7 December 2021 - Today, the FDA is issuing a draft guidance to provide recommendations for managing the administration of individualised investigational antisense oligonucleotide drugs in a clinical trial and conducting clinical assessments of the safety and response during administration of the investigational antisense oligonucleotide drug.
The draft guidance describes important clinical considerations for investigational new drug application submissions to support initial and continued administration, dosing and clinical monitoring of an individual who is eligible to receive an individualised investigational antisense oligonucleotide drug.