Guidance for submitting influenza resistance data
by FDA Center for Drug Evaluation and Research
This white paper by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) offers guidance for submitting influenza resistance data. Sponsors are encouraged to use the presented sample format for submitting such data for microbiology review. One dataset combines patient, virologic, genotypic and phenotypic data. Selected clinical outcome data can also be included for exploratory analysis. This paper offers recommendations for constructing datasets and describes information that could be included with suggested column headings.
| Published: | 2006 |
| Format: | |
| Length: | 5 pages |
| Type: | White paper |
| Language: | English |
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