FDA guidance says sponsors should provide 'convincing' proof of concept data to support INDs for individualised medicine


26 April 2021 - Recent draft guidance from the US FDA addresses the non-clinical safety data to support investigational new drug applications for individualised antisense oligonucleotide products, a type of personalised medicine.

The guidance, issued on 26 April, addresses investigational new drug applications for antisense oligonucleotides that treat a severely debilitating or life-threatening disease caused by a unique genetic variant. 

Such diseases may be amenable to RNA directed treatment.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation , Development