4 ms·
Why does it focus on US? I haven’t seen these in Europe either.
by jb1991 4y ago
Why does it focus on US? I haven’t seen these in Europe either.
- Rebelgecko 4y agoThe website is a branch of an American newspaper so not surprisingly has a US focus. I think some of the challenges to get the tests in the US are uniquely American. In some cases the FDA has a tendency to drag its feet (case in point, the gray market of imported sunscreens that are approved in Europe or Asia but not the US)
- vinay427 4y agoThere are likely more data points here than sunscreens. One study [1] seems to indicate that the EMA is typically slower to approve drugs that both the FDA and EMA end up approving. Another article [2] seems to reach a similar conclusion, where the FDA typically approves faster than the EMA, but when this is not the case there tends to be a larger gap between EMA and FDA approval. More to the point, perhaps, the at-home flu tests in question seem to have been approved in Europe, or at least received the CE mark which is some level of authorization. [3] [1] https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.1575 https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.15... [2] https://www.bioprocessonline.com/doc/first-in-line-fda-vs-ema-biopharma-approval-times-0001 https://www.bioprocessonline.com/doc/first-in-line-fda-vs-em... [3] https://www.lucirahealth.com/lucira-receives-ce-mark-for-both-covid-19-and-flu-and-covid-19-molecular-tests/ https://www.lucirahealth.com/lucira-receives-ce-mark-for-bot...