The purpose of this technical specifications document is to provide the current thinking of FDA’s Division of Antiviral Products (the Division) in regard to the submission of next generation nucleotide sequence analysis procedures and data in support of resistance assessments for the development of antiviral drug products.
The Division performs independent analyses of all resistance data associated with antiviral drug products being developed to ensure that the emergence of resistance is carefully characterized and explained in the label of newly approved antiviral drug products. Providing accurate resistance information is imperative for protecting public health to prevent the emergence of novel resistant and cross-resistant viral variants that have the potential to infect others and cause major outbreaks of disease that cannot be controlled by approved drug products. In addition, the resistance information provides important guidance for health care professionals who oversee the use of antiviral drug products and is included in the drug product information approved by the Division. Moreover, the Division can request data for nucleotide sequence analysis of host-targeted genes for polymorphism analysis to determine if different population-based alleles have an effect on efficacy.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.