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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.