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Health Care Trends: FDA Amendments, Changes in Store

Executive Summary

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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MDUFMA Part II

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.

Sarepta Scores Another Remarkable Approval With Vyondys 53 For Duchenne

Formal dispute resolution was key element in four-month turnaround from rejection by US FDA to approval for golodirsen, the second Sarepta DMD drug to clear the agency after appearing to have minimal prospects.

Real-World Evidence Fails Another Test At US FDA

Correvio’s attempt to move vernakalant from 'clinical hold' to 'FDA approved' was a huge long shot. But the advisory committee vote – and looming FDA rejection – are another indication that real-world data is not a panacea.

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