US FDA Denies Petition Seeking Freeze On Russian Companies’ Regulatory Activities

Agency tells former OOPD director Tim Coté it doesn't have the authority to consider sponsor’s country of origin when determining whether to act on applications. Despite the denial of petition, FDA continues to support Ukraine.

Russia-Ukraine war
Multiple trade groups requested that pharmaceuticals be exempt from sanctions after Russian invaded Ukraine. • Source: Shutterstock

The US Food and Drug Administration concluded it does not have the authority to stop Russian companies’ application approvals for Rx and OTC drugs and medical devices and other actions because of the country’s invasion of Ukraine.

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