Zdrowie i gospodarka · 08/12/2021

FDA Publishes Draft Guidance for Sponsor-Investigators on IND Submissions for Individualized Antisense Oligonucleotide Drug Products

The FDA is releasing a draft guidance to help sponsors develop individualized antisense oligonucleotide drug products for rare, severely debilitating, or life-threatening diseases, providing clinical recommendations for submitting Investigational New Drug Applications (INDs).