New GHTF Expected in 2013, Industry Works to Be Heard
A new regulator-only Global Harmonization Task Force (GHTF) is expected in 2013, as the previous task force’s study groups will finish up their work through the end of next year.
The mechanics of how the new group will operate will also be worked out over that time.
During a three-day closed-door meeting earlier this month in Brisbane, Australia, regulators assured devicemakers that “industry engagement with the new group will be timely and substantive,” Janet Trunzo, vice president of technology and regulatory affairs at AdvaMed, told D&DL.
The FDA echoed those sentiments. “Industry is a significant stakeholder in the process and agrees that their input to the harmonization effort is vital for continued success,” Lillian Gill, senior associate director at CDRH, told D&DL.
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