FDA Issues Final Guidance on Electronic Filings

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 05-05-2015 16:19


The US Food and Drug Administration (FDA) has issued final guidance, Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. The guidance implements the electronic submission requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the electronic format of the content submitted in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the FDA's Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). 

The guidance specifies the types of submissions that must adhere to the electronic submission requirement described in the guidance document, the timetable for implementation of electronic submission requirements, the types of submissions that are exempted from the electronic submission requirement described in the guidance document, and the eCTD specifications.The guidance requires that submissions filed electronically must follow the specifications set forth in the guidance document within 24 months after the publication of this final guidance for NDAs, ANDAs, BLAs, and master files.The requirement for INDs takes place 36 months after this guidance is published.

Source: FDA


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