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Deputy Commissioner Scott Gottlieb To Leave FDA In January

This article was originally published in The Gray Sheet

Executive Summary

FDA Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb plans to return to the American Enterprise Institute to work on health policy issues following his resignation from the agency effective Jan. 16

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GHTF selects new heads: FDA Office of Science & Engineering Laboratories Director Larry Kessler is appointed chair of the Global Harmonization Task Force, effective Jan. 1. For the next 18 months, Kessler will serve alongside AdvaMed's Executive VP-Technology & Regulatory Affairs Janet Trunzo in her recently announced position as GHTF vice chair to promote the convergence of global regulatory practices for the medical device industry. Since its founding in 1992, the voluntary group of medical device regulatory authorities and trade associations from the United States, Europe, Canada, Japan and Australia has issued a variety of harmonized guidances on the safety, effectiveness and quality of medical devices, promotion of technological innovation, and international trade. Kessler, who replaces outgoing GHTF Chair Georgette Lalis from the European Commission, previously headed a GHTF study group that set a standard for a unified, international system for reporting medical device adverse events and established the National Competent Authority Reporting program for regulators to share post-market information...

People In Brief

GHTF selects new heads: FDA Office of Science & Engineering Laboratories Director Larry Kessler is appointed chair of the Global Harmonization Task Force, effective Jan. 1. For the next 18 months, Kessler will serve alongside AdvaMed's Executive VP-Technology & Regulatory Affairs Janet Trunzo in her recently announced position as GHTF vice chair to promote the convergence of global regulatory practices for the medical device industry. Since its founding in 1992, the voluntary group of medical device regulatory authorities and trade associations from the United States, Europe, Canada, Japan and Australia has issued a variety of harmonized guidances on the safety, effectiveness and quality of medical devices, promotion of technological innovation, and international trade. Kessler, who replaces outgoing GHTF Chair Georgette Lalis from the European Commission, previously headed a GHTF study group that set a standard for a unified, international system for reporting medical device adverse events and established the National Competent Authority Reporting program for regulators to share post-market information...

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