2023-07185: Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Draft Guidance for Industry; Availability; Extension of Comment Period
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The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice announcing the availability of a draft guidance for industry that appeared in the Federal Register of February 13, 2023. In that notice, FDA requested comments on the draft guidance for industry entitled "Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development." The Agency is taking this action to allow interested persons additional time to submit comments.
The agency’s own summary, as published.
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