US FDA Plans New Office Of Patient Affairs

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.

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Former FDA Head Tells Heart Society To ‘Get Involved’ To Protect Health Innovation

 
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‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.