> The FDA does not take information from other countries into account. The FDA d... | Hacker News

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slashdave on Sept 7, 2024 | parent | context | favorite | on: Four Thieves Vinegar Collective – Harm Reduction f...

> 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 on Sept 8, 2024 [–]

The 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.

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