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FDA’s First Notice of Noncompliance with requirements

On 28 April 2021, the FDA issued its first Notice of Noncompliance to a company failing to submit required summary results information to They determined that the responsible party failed to comply with its legal reporting obligations, even after receiving a Pre-Notice of Noncompliance. They will now have 30 days to submit the required summary results information or face civil monetary penalties for both the violation and the failure to submit the required information.

Read the FDA’s Full Press Announcement

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