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FDA plans ahead for personalised and genomic medicine
The US Food and Drug Administration (FDA) has issued a new strategic plan that aims to drive translation of science into health by streamlining product development and improving patient outcomes.
The Strategic Plan for Regulatory Science is intended to allow the regulator to ‘make science based decisions resulting in sound regulatory policy’ and foster innovation, by improving the processes by which new products from research in areas including genomics, personalised medicine, cellular and gene therapies. This includes developing new ways of assessing novel therapies and technologies, drawing on multi-disciplinary expertise, as well as facilitating the development of treatments for ‘special populations’ such as patients with rare or neglected diseases.
New guidance on making applications for the approval of genomic, proteomic, and imaging-based biomarkers, and on how medical device applications are assessed (including consideration of the companion diagnostics) has also been released by the regulator this month.