As you know, the issue of controlled correspondence has historically been a contentious issue between the Office of Generic Drugs and the generic industry mostly related to timing of the response. The situation is not different today but the contention addressed today is more about the new definition of controlled correspondence and who may submit them. However, with the GDUFA goal of 70% responses within 4 months for FY 2015, moving to 70% in 2 months in FY 2016 and then to 90% in 2 months in the last year of GDUFA the issue of timeliness may no longer be as much of a concern.
As you can see, OGD has met its goals for each month’s submission in FY 2015.
More importantly, as described in the chart below, OGD has whittled away the backlog of controlled correspondence submitted pre-year 3 of GDUFA, for which there were no goals. Today there are only 175 that have not yet been addressed.
While this represents remarkable progress that OGD has made in the area of responding to controlled correspondence, there are still important differences in opinion between FDA and industry regarding certain issues that will likely be addressed in GDUFA II. For instance, industry is not happy that the controlled correspondence goal dates do not apply to questions posed to OGD relative to drug product specific bioequivalence requirements. In general, however, progress is excellent and we will have to see what changes may be in the works for controlled correspondence.