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).