July 19, 2020 Drug & Device Advisory Group FDA Briefs

COVID-19 updates: Test for pooled samples, CTAP, Domestic inspections, FDA Insights podcasts, Laboratory and Manufacturer resources

Quest SARS-CoV-2 rRT-PCR test for pooled samples

Quest Diagnostics

Emergency Use Authorization for first diagnostic test use with pooled samples containing up to four individual swab specimens

Sample pooling allows for more people to be tested quickly using fewer testing resources
Samples collected from four individuals tested in pool or “batch” using one test, rather 4 tests
If pool is positive, each of the samples in that pool are tested again individually
Fewer tests are run overall, meaning fewer testing supplies and quicker test particulalry in areas with low prevalence, meaning most results are expected to be negative.

Package insert

Coronavirus Treatment Acceleration Program

The Coronavirus Treatment Acceleration Program (CTAP) to enable FDA to leverage cross-agency scientific resources and expertise to bear on COVID-19 drugs and biologics development and review

>510 drug development programs
>230 trials for otential therapies
email inbox for COVID-19 therapeutic development inquiries, [email protected].

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Resumption of domestic inspections with new risk assessment system

COVID-19 Advisory Rating system (COVID-19 Advisory Level) to assist in determining when and where it is safest to conduct prioritized domestic inspections

Uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data
Phase of the State, statistics measured at the county level to gauge the current trend and intensity of infection
Goal of restarting on-site inspections during the week of July 20

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