US FDA Gives More Time For Public Response To NGS Microbial Identification Guidance
To give stakeholders more time to respond, FDA has extended its comment period on a draft guidance that addresses next-generation sequencing tests that are used to detect microbes and antimicrobial resistance.
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US FDA is holding a workshop at NIH headquarters on Sept. 23 to get public feedback on two important draft guidances that provide sponsors with more clarity on the agency's thinking on next-generation sequencing tests.
Two recent next-generation sequencing draft guidances have been positively received so far by industry and clinical research groups. But for FDA's ideas to play out, more databases will need to be populated and more standards developed, agency officials say. There are also more guidances to come on different types of NGS tests. Read our coverage below, and also listen to our podcast interview with FDA's Elizabeth Mansfield.
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