The 21st Century Cures Act was passed by the US House of Representatives in July 2015 and is sparking debate in the medical community. The Act aims to get cures from research to medical practice faster and covers everything from discovery to research funding, drug development, Food and Drug Administration approval, and Medicare, writes Dr Nicola Davies in her regular exclusive article for The Pharma Letter.
However, the House Commerce and Energy Committee observes that advances in genetics will require further regulatory reforms and funding before new discoveries can be used in treatment. In addition, there are a number of other concerns.
Is “Accelerated” FDA approval dangerous?
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