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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FDA Publishes Draft Guidance for Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products

The FDA has released a draft guidance to assist sponsors in developing nonclinical data to support IND applications for individualized antisense oligonucleotide (ASO) treatments targeting rapidly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.

Source: Federal Register — Food and Drug AdministrationOpen original release →