Pharma Companies Are Suspending Trials In Russia – But For Practical More Than Ethical Reasons
While pharma is keen to condemn Russia’s aggression, suspension of trials is driven by logistical considerations; US FDA said it stands ready to assist sponsors of disrupted trials in Russia and Ukraine to help ensure the safety of trial participants and integrity of the studies.
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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.
Amid the continuing conflict and the Russian shelling of hospitals in Ukraine, regulatory bodies, health authorities and clinical research organizations are issuing guidance on how to deal with the impact on clinical trials in both Ukraine and Russia.
PhRMA wants to ensure medicines remain available, as many smaller companies and other stakeholders call for ‘disengagement’ from Russia.