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Zdrowie i gospodarka · 08/12/2021

FDA Releases Draft Guidance for IND Submissions of Individualized Antisense Oligonucleotide Drug Products

The FDA is releasing a draft guidance outlining its recommendations for chemistry, manufacturing, and controls information needed to support IND submissions for individualized antisense oligonucleotide drug products for severely debilitating or life-threatening diseases caused by unique genetic variants.

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