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GUIDANCE DOCUMENT

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

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

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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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-0282.