2 ms·
> The FDA does not take information from other countries into account. The FDA doesn't care where data comes from. Much of drug testing in the US is done overs
by slashdave 2y ago
> The FDA does not take information from other countries into account.
The FDA doesn't care where data comes from. Much of drug testing in the US is done overseas in CROs.
> but its not approved in the U.S. as a sleep aid.
Approval is not automatic just because another country did so. Someone needs to take responsibility and formally apply.
- QuantumGood 2y agoThe issue is that foreign approval and use history are not allowed to be determinative factors for U.S. approval in an FDA review process, but rather as supportive information only.