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Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency Guidance for Submitting HCV Resistance Data -Attachment to Guidance February 2013

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2005-D-0282
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

STANDARDIZATION OF COLUMN HEADINGS AND VARIABLES FOR HCV RESISTANCE DATASETS


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