Regulatory evaluation of antiviral drug resistance in the era of next-generation sequencing.
FDA/OMPT/CDER/OND/OAP/Division of Antiviral Products, Food & Drug Administration, Division of Antiviral Products, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Eric F
EF
Donaldson
FDA/OMPT/CDER/OND/OAP/Division of Antiviral Products, Food & Drug Administration, Division of Antiviral Products, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Damon J
DJ
Deming
FDA/OMPT/CDER/OND/OAP/Division of Antiviral Products, Food & Drug Administration, Division of Antiviral Products, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Julian J
JJ
O'Rear
FDA/OMPT/CDER/OND/OAP/Division of Antiviral Products, Food & Drug Administration, Division of Antiviral Products, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Lisa K
LK
Naeger
D016477:Artifacts; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D024882:Drug Resistance, Viral; D059014:High-Throughput Nucleotide Sequencing; D012926:Social Control, Formal; D014481:United States; D014486:United States Food and Drug Administration
antiviral drug resistance; next-generation sequencing; resistance-associated substitutions; treatment-emergent substitutions