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Lauded By Industry, Loathed By FDA? New HHS ‘Good Guidance’ Rule Likely Ruffling Feathers

 
• By Shawn M. Schmitt

A Good Guidance Practices regulation from the US HHS, pushed through the rulemaking process in the waning days of the Trump administration, will likely delight the medtech industry and be pushed back on by the FDA, experts tell Medtech Insight.

Man with birds and stars spinning around his head.
The new rule from the HHS will probably leave the FDA dizzy

A new final regulation on guidance documents pushed through the rulemaking process by the US Department of Health and Human Services (HHS) in the waning days of the Trump administration will likely be lauded by industry and loathed by the Food and Drug Administration.

The HHS – the overseer of the FDA, and 27 other agencies and offices – rolled out its Good Guidance Practices rule in the Federal Register on 7 December....

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