Regulatory Open Forum

Hi, I am hearing from a colleague that they have submitted Type II DMFs without including any QOS/summary content in Module 2.3, but I can't find any guidance/justification for this. They are also wanting to remove the M2.3 content from an existing DMF that was already submitted to the FDA. Thanks for any advice! To date, there are no planned ANDAs for this product but there could be much further down the road. For now we are not considering that it will be handled under GDUFA though.

Dear Anon,

Per FDA 2019 draft guidance on DMF and subsequent 2022 workshop presentation and discussion, Module 2.3 is needed to submit summary of Module 3 information for DMF. Please let me know if you have any questions. Thanks. Gene Zhu

Attachment(s)

DMF_draft guidance.pdf   195 KB 1 version