Cannabis Manufacturers Should File DMFs To Help Drug Development: FDA
(Thursday, September 17, 2020]​
Cannabis products manufactured for non-FDA regulated purposes can also be used to develop pharmaceutical products. However, most cannabis products are manufactured using proprietary methods which the manufacturers would not share with pharmaceutical developers. In an email this week, FDA advised such manufacturers to file Drug Master Files (DMFs) that could be used to help drug developers with their IND and NDA applications. Information submitted in DMFs is held completely confidential by FDA and not shared with anyone. The owners of the DMF can authorized FDA to review the contents of their DMF in support of an IND, NDA, or ANDA. In that case, FDA will internally review the DMF and let the developers know if the information is sufficient or deficient in support. In no case does FDA disclose the contents of the DMF to the IND holder. DMFs are routine documents in the pharma and biotech industry but relatively unknown in less-regulated industries like the cannabis product manufacturers. However, use of DMFs is not limited to the drug and biologic manufacturers but practically anyone can use these to share proprietary information without disclosure. And IND, NDA and ANDA holders cannot move products from non-regulated cannabis space to the pharmaceutical space without DMFs. And with no FDA fees associated with filing DMFs or issuing cross-reference authorization, filing a DMF is a no-brainer.