Zdrowie i gospodarka · 05/01/2021
FDA Publishes Draft Guidance for IND Submissions of Individualized Antisense Oligonucleotide Drug Products
The FDA is releasing a draft guidance to help sponsors of individualized antisense oligonucleotide drug products navigate FDA regulations and processes for developing treatments for severely debilitating genetic diseases.
Source: Federal Register — Food and Drug AdministrationOpen original release →