While many in the industry have complained about the handling of controlled correspondences (CCs), the numbers of CCs submitted in a given month continues to rise as it has every fiscal year since the process was formalized under GDUFA I. Complaints of non-answers to questions, unclear answers, and just flat-out denials of acceptance of CCs have frustrated industry members. Well, now that the OGD has finalized the guidance entitled Controlled Correspondence Related to Generic Drug Development (here), perhaps some of those issues will be resolved.
The guidance originally appeared in September 2015 and was “issued as part of FDA’s implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA I).” It goes on to say it was “issued to incorporate program enhancements related to the review of controlled correspondence to which FDA committed, and industry agreed, as part of the reauthorization of GDUFA (GDUFA II).”
Revisions to the draft guidance include:
- Clarification of the FDA’s practices regarding controlled correspondence that is related to a pending petition
- What information should be submitted with a request related to an inactive ingredient
- When the FDA may determine an inquiry is a complex controlled correspondence
- The recommendation that requestors submit their controlled correspondence through the CDER Direct NextGen Collaboration Portal
The guidance also includes tips on how to handle questions related to BE issues and clarifications or alternative approaches a firm may propose.
Standard goal dates for responses to CCs have not changed but the following goal was added based on the GDUFA II commitment letter:
“FDA will review and respond to 90 percent of submitter requests to clarify ambiguities in the controlled correspondence response within 14 calendar days of FDA’s receipt of the request.”
We are not sure whether the OGD counts these clarifications as new controlled correspondences which, of course, may be contributing to the soaring totals of CCs that the OGD is receiving. In addition, we wish that the OGD would consider telcons to resolve clarifications of CC responses as it could save the Agency valuable time, especially when the response from the Agency is nonresponsive to the question posed or when a firm asks a specific question on a guidance and the response to the CC is to refer the questioner to the guidance that the questioner is asking about. This may be a GDUFA III wish list item since the OGD has not shown any interest in employing this mechanism to resolve such issues.
Progress is being made but, in this observer’s view, there is still a lot of work that must be done to address the problems that crop up with regard to CCs.