TY - JOUR
T1 - Biomedical innovation
T2 - A risky business at risk
AU - Stack, Richard S.
AU - Harrington, Robert A.
PY - 2011/8/17
Y1 - 2011/8/17
N2 - 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.
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.
UR - http://www.scopus.com/inward/record.url?scp=80051851380&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=80051851380&partnerID=8YFLogxK
U2 - 10.1126/scitranslmed.3002459
DO - 10.1126/scitranslmed.3002459
M3 - Comment/debate
C2 - 21849662
AN - SCOPUS:80051851380
VL - 3
JO - Science Translational Medicine
JF - Science Translational Medicine
SN - 1946-6234
IS - 96
M1 - 96cm23
ER -