New and Revised Bio Guidances Issued by OGD

The Office of Generic Drugs is publishing thirty-one new and fifteen revised bioequivalence guidances according to the pre-publication notice that appeared in the Federal Register today (here).  The official FR notice is scheduled to publish on September 17, 2019, but a quick check reveals that the new and revised guidance documents are already available today (September 16th) on the Product-Specific Guidances for Generic Drug Development (here).

In the past, the new and revised guidances appeared at the beginning of the above-referenced list by category; now, however, they are simply incorporated into the alphabetical lists.  Having the FR notice handy will simplify your review of the new and revised guidance documents.  Remember, if a revised guidance appears for a product that is currently approved and marketed, or pending with the OGD, or one you are working on for future submission or are about to submit to the Agency, please check carefully to see whether the revisions of the product-specific bioequivalence recommendations will impact the work you have done or could call into question a product or products that you already market.