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
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.
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].
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
FDA Insights podcasts
Insight into issues facing the agency – including the COVID-19 pandemic and other emerging topics.
COVID-19 Resources for Laboratories and Manufacturers
Emergency Use Authorizations for Medical Devices
EUA Authorized Serology Test Performance
Independent Evaluations of COVID-19 Serological Tests
Testing Supply Substitution Strategies: Download the slide show file (PPT – 1.5MB) and click Slide Show > From Beginning.
Image credit: FDA