RE:RE:RE:RE:RE:Q: what's with the "ethics review board"?I don't think the NR was well written... too many run on sentences, and it was confusing.. It comes down to changes were made to Guidelines to ensure the test is easy to use. and key words "non-lab Covid 19 tests. This will all be complete within 2 weeks.
Findingmoney wrote: And here I thought it was due to:
The evaluation protocol for these studies incorporates aspects of the revised guidance released by the FDA on July 29, 2020. The FDA's new template for commercial developers of non-lab COVID-19 tests included updated guidance on performance evaluation studies, comparator methodology, flex studies, human usability studies, and clinical evaluation, amongst other study components.