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GUIDANCE DOCUMENT

Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HBV Resistance Data June 2006

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2005-D-0183
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Sponsors are encouraged to use the following sample format for submitting HBV resistance data. One dataset combines patient data, endpoint data, genotypic data, and phenotypic data. There are a number of ways datasets can be subdivided (i.e., by clinical study, baseline isolates, or virologic failure isolates) and this should be discussed with the division before submission.

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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-2005-D-0183.

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