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GUIDANCE DOCUMENT

Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data: Attachment to the Guidance Draft Draft Guidance: This draft guidance updates the final guidance posted 6/2/06 February 2014

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2014-D-0180
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Sponsors are encouraged to use the following sample format for submitting HIV-1 resistance data.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-0180.

 
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