3 ms·
There 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
by vinay427 4y ago
There 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...