12 May 2012
Mandatory electronic Submissions to FDA?
Energy and Commerce Committee, unanimously approved the “Food and Drug Administration Reform Act,” H.R. 5651, by a vote of 46 to 0. The legislation ensures continuation of various FDA programs, including the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA), and authorizes new user fee programs, the Generic Drug User Fee Act (GDUFA) and Biosimilars User Fee Act (BsUFA), to facilitate the review and approval of life-saving and life-improving drugs and medical devices. As part of the agreement, FDA will commit to certain performance goals, fostering more interaction, predictability, and certainty between industry and FDA.
Title VI: FDA Administrative Reforms - Section 603 of the bill mentioned about the mandatory requirement of an electronic submissions for NDA, BLA, IND, ANDA, Type II DMFs, All Medical device submissions and Biosimilar submissions. The timeframe is 24 months after issuance of the final guidance.
“Title VI: FDA Administrative Reforms - Section 603: This section would require electronic submission of drug, generic drug, biologic, and biosimilar applications following issuance of a final guidance by the Secretary.”
format submission will be used for drugs & biologics submissions and electronic copy (eCTD format without XML backbone) for medical device submissions.