New and Revised Product-Specific Bioequivalence Guidances Announced

In the prepublication page of the Federal Register Notice (here) published today, OGD announced 28 new bioequivalence recommendations and revised 53 previously issued recommendations.  While the new and revised guidance documents appear on the listing of Product-Specific Guidances for Generic Drug Development (here), the links to the new and revised documents were not yet active at the time of this writing. They may show up later in the day or tomorrow.

OGD keeps pumping out the BE recommendations and revisions to try to keep up with new science while targeting newer NDA approved products at least two years before their patent expiry and requests from industry for other older products for which no recommendation has yet been given.

If you have a product in development or one that is on track for future development, be sure to continuously check the OGD recommendations to ensure your greatest chance of success in establishing bioequivalence of your product to that of the reference listed product