Warning over data compliance in FDA submissions from September

20 August 2021

Drugmakers have been warned by PharmaLex over a change that they will face in the electronic product information that they have to provide to the US Food and Drug Administration (FDA) from mid-September.

Until recently, sponsors have been able to submit non-clinical and clinical reports without datasets and without fear of rejection.

However, this will change when the FDA implements eCTD validation checks when submissions contain content under modules four and five, beginning September 15, 2021.

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