RT Journal Article
SR Electronic
T1 Biomedical Innovation: A Risky Business at Risk
JF Science Translational Medicine
FD American Association for the Advancement of Science
SP 96cm23
OP 96cm23
DO 10.1126/scitranslmed.3002459
VO 3
IS 96
A1 Stack, Richard S.
A1 Harrington, Robert A.
YR 2011
UL http://stm.sciencemag.org/content/3/96/96cm23.abstract
AB Regulatory and financial challenges conspire to stall the development and market approval of breakthrough medical products. Inconsistent parameters are used to assess the safety and efficacy of drugs, biologics, and devices; this glitch in the system introduces uncertainty, slows or blocks product approvals, and increases the costs of product development. Here, we consider how to balance the benefits and risks to the public in the assessment of innovative medical products. We also discuss the Institute of Medicine’s recent report on the medical device approval process.