File:Fig4 Goldberg mBio2015 6-6.jpg

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Summary

Description

Figure 4. he FDA is considering the following information for the clearance/approval of an infectious disease NGS-based test/assay. The FDA presubmission process can be utilized for outstanding questions and to request additional information while policy is still being developed (26). IRB, institutional review board.

Source

Goldberg, Brittany; Sichtig, Heike; Geyer, Chelsie; Ledeboer, Nathan; Weinstock, George M. (2015). "Making the leap from research laboratory to clinic: Challenges and opportunities for next-generation sequencing in infectious disease diagnostics". mBio 6 (6): e01888-15. doi:10.1128/mBio.01888-15. PMC PMC4669390. PMID 26646014. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4669390. 

Date

2016

Author

Goldberg, Brittany; Sichtig, Heike; Geyer, Chelsie; Ledeboer, Nathan; Weinstock, George M.

Permission
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Creative Commons Attribution-Noncommercial-ShareAlike 3.0 Unported

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Date/TimeThumbnailDimensionsUserComment
current17:37, 20 September 2016Thumbnail for version as of 17:37, 20 September 2016750 × 610 (94 KB)Shawndouglas (talk | contribs)