Earlier this month, the US Food and Drug Administration (FDA) revised its draft guidance detailing the information that must be pre-submitted in order to receive a priority review for an abbreviated new drug application (ANDA).
As a condition of reauthorizing the Generic Drug User Fee Amendments (GDUFA II), the agency has 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 before submitting an ANDA.
During that two-month period, FDA would determine the need for facility inspections in an effort to begin inspection planning earlier in the review process.
Changes posed by the FDA Reauthorization Act
The FDA Reauthorization Act (FDARA), which was signed into law after the original version of the guidance was issued, brings a number of important changes to the kinds of information FDA can collect as part of a PFC.
According to the agency, FDARA permits regulators 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that would have been required if the relevant facility information had to be submitted as identified in the original draft guidance."
The earlier version of the guidance required applicants to submit PFCs electronically via FDA's electronic submission gateway (ESG) in non-eCTD format. The new revision now requires submissions be made in eCTD format.
What this means for ANDA applicants
• The new version of the guidance offers a table detailing particular eCTD sections that must be included in a PFC.
• For prior approval supplements (PAS) and ANDA amendments, applicants only need to include the eCTD sections that are relevant to those types of submissions.
• FDA says it will allow sponsors to follow either version of the draft guidance until 6 December 2017, recognizing that some companies may have already been preparing PFCs in a non-eCTD format.
• The agency 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 remains to be seen whether or not these changes will ease concerns voiced by generic drugmakers regarding the priority ANDA program.
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