The US Department of Health and Human Services announced on Wednesday that it has authorized the Food and Drug Administration to issue emergency use authorizations for monkeypox tests.
The US Food and Drug Administration on Monday released revised guidance on its regulatory priorities and policies for COVID-19 tests.
The funding will be used to provide purchase commitments to manufacturers so they can scale up test production.
FDA will not require developers to submit a premarket approval application, premarket notification or emergency use authorization for laboratory developed tests, the Department of Health and Human Services announced on August 19th.
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