The chief executives of several of the world’s biggest generic-drug makers have pledged to bring a “holistic approach” into user-fee negotiations with the FDA. In a panel discussion Feb. 18 at the Generic Pharmaceutical Association annual meeting in Orlando, the heads of Teva Pharmaceuticals USA, Mylan, Sandoz and others said they would work with the agency to adopt a unified approach before talks begin, but would expect the FDA to offer guarantees as well.
Washington Drug Letter