Yesterday, the Office of Generic Drugs released twenty-four new and thirteen revised Product Specific Guidances (PSGs) with recommendations for conducting studies necessary to establish bioequivalence between test and reference products.  Of course, the revisions might spell trouble for applicants that have already commenced testing according to the original guidances, but this has been a bone of contention for many years between the OGD and industry.  Some of the discussions on this have revealed that changes made by the FDA after studies have been completed by firms developing products could force firms to abandon projects, potentially leading to shortages on the market.

The OGD reports the following regarding the metrics of the guidances issued:

  • Twenty-four new and thirteen revised PSGs
  • Fourteen PSGs for complex products (eleven new and three revised PSGs), nine of these for products with no approved ANDAs (eight new PSGs)
  • Twenty-six PSGs for products with no approved ANDAs (eighteen non-complex and eight complex products)
  • New PSGs for products used as treatments for diseases or conditions, some of which were supported by Generic Drug User Fee Amendments (GDUFA) science and research

The FDA boasts that two guidances were issued for a product used to treat Type 2 diabetes, exenatide subcutaneous suspension (RLD Bydureon, NDAs 022200 and 209210), one for a product for breast cancer, Palbociclib tablet (RLD Ibrance, NDA 212436), and one for a product for adult periodontitis, Chlorhexidine gluconate tablet (RLD Periochip, NDA 020774).  The full list of new and revised guidances may be found here.

In addition, the Agency also updated its list of guidances that it intends to issue as soon as work is completed on the document.  This list can be found here.

Have a look to see what is new!