Description
The purpose of this guidance is to assist sponsors in the development of antiviral drugs and biological products (i.e., therapeutic proteins and monoclonal antibodies) from the initial preIND through the new drug application (NDA) and postmarketing stages. This guidance should serve as a starting point for understanding what nonclinical and clinical virology data are important to support the submission of an investigational new drug application (IND), NDA, or biologics license application (BLA) for approval of an antiviral product. This guidance focuses on nonclinical and clinical virology study reports and makes recommendations for collecting and submitting resistance data to the Food and Drug Administration (FDA). Nonclinical and clinical virology study reports, based on collected data, are essential for the FDA’s review of antiviral drug investigational and marketing applications.
Scope & Applicability
Product Classes
5Guidance on Antiviral Product Development
development and application review of antiviral products
development program for drug and biological products
Drug class (NRTIs) targeting HIV-encoded reverse transcriptase.
Drug class (NNRTIs) targeting HIV-encoded reverse transcriptase.
Stakeholders
2Target audience for recommendations on assessment of overall survival
responsible for justifying omission of studies
Regulatory Context
Attributes
4Determines if a product selects for resistance with few or multiple mutations.
acquisition of a single mutation results in a high degree of phenotypic resistance
Parameter discussed in antiviral activity analysis; An IQ is the Cmin/serum-adjusted EC50 value.
Narrow margins may necessitate dose adjustments
Identified Hazards
Hazards
1Linked to inhibition of human pol γ, leading to adverse events in humans.
See Also (8)
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- Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices (Status: Final)
- Non-Invasive Blood Pressure (NIBP) Monitor Guidance (Status: Final)
- Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions (Status: Final)
- Small Entity Compliance Guide: Declaration by Name on the Label of All Foods and Cosmetic Products that Contain Cochineal Extract and Carmine (Status: Final)
- Guidance for Industry: Questions and Answers About the Food Additive or Color Additive Petition Process (Status: Final)
- Color Additive Petitions - Medical Devices (Status: Final)
- Draft Guidance for Industry: Cosmetic Good Manufacturing Practices (Status: Draft)