## FDA: required BE between early phase and Phase 3 formulations? [Regulatives / Guidelines]

Dear All,

Sorry for the naive and quite basic question, but I did not succeed in finding a clear and definite answer in any of the FDA guidances :

Is FDA requiring a formal BE demonstration for bridging the early phase with the Phase 3 formulations?
If so, what would be the required actions in case the Phase 3 formulation is not perfectly bioequivalent to the previously used formulation?

Kind regards,
Fabrice