Posted 03 November 2017
By Michael Mezher
The US Food and Drug Administration (FDA) on Friday issued a revised version of its draft guidance on the information that must be pre-submitted in order to receive a priority review for an abbreviated new drug application (ANDA).
As part of the negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA II), FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a pre-submission facility correspondence (PFC) at least two months ahead of their ANDA submission. FDA would then use that two-month period to determine whether facility inspections are needed, and when they are, to begin inspection planning earlier in the review process.
But since drafting the original version of the guidance, the FDA Reauthorization Act was signed into law, bringing with it some changes to the information the agency can collect as part of a PFC.
According to FDA, FDARA permits the agency to "utilize the existing process for submission of ANDAs (including electronic Common Technical Document (eCTD) submission format) for the pre-submission of facility information and avoids duplicative effort by applicants that would have been required if the relevant facility information had to be submitted as identified in the original draft guidance."
Under the previous version of the guidance, FDA would have required applicants to submit their PFCs electronically via the agency's electronic submission gateway (ESG) in a non-eCTD format, whereas the revised version requires the submission to be in eCTD format.
As such, the new version of the guidance includes a table detailing the specific eCTD sections that must be included in a PFC. FDA also notes that for prior approval supplements (PAS) and ANDA amendments, applicants only need to include the eCTD sections that are relevant to those types of submissions.
Because some companies may have already been preparing PFCs in a non-eCTD format, FDA says it will allow sponsors to follow either version of the draft guidance until 6 December 2017.
Additionally, FDA says it will still consider comments submitted to the original version when finalizing the guidance, so that stakeholders do not have resubmit their comments.
It's unclear whether the revisions will ease generic drugmakers concerns about the priority ANDA program. Comments from the generic drug industry group the Association for Affordable Medicines AAM on the previous version called the program "basically inoperable" and said it would require companies to submit a "mini ANDA" ahead of their actual submission.
Generic drugmaker Teva also commented on the earlier version saying the guidance "exceeds the details included in the commitment letter."
Revised Draft Guidance, Federal Register Notice