Drugs From Sponsors ‘Located in Russia,’ Would Be Barred From US FDA Review By House Funding Bill
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.
You may also be interested in...
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.
Five-year plan includes multi-phased approach to ALS at the same time that Amylyx’s AMX0035 is pending review with a late September decision deadline; action plan’s mid-term priorities for FY 2023-2024 include a cell and gene therapies safety project.