Appropriate Governance of the Life Sciences (8) - Smarter Regulation of Drug Development: FDA Orphan Products and FastTrack Programmes

Published: 2009
Author or Editor: Author

Appropriate Governance of the Life Sciences is a series of policy briefs describing Innogen's research on:

• Strategic innovation issues in life sciences
• The governance and regulation of innovation
• The resulting innovation trajectories determining which products are developed and which companies take the lead in developing them.

AGLS 8 - Smarter Regulation of Drug Development: FDA Orphan Products and FastTrack Programmes

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.

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