Innogen · News · November 17, 2009

New Policy Brief Published: FDA Orphan Products and FastTrack Programmes

Smarter Regulation of Drug Development: FDA Orphan Products and FastTrack Programmes by
and Dr Christopher-Paul Milne is the latest policy brief in the


'Advances in biomedical sciences are predicted to have enormous impact on the prevention, diagnosis, treatment and cure of disease and disability, for example pharmacogenomics, proteomics, nanotechnologies, micro-arrays, biomarkers, bio-informatics, synthetic biology, and tissue engineering.


On the other hand, the R&D process is increasingly costly, unpredictable and inefficient, so that these advances will not automatically translate into improvements in health care.


The Innogen Centre research programme has identified radical revision of regulatory systems as the key to freeing up innovation in life sciences and this brief considers the role of two initiatives by the US Food and Drugs Administration in contributing to this outcome.'


To read the full policy brief, please download AGLS8 Smarter Regulation of Drug Development (PDF 152 KB)