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FDA Issues Guidance on Regulatory Submissions in Alternate Electronic Format, Including Type III DMFs

March 31, 2020

Earlier this month, the Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “Providing Regulatory Submissions in Alternate Electronic Format.”  This Agency guidance describes the alternate electronic format that FDA is recommending for Drug Master File (DMF) submissions that are exempted (or waived) from electronic Common Technical Document (eCTD) formatting, such as Type III DMFs for drug packaging and drug packaging components.  For more on the exemption from eCTD requirements for Type III DMFs, see the PackagingLaw.com article, “FDA Permanently Exempts Type III DMFs for Drug Packaging Materials from eCTD Format Requirement.”

The draft guidance on submissions in alternate electronic format details, among other items, the particular submission forms to be used, pre-submission considerations, and information about the structure and file format.

FDA is accepting written or electronic comments on the draft guidance until May 11, 2020.  Electronic comments should be submitted to: https:/www.regulations.gov.

Written comments should be submitted to:

Dockets Management Staff (HFA-302)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852