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FDA Sets Deadline for Requiring Electronic Submissions of Certain Drug Filings, Including DMFs

The U.S. Food and Drug Administration (FDA) has established a deadline after which all new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) will need to be submitted electronically. Section 745A(a) of the Federal Food, Drug, and Cosmetic Act requires that certain drug and biologic submissions be submitted in electronic format within 24 or 36 months after FDA's issuance of final guidance on that topic.

On May 15, 2015, FDA published the final "Guidance on Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD [Electronic Technical Document] Specifications." The Guidance states that submissions for NDAs, ANDAs, and BLAs must be submitted in electronic format using the Agency's online gateway beginning on May 15, 2017, and that IND submissions must be submitted in electronic format beginning May 15, 2018.

FDA considers Drug Master Files (DMFs) to be submissions to an NDA, ANDA, BLA, or IND, and therefore to fall within the scope of requirements set forth in Section 745A(a). Thus, all DMF filings must be submitted electronically beginning on May 15, 2017. DMFs are voluntary filings by suppliers to allow them to protect their confidential information when that confidential information is necessary to support FDA's review the corresponding drug or biologic application (NDA, ANDA, BLA, or IND). For example, drug packaging material suppliers can provide information directly to FDA in a DMF and authorize FDA and drug manufacturers individually to reference that DMF in submitting and considering applications for FDA approval.