e martë, 2 tetor 2007

Bush Signs MDUFMA Reauthorization Bill Into Law

President Bush signed the FDA Amendments Act, H.R. 3580, into law Sept. 27, reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA) and granting the FDA additional authority.
FDA Commissioner Andrew von Eschenbach said in an FDA conference call that the timing of the law’s passage is important as it eliminates the possibility of reductions in the agency work force.
Reauthorization of MDUFMA will provide, in addition to appropriated funds, a revenue of $287 million by October 2012, Randall Lutter, the agency’s deputy commissioner for policy, said.
The reauthorization will ensure that the FDA centers have the resources needed to conduct complex and comprehensive reviews of new devices, von Eschenbach said.