ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions Guidance for Industry

ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions Guidance for Industry

On August 18, 2017, the President signed the FDA Reauthorization Act (FDARA) into law. FDARA includes statutory provisions that provide for the expedited review of qualifying priority abbreviated new drug applications (ANDAs) by enabling the “pre-submission” of certain information prior to submission of the application itself. In particular, the statute allows applicants seeking to take advantage of the shorter goal date provided under this section to pre-submit sections of their ANDA containing information regarding manufacturing facilities and bioequivalence and 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In light of the new statutory provisions, FDA intends to revise the previously issued draft guidance document concerning pre-submission of facility information.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. 

If you have any specific questions about submitting a pre-submission associated with your priority ANDA, you can email PFC-Inquiries@fda.hhs.gov. To provide general comments regarding the PFC process as outlined in the draft guidance, you can submit a comment to docket number FDA-2017-D-3101 on regulations.gov. The new guidance will be published to the same docket and a comment period will be provided. It is not necessary to resubmit comments already submitted to the docket.