Biotech CEOs Take Assertive Stance On Ukraine War, While PhRMA Remains More Neutral
PhRMA wants to ensure medicines remain available, as many smaller companies and other stakeholders call for ‘disengagement’ from Russia.
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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.
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.
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.