Covid-19 diagnostics
Regulation of diagnostic testing (apart from CLIA lab-based tests) is the purvue of CDRH. In 2020 CDRH approved ~325 Covid diagnostic tests. I was recruited to the review of PCR-based tests and was pre-reviewer on 25 of them. This was a very difficult time during the pandemic, working at home and still doing genotoxicity safety reviews and trying to balance funded research projects as well. I did appreciate working with the diagnostics office teams, though. These were quite difficult reviews and the staff was very smart. All, from Office Director on down were impressive in their dedication, including in the transparency of weekly public phone conferences with the regulated industry creating the tests. I always tuned in to these to understand the technical nuances and to keep up with what was going on. Practically everyone suffered mentally from the work and the pressure. I only did this for 6 months. This was certainly one of the agency’s finest hours. I was proud to be part of it.
Covid era non-lab projects .
Many groups embarked on collaborative projects via Zoom, including HESI and several Leadscope sponsored projects related to carcinogenic risk (Tice et al. 2023, Bassan et al. 2024). Three non-lab proposals for research funding were approved in 2020 but were slow to develop due to other priorities. One utilized, once again, my experience in photobiology (Vig et al., 2023). Among the most interesting was the analysis of >10,000,000 adverse event reports and sex-based differences in the CDRH MAUDE database, funded by the FDA Office of Women’s Health. This was essentially a fishing expedition to find out what was being reported. We demonstrated the opportunities for novel analysis concerning sex-based effects in women, and other results benefitting the public health. An example ofnon-hypothesis driven research , I count it as one of my most important publications (Liao et al. 2024).