US FDA Denies Petition Seeking Freeze On Russian Companies’ Regulatory Activities
The agency tells former OOPD Director Tim Coté that it does not have the authority to consider the sponsor’s country of origin when determining whether to act on an application.
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Language of the amendment cleared by appropriators in response to the Russian war against Ukraine in FDA’s fiscal year funding bill is vague, making impact of the funding ban on industry unclear. Democrats supported the amendment but said they wanted to continue to work on language to avoid “unintended consequences.” FDA would get a 10% bump in non-user fee funds under the bill.
PhRMA wants to ensure medicines remain available, as many smaller companies and other stakeholders call for ‘disengagement’ from Russia.
As Russia intensifies its invasion of Ukraine with missile attacks and a convoy of armored vehicles, the funder and promoter of the country’s COVID-19 vaccine, Sputnik V, has found itself the subject of punitive international sanctions alongside Russia’s Central Bank.