Comment from Michael Strauss
AnonymousOtherIndividual
Summary: A pharmaceutical consultant notes that the proposed M4Q(R2) structure omits the compatibility of installation materials (like lines and tubing) which were present in the old eCTD format. The commenter requests that the FDA clarify how this change will affect IND filings and provide a timeline for updating the eCTD structure.
As a consultant who has written numerous INDs, CTAs, IMPDs, BLAs, MAAs and NDAs, I did not see any mention of compatibility of instillation materials, such as lines/tubing, etc. that are used for many products. This had a place in the old eCTD format, but is not listed in the proposed M4QR2 structure.
Further, it would be good for FDA to publicly acknowledge how this new format will change IND filings and format, as well as the timing for update of the eCTD structure to a compatible one.