Yesterday US FDA has published a new guidance “M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use – Guidance for Industry”. FDA has addressed recommendations for eCTD 4.0. The guidance also provides separate tables describing the recommended granularity for paper and eCTD v3.2.2 submissions, and for paper and eCTD version 4 submissions.

As well, in another new guidance, FDA clarifies that for DMF information submitted in an ANDA, electronically submitted DMF information will be considered readily available if the Right of Reference letter clearly indicates the exact location of the relevant information within the DMF – the eCTD sequence and submission date.