WORLD OF GENERIC DRUGS MODULE

FAQ

1. There are two queues, expedited and regular. What happens if the expedited queue keeps filling up and the reviewer never gets to the regular queue? How is work assigned so all applications are dealt with fairly?

   1. Unless there is a circumstance where the Office of Generic Drugs will expedite an application for a specific reason, "first in, first out" is what OGD chooses to do.

      For example, if there are three 140-day applications, then three reviewers might get one each. If they are sister applications, the same reviewer will get two of them. But the process is still, "first in, first out." Most of the time, the regular queue does not show huge numbers of applications; therefore, applications are assigned one at a time. OGD has never experienced receiving say a bulk of 10 applications that then wait in a queue. The next application in line will be assigned to an available reviewer.

2. Does an applicant submit a motivation letter for expedited review?
   1. Yes, the applicant needs to request an expedited review from OGD. The letter will list reasons why an expedited review is necessary. OGD will decide whether the application can be expedited under FDA criteria. An expedited review will then get priority.