TY - JOUR
AU - Roberts, Edward B.
AB - Data gathered on 62 products from 26 biomedical firms founded in Massachusetts between 1968 and 1975 show a positive relationship between the level of technological sophistication of a firm's products and the risk associated with the use of those products. Oscar Hauptman and Edward Roberts report the results of their study of the impact of the U.S. Food and Drug Administration's approval process on these firms' resources and time. They found that young firms dealing with medical devices and pharmaceuticals were more sensitive to this regulatory process than those producing medical auxiliary products. Enactment of the 1976 FDA regulations amendment affecting medical devices apparently created a precarious environment for the marketing of new products. The amendment was found to have significant impact beyond its target product area, medical devices and supplies. It also challenged the management of firms producing drugs and Pharmaceuticals.
TI - FDA Regulation of Product Risk and Its Impact Upon Young Biomedical Firms
JF - The Journal of Product Innovation Management
DO - 10.1111/1540-5885.420138
DA - 1987-06-01
UR - https://www.deepdyve.com/lp/wiley/fda-regulation-of-product-risk-and-its-impact-upon-young-biomedical-gIJJS2Zcol
SP - 138
EP - 148
VL - 4
IS - 2
DP - DeepDyve
ER -