Congress finally receives legislation on FDA
This article was originally published in Clinica
Executive Summary
After months of hearings, conferences and reports, legislation on major changes in the FDA drug and device approval process has been introduced to Congress. Presenting the FDA Modernisation Act of 1995 (HR 1742) on June 6th, congressman Ron Wyden told colleagues: "It is crucial ... that the federal regulatory system so integral to the development and commercialisation of new [drugs and medical devices] changes, improves and advances in step with [the] technological revolution" which is now occurring.