Issue Date: June 2, 2006
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final
Antiviral Product Development–Conducting and Submitting Virology Studies to the Agency : Guidance for Submitting Influenza Resistance Data
Sponsors are encouraged to use the following sample format for submitting influenza resistance data for microbiology review. Sponsors should begin these analyses in the earliest clinical stages of product development so that sample collection, storage, and analyses are well established at the time of the initiation of pivotal studies. If sponsors wish to submit additional information, they are encouraged to discuss these suggestions with the division in advance.
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