Office of Generic Drugs Opens The Door a Bit to Get Timely ANDA Updates
[Posted on: Monday, August 20, 2015]

FDA released a new internal policy on 17th Aug whereby sponsors of ANDA applications will soon start receiving timely updates regarding the status of their application’s review. Under this new policy the Regulatory Project Managers (RPMs) at Office of Generic Drugs (OGD) will respond to any status inquiries from authorized representatives of the companies within 2 business days. By moving the responsibility of responding to queries to RPMs instead of reviewers, team leaders, discipline project managers, division directors, deputy division directors, other CDER management, or any other CDER staff, FDA intends to make the process more efficient. This times apply only to status of review; for all other inquiries regarding technical aspects and regulatory guidance, FDA still requires the sponsors to preferably use the Controlled Correspondence process. Under the controlled correspondence process, FDA aims to respond to all usual information requests within 2 months from the current time of 4 months to respond to about 70% of the inquiries. As people familiar with the controlled correspondence can vouch, this method of interacting with the OGD is very frustrating as responses to any non-routine inquiries could take a very long time. For very special cases, OGD is willing to grant meetings but that process is very limited with only about 20% of requests being granted. The new policy now provides three mechanisms for getting responses to questions about generic drug applications: for status of review contact RPM, for most routine non-status questions use Controlled Correspondence, and for very special cases try getting a meeting with OGD reviewers. This slight opening of door will be welcome as most concerns are about finding out when FDA is expected to make a decision on a given application but hope OGD will open its doors further and provide a more clear guidance on meeting requests as well.

Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research