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.
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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.
Lilly announced it signed strategic international agreements with four diabetes companies to advance connected solutions and streamline care for people with diabetes in markets outside of the US.
Three firms launched initial public offerings during the first week of May, but Gyroscope postponed its IPO while Jasper, Science 37 and Roivant took the special purpose acquisition corporation route.