Health Care Trends: FDA Amendments, Changes in Store
The FDA Amendments Act of 2007, siged into law in September, proposes many changes designed to improve drug and device safety and efficiency as well as make the approval process more transparent to the public.
You may also be interested in...
The FDA is requesting Congress to reauthorize the Medical Device User Fee and Modernization Act of 2002 (MDUFMA I). In MDUFMA II, the FDA is proposing to increase user fees for processing medical device applications by 31%. That means the industry would end up funding $287 million over the next five years to supplement money appropriated by Congress.
Robust natural history data sets with well-chosen outcomes are fundamental in Aetion’s regulatory feasibility tool for real-world evidence, built through analysis of US FDA case studies and guidance.
Ideally, the studies would be underway at the time of approval, as the US FDA’s new authority allows, but Office of Therapeutic Products Director Nicole Verdun sys there will be exceptions.