- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
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:
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.