When should a timeliness dispute resolution request be presented?
The purpose of a timeliness dispute resolution request is to ensure timely completion of the relevant review, rather than to impose any sanction on the reviewing Center. In keeping with this perspective, OCP recommends that dispute resolution requests be presented after the relevant deadline has been missed, and before the reviewing Center has completed its premarket review. For example, if a relevant performance goal states that a particular action is to be taken within 90 days, and the Center completes the review on day 93, a timeliness dispute resolution request presented on day 95 would do nothing to further the goal of obtaining a timely review. As noted above, when a combination product is reviewed under two marketing applications, OCP would consider the time frames associated with each type of application. Applicants with combination products reviewed under two types of applications may submit dispute resolution requests for one of the applications, even if the time frame for th
