The FDA announced the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications.
Teva Pharmaceuticals Industries Ltd., of Jerusalem, said it concluded negotiations with the U.S. government over violations of the Foreign Corrupt Practices Act (FCPA). Following Teva's voluntary worldwide investigation into business practices, Teva and the U.S. Department of Justice and SEC have agreed to a resolution to resolve previously disclosed investigations into conduct relating to three countries – Ukraine, Mexico and a guilty plea by the subsidiary in Russia. The resolution includes a deferred prosecution agreement, the implementation of a temporary independent compliance monitor, and previously reserved payments totaling $519 million. The resolution involves conduct occurring in the past, and none of the employees involved in the improper payments are still employed by Teva, including in Russia where the entire leadership team was replaced in 2013, the company said. None of the conduct in question involved Teva's U.S. sales.