The US Food and Drug Administration will not contest a recent court decision that concluded radiology contrast agents should be treated as devices and not drugs. The agency says it plans to begin treating a slew of such products as devices, but advises companies to pay their drug and generic user fees now and ask for reimbursement later.
Imaging Drugs Make Jump To Devices In New Decision By FDA
After losing the recent Genus Medical Technologies court case, the US FDA will begin transitioning certain imaging agent drugs to devices.
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Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.
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The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.
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Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
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A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.