The Office of Generic Drugs released nineteen new and ten revised bioequivalence recommendations today. The Federal Register Notice (here) lists two tables with the new and revised recommendations as presented below:
There are always concerns, when an existing guidance is revised, as to how it might impact planned bioequivalence testing or studies already submitted in ANDAs and, for that matter, ANDA products that may already be approved. Take some time to review the revisions and contact the Office of Generic Drugs if you have any questions regarding the impact of the proposed revisions to a specific recommendation. All of the actual recommendations can be accessed here.
