November 2016 OGD Stats Updated

OGD posted additional statistics relative to metrics that it routinely tracks by month.  Included in these numbers are data on Refuse-to-Receive (RTR) actions, supplements received, controlled correspondence, etc.

All of FY 2016 monthly RTR actions were in the double digits except for September, which saw only 9 RTR actions.  Well, 2017 seems to be starting in the right direction as the October and November RTR actions were reported at 9 and 8. 

More Bioequivalence Guidance Documents Issued by OGD

The Office of Generic Drugs (OGD) has been busy in the bioequivalence arena as evidenced by its issuing of 31 new recommendations and revising 17 previously issued recommendations.  The list of new and revised recommendations can be found here.

As always, there are some specific recommendations that are of note while others are standard bioequivalence recommendations.