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International Harmonization: Industry Needs To Take The Lead, MEDIcept’s Trautman Says

 
• By Nielsen Hobbs

Discussing combination products, the CDRH alum bemoans the ‘handcuffs’ that prevent health authorities from making progress. ‘Industry needs to take this bull by the horns and … we have to look beyond just the mature regulators.’

International Flags Blowing In Wind_1200x675
• Source: Shutterstock

BOSTON—If industry wants to accelerate harmonization of combination product regulations, sponsors need to “lead that charge,” MEDIcept Inc. Managing Director Kimberly Trautman said.

“The office of international policy at FDA ..

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