Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency Guidance for Submitting HCV Resistance Data -Attachment to Guidance February 2013
Not for implementation. Contains non-binding recommendations.
- Docket Number:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
STANDARDIZATION OF COLUMN HEADINGS AND VARIABLES FOR HCV RESISTANCE DATASETS
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-0282.