering patient input on their acceptance of risks and benefits, it said in a March 13 notice.

Creating such an office would help fulfill one of the goals of the FDA Safety and Innovation Act (FDASIA) signed in July 2012, and was supported by the agency during...

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Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

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