Zdrowie i gospodarka · 27/04/2021
FDA Publishes Draft Guidance for Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products
The FDA has released a draft guidance to assist sponsors in developing nonclinical data to support IND applications for individualized antisense oligonucleotide (ASO) treatments targeting rapidly progressing, severely debilitating or life-threatening diseases caused by unique genetic variants.