The Department of Justice (DOJ) and its federal partners are being very vocal about turning up the heat on compounders and dietary supplement manufacturers and marketers in 2016 and beyond. 2016 is guaranteed to be a record year for enforcement actions against manufacturers of these products that are not in compliance with the regulatory framework governing their manufacture and distribution.
FDA recently released a revised draft Guidance outlining its new thinking on the bioequivalence requirements for paliperidone palmitate, representing still another BE guidance revision for a long-acting product, but this time for a long-acting parenteral suspension of this product for schizophrenia. The original draft BE Guidance document for this injectable suspension was issued in August 2011.
December, the last month of the calendar year, may (we hope) represent the new normal in the approval of generic drugs. But there may also be signs of concern regarding submissions on the horizon. The Office of Generic Drugs (OGD) had a modern day record in December with 79 full approvals and 20 tentative approvals for a total of 99 approval actions for original ANDAs for the month.
