Senate Passes Bill That Includes MDUFMA II

The Senate yesterday passed the FDA Revitalization Act, which includes the new version of MDUFMA, 93-1. The bill is getting more coverage in the media for its drug-industry reforms, particularly concerning safety issues, as evidenced by the piece in today's New York Times. But it has significant impact on the device industry, too.The language in the Senate bill keeps intact the entire agreement negotiated between FDA and the device industry over user fees, performance goals, and such, according to an AdvaMed release.It's now up to the House to produce companion legislation. A timetable for that has not been made public.