FDA Extends Electronic Submission Deadline for Type III Drug Master Files

The FDA issued final guidance on electronic submissions of drug master files, giving sponsors of Type III DMFs for packaging materials an extra year before submission requirements kick in.

The guidance includes submissions for ANDAs, NDAs, BLAs or INDs and other master files relevant to biologics.

Under the new submission timetable Type III drug master files must be submitted in the format beginning May 5, 2019.