Today, the FDA issued twenty-six new and six revised Product Specific Guidances (PSGs) (here). PSGs provide the Agency’s current thinking on acceptable methods for demonstrating bioequivalence between the Reference Listed Drug or the Reference Standard designated by the Agency (if the RLD is no longer available) and the proposed generic product.
These latest PSG additions cover a wide variety of dosage forms and products. If you have any products on the list in development, be certain to evaluate your development program to either incorporate the FDA-recommended bioequivalence testing or, if you have begun BE testing using an alternate methodology, contact the OGD and request a meeting to determine whether your approach may be acceptable. The same goes for PSGs that are revised. If the changes are minor then no problem, but, if the changes are major or critical, you also may need to discuss the impact that the changes will have on your planned, pending, or approved application.
Some of the changes, like the addition of an alternate in vitro methodology rather than an in vivo or BE study with clinical endpoints, should be welcome. But be in a constant state of vigilance to keep from being blindsided when a new or revised PSG is issued for your product that has been approved, is pending, or in development.
