One of the most commonly used methods of extracting guidance on various issues from the Office of Generic Drugs is the Controlled Correspondence (CC) process.
While this process is often maligned because of the high bounce back rate due to minor formatting or technical issues, the process is one of the only ways to obtain specific answers from the OGD on developmental, process, or administrative concerns.
The guidance, titled Controlled Correspondence Related to Generic Drug Development, can be found here. This guidance finalizes the guidance of the same name that was issued in draft on December 22, 2022. The Agency notes the following:
“Changes from the draft to the final guidance include updating the guidance to clarify the role of a cover letter to a controlled correspondence; clarify that authorized agents submitting controlled correspondence should include the name of and contact information for the generic drug manufacturer or related industry they are representing; and explain that FDA intends to alert requestors whether their inquiry is a level 1 or level 2 controlled correspondence and if FDA changes the level of the controlled correspondence (e.g., from level 1 to level 2) during substantive review. In addition, editorial changes were made to improve clarity.”
Be acutely aware of this final 24-page document and study it well as understanding its sometimes-detailed requirements may help you properly navigate the process and get your CC accepted on first submission. Be very specific in your requests and phrase your questions in a manner that will help ensure that you get a useful answer to the question you describe in your CC. The process is not always as straightforward as you might think, especially if you are doing it for the first time. Know who can submit a CC, what types of questions are appropriate for a CC, properly identify the discipline to which the CC is to be routed, and (above all) don’t ask questions of more than one discipline in a single CC. For instance, if you have one question about a reference standard and one about a bioequivalence study design issue, submit one CC for each of the questions, otherwise you may get a return-to-sender response asking you to submit two separate CCs. If you do, please put your frustrations aside as this is how the game must be played at this time.
