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An Update on Regulatory Electronic Submission

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Adi Intellect
An Update on Regulatory Electronic Submission

The Federal Food, Drug, and Cosmetic Act (FD) has enacted a law under Section 745A(a) that the regulatory submissions including investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs) should be submitted in electronic format to Food and Drug Administration (FDA).

The ESG does not have access to open the documents, and it only receives, acknowledges receipt and directs the submission to the appropriate FDA center providing notification of delivery to the center.

At the first time, a draft protocol is presented to FDA for review, and it is called an original document.

All the amended submissions are based on the previous submissions except the original one.

FDA provides two options for review, i.e, Current View and Cumulative View: Current View shows only the current version of the document and does not show documents that have been deleted or replaced, and the Cumulative View shows the full lifecycle including all the versions that existed before the current version.

The validation and review of the study data are done at regular intervals throughout the submission process.

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