FDA on Wednesday finalized guidance addressing frequently asked questions related to the development of cellular and gene therapy products.
The guidance is little changed from the draft version issued on 19 November 2024.
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- Using FDA's plausible mechanism framework to allow for greater use of causal inference may help with evidence generation for rare diseases, according to a recent paper published in The Journal of Clinical Investigation.
- FDA has updated its seven-year-old guidance to clarify the differences among abbreviated approval pathways and the data it will accept for these applications.
- President Donald Trump has named White House aide Heidi Overton to lead the FDA, he announced on Wednesday. hubs.la/Q04tC8p10
- While there have been growing concerns in recent years about whether FDA decision-making might be influenced by external factors, a recent scoping paper suggests that measuring such influence is a complex task.
