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Former Official Petitions US FDA To Stop Reviewing Russian Firms' Applications Amid Ukraine Invasion

Executive Summary

Request from Tim Coté, former Office of Orphan Products Development director, could drag agency back into a political arena it's been trying to avoid. Coté, now consulting through Only Orphans Coté, filed a citizen petition asking agency to “completely freeze all administrative actions on any regulatory requests,” from drug and device companies headquartered in Russia or with majority Russian ownership.

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