20 February 2012

FDA News Alert: Notable Progress’ in FDA Reception of Marketing e-Submissions

FDA’s ongoing transition to universal (and, ultimately, mandatory) acceptance of regulatory submissions for advertising/promotional submissions in electronic format, although the process is currently more advanced for submissions related to biologic products than for drugs. Details concerning the status of the agency’s electronic submissions initiative were discussed at the 2012 Marketing Conference sponsored by the Drug Information Association (DIA) 2/1.
According to CDER Office of Prescription Drug Promotion associate director Marci Kiester, the process of transitioning to electronic submissions for regulatory materials may be said to have begun in 2008, with FDA’s acceptance of the electronic Common Technical Document (eCTD) — an ICH standard for regulatory submissions now recognized not only by FDA but by counterpart Canadian, Japanese, Swiss, and European regulatory authorities. Kiester noted that Module 1 of the eCTD pertaining to advertising/promotional submissions has recently undergone some modification in order to make it more user-friendly for sponsors, and more useful to agency reviewers. Specifically, these changes include additional sub-headings to elements of the document, affording more “granularity” to the information provided and, further, allowing submissions to be amended or updated more easily. With modification of Module 1, supportive files will no longer reside in the eCDT folder, but will be referenced at a Web location, Kiester said.
Although the agency components responsible for reviewing advertising/promotional materials are currently receiving electronic submissions, paper submissions remain acceptable and, indeed, still constitute the majority of submissions. A 10/26/11 Federal Register notice solicited comments on the architecture/specifications of the revised Module 1 draft, and a total of more than 200 comments were received. Kiester indicated the agency is now reviewing these comments prior to a planned 9/18/12 public meeting at which the module will be discussed with stakeholders. She said a time-frame for full implementation of the electronic submission initiative has not been determined, though she “hopes it might be possible early in 2013.”
To find more information please use the below mentioned FDA webpage

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