Frustrated and overworked businessman burying his head uner a laptop computer asking for help

Approvals Appear to Inch Up in February but EI Issues Still Result in an Anemic Month

According to the FDA all Approvals list (here), approvals for February 2018 did inch up a bit to 29 full approvals and 4 tentative approvals, but they are still far below the OGD norm. We had previously predicted that it would take about 3 months before the approval train got back on track, and now we know that it is the elemental impurities (EI) issue for certain that has dragged down the monthly average of approval actions on ANDAs.

Until the official figures are out, I hesitate to provide any figures on FY estimates and, even then, once the approvals get back to their usual pace, we hope that that figure (whatever it may be) will move skyward before the end of FY 2018.

I can tell you one thing, this blog started mid-way through June of 2013 and, in all of this time, I have never received so many comments on any other blog post.  Yesterday, I did hear from someone involved early on in the development of the ICH Q3D document on EIs, and they noted that in all of the testing that was reviewed over the years leading up to the issuance of the document, and not a single product failed the permissible daily exposure limits.  Perhaps another reason to accept a commitment to move products to approval? Just saying!