FDA Releases Guidance on Electronic Submissions

07 August 2019

BioPharm International

The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.
FDA released guidance on July 16, 2019 that describes how applicants should organize the content they submit to the agency electronically. The guidance applies to all submission types   under section 745A(a) of the Food, Drug, and Cosmetic (FD&C) Act. The guidance also references technical specification documents and the Electronic Common Technical Document Conformance (eCTD) Guide. Specifically, the guidance implements the electronic submission of 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 Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

A previous version of this guidance, published in May 2015, indicated that NDAs, BLAs, ANDAs, and master files were to be submitted electronically in eCTD format starting on May 5, 2017 (May 5, 2018, for commercial INDs). In response to industry concerns, however, FDA extended the implementation date for drug master files (DMFs) to May 5, 2020. This new revision modifies previous versions by including exemptions for Type III DMFs. The guidance has also been updated to include the criteria identifying those types of submissions that may qualify for a long-term or short-term waiver from the eCTD submission requirement and instructions on how to submit a waiver request.

Comments on the draft guidance will be accepted until Sept. 16, 2019.

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