CDER Issues Guidance on Next Generation Sequencing Data for Antiviral Products

CDER released final guidance on Thursday on submitting next generation nucleotide sequence (NGS) data to support resistance assessments for antiviral drugs.

NGS raises some new technical issues because it provides sequence information for individual viruses, with millions or even billions of sequences per sample. This makes it harder for the agency’s reviewers to validate the data.

The FDA’s Division of Antiviral Products conducts independent analyses of resistance data for antivirals to ensure that resistance is addressed in the labeling of new antivirals. The division will accept data from most NGS platforms, but the sponsor “should submit a detailed protocol that describes sample processing and NGS analysis procedures,” the guidance says.