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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To give stakeholders more time to respond, FDA has extended its comment period on a draft guidance that addresses next-generation sequencing tests that are used to detect microbes and antimicrobial resistance.

DNA

Stakeholders will have more time to mull FDA's May draft guidance on next-generation sequencing (NGS) tests to detect microbes, antimicrobial resistance and virulence markers. The agency originally set Aug. 11 as the end of the public comment period, but in response to requests for more time, formal feedback will now be accepted by FDA through Sept. 12.

The guidance attempts to explain how infectious-disease NGS test developers can meet analytical and performance thresholds to pass regulatory muster....

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