FDA to Revise Pre-Submission Draft Guidance Due to GDUFA II

Now that the FDA Reauthorization Act of 2017 (FDARA) is law, the US Food and Drug Administration (FDA) said Tuesday it will revise previously issued draft guidance on the pre-submission of certain information for abbreviated new drug applications (ANDAs).

FDARA, which was signed by President Donald Trump last Friday, includes statutory provisions that will expedite the review of qualifying ANDAs by allowing the “pre-submission” of certain information prior to submission of the application.

According to the goals letter of the second iteration of the Generic Drug User Fee Act, FDA will review and act on priority original ANDAs, amendments and prior approval supplements within eight months of the date of submission if the applicant submits a pre-submission facility correspondence two months prior to the date of ANDA submission and the correspondence is found to be complete, accurate and remains unchanged.

FDA notes that companies can pre-submit sections of their ANDAs containing information regarding manufacturing facilities, bioequivalence, clinical sites and organizations.

"In light of the new statutory provisions, FDA intends to revise the previously issued draft guidance document concerning pre-submission of facility information. The revisions will be intended to take the new statutory provisions into account and to establish policies necessary for expedited review of priority submissions," FDA said.