Learning the GDUFA II Language

Although the generic industry has come a long way in terms of Quality-by-Design or the desired space, it is still in early stages when it comes to Dates and Abbreviations as they relate to GDUFA.  It has been a little overwhelming to the participants of this year’s Association of Accessible Medicines (AAM) Fall Technical Conference in Bethesda, MD to take in all the goals (abbreviations) and the milestones (dates).

FDA is serious about the importance of regulated industry having a clear understanding of the commitment letter published for GDUFA II.  To make the point, every presentation during the conference included a slide with the respective language from the commitment letter.  In addition, Kathleen (“Cook”) Uhl, Director, Office of Generic Drugs, urged the industry over and over again to read the commitment letter and understand the goals.

So, let us see if we can get some of this right.  Under GDUFA II, Regulatory Project Managers (RPM) will use Discipline Review Date (DRD) to provide reviewers clarity on when primary reviews are needed by discipline.  By Mid-Review Date (MRD), all discipline reviews should be turned over to the discipline Project Managers (PMs) for inclusion in the Discipline Review Letters (DRL).  FDA will issue appropriate Information Requests (IR) and/or DRLs from each review discipline as soon as the discipline has completed its review by the Discipline by Mid Cycle Date (MCD).  All reviews must have been completed by Owner Due Date (ODD) to allow action letter Complete Response Letters (CRL), Approval (AP) letter, Tentative Approval (TA) issuance in advance of the GDUFA II goal.

What does all of this mean for the industry?  According to FDA officials (from OPRO and ORO), the defined shorter goals for gaining priority review with Pre-submission Facility Correspondence (PFCs) (although forcefully questioned by the industry) and the use of early intervention by FDA should lead to increased business certainty, as review times and communications are better defined.  This is likely to provide opportunities for applicants to make minor updates, corrections, etc., and gain a one-cycle approval even for applications not granted priority review status.  The GDUFA II commitments will permit reviews of ANDAs to begin earlier in the review cycle.  Applicants will receive preliminary thoughts on their application at about the mid-point of the review period, so that applicants may have an opportunity to resolve issues during the review cycle.  Applicants may receive one or more IR letters throughout the review cycle and it may come soon after acceptance of the ANDA.  Applicants will receive at least one DRL for each discipline around the midpoint of the review cycle.  Unresolved IR or DRL items may appear in a subsequent CRL letter.  The goal is to improve review efficiency and reduce review cycles.

For now, the industry representatives not directly involved in the GDUFA II negotiation process are trying to pick up the lingo and figure out how these will translate to meeting goals.  FDA has always been good at acronyms and GDUFA II has opened the floodgate!