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.
WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency
The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.
Irish Body Sets Out Five-Year Vision Strategy For Off-Patent Sector
With a focus on drug accessibility, supply chain resilience, and a balanced approach to sustainability, Medicines for Ireland “calls to action” with its five-year plan.