FDASIA 2012 Impact on Electronic Submission Requirements of Drug, Biologic, and Device Companies

The FDA Innovation and Safety Act (FDASIA) of 2012 became effective 1 October 2012.  The act mandates that applications to CDER, CBER, and CDRH be submitted electronically.  While the mandates will take 24 to 36 months to become effective, sponsors will be required to pay user fees under PDUFA V, MDUFA III, and GDUFA beginning October 1 for new submissions, and to clear up the backlog of unapproved ANDAs and unreviewed DMFs. This means that sponsors will pay the user fees and receive none of the benefit of the review timelines contained in FDASIA unless their applications use eCTD for drugs and biologics, and Electronic Copy for devices.  This applies to sponsors submitting Drug Master File Type II (DMF-II) for drug product, ANDAs, NDAs and BLAs, and device companies submitting all forms of pre-submissions and submissions to CDRH.