3 ms·
The FDA does not accept any studies conducted overseas as clinical evidence. They request studies to contain at least 50% US citizens and be analyzed by US cert
by Aeolos 4y ago
The FDA does not accept any studies conducted overseas as clinical evidence. They request studies to contain at least 50% US citizens and be analyzed by US certified physicians.
Now whether that leads to better outcomes or is just a protectionist measure for the local industry is anyone’s guess. A bit of both, I would imagine.
- quickthrower2 4y agoWhy not? They could, and at least have strict criteria for how good the studies must be.
- junofan 4y agoThis is completely untrue. Foreign data may be used as the sole basis for marketing approval [1]. [1]: https://www.govinfo.gov/content/pkg/CFR-2006-title21-vol5/pdf/CFR-2006-title21-vol5-sec314-106.pdf https://www.govinfo.gov/content/pkg/CFR-2006-title21-vol5/pd...