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Category Archives: FDA

No CE mark? No problem.

Changes to legislation have increased flexibility for Sponsors looking to market medical devices in Australia. Historically the TGA has only recognised EC certificates from European notified bodies or a TGA conformity assessment to support the inclusion of a Medical Device … Continue reading

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FDA tick of approval: Commercial Eyes’ Drug Safety Group has been successfully audited by the FDA!

Commercial Eyes has been successfully audited by the US Food and Drug Administration (FDA) and found to have no written 483 observations. This is an excellent result that confirms Commercial Eyes’ reputation as the foremost pharmacovigilance and medical information provider … Continue reading

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