RE: just a couple of thoughts.....11 Aug 2020 07:52
Ophidian with the new FDA Template (for PoC pregnancy style tests) has the EUA mechanism for FDA approval been stopped?
In March 20, the Roche PCR test EUA FDA process took 8 hours! For the UK PrimerDesign PCR test (submitted before the commencement of the EUA process) FDA approval took 6 weeks! Perhaps this was America first.
The importance in the Rockefeller Report of the joint Avacta/Cytiva PoC test will now be paramount. Hopefully, the US connection will speed up the FDA approval process.
Test, test, test