The Lachman Blog

  In December 2014, we did a story on First-Time generic approvals for FY 2013 (here). In that post we noted that, for FY 2013, the Office of Generic Drugs (OGD) reported approving 108 first time generic products.  This information was taken from OGD’s Generic Approval reports (here) and navigating to 2013’s First-Time list (here). […]

I have been attempting to compare backlog numbers, receipts of new ANDAs and applications that are in the hands of industry for response to FDA’s Complete Response Letters (CRLs), and it has been quite a struggle.  But I think I’ve got it now, and I hope I am right! The way the “backlog” used to […]

We are not entirely sure how FDA makes its decisions to revise a BE Guidance document, but we are clearly in the dark as to how and when the FDA decision to require firms to repeat BE studies using the revised recommendation are made. I am sure that FDA will (as they have with certain products) tell a firm when it is absolutely necessary to repeat a study using a new BE recommendation, but FDA does not do this in all instances. What are the criteria for FDA’s decision making process?

  The Office of Generic Drugs (OGD) received 55 original ANDAs in April 2016, the third highest number of receipts in the 8 months of FY 2016.  The two higher months were December 2015 (180) and March 2016 (114).  OGD has received a total of 527 ANDA or an average of just a little over […]