Refuse-to-Receive Guidance Revision 1 Issues for Generic Drugs

The newly revised Refuse-to-Receive (RTR) Guidance for ANDAs was issued on May 26, 2015 and was published on the FDA website the same day.  A look at the revised Guidance does not reveal any real changes of substance, but rather includes reorganization of some of the information and revises references to the newly created Office of Pharmaceutical Quality (OPQ) and the new organizational units under its direction.  Major changes from the draft were outlined in a previous post here when the first final version initially issued on September 16, 2014.  The newly revised guidance can be found here.

The RTR Guidance is an important roadmap to filing a complete application, but in no way assures that the application will meet all Office of Generic Drug (OGD) requirements, as the target continues to move as OGD and OPQ continually refine their expectations.