haku: @journal_id 1399 / yhteensä: 95
viite: 63 / 95
| Tekijä: | Olson, M. K. |
| Otsikko: | Firm characteristics and the speed of FDA approval |
| Lehti: | Journal of Economics and Management Strategy
1997 : SUMMER, VOL. 6:2, p. 377-401 |
| Asiasana: | COMPANIES DECISION MAKING REGULATIONS |
| Kieli: | eng |
| Tiivistelmä: | Reviewers of new drug application (NDA) in the Food and Drug Administration (FDA) respond systematically to the differences existing between firms and between drugs because the firm and drug characteristics provide information to the reviewer. Some of the information provides a signal of firm reputation or NDA quality, which reduces uncertainty about making error and leads to faster reviews. Other characteristics influence the FDA's perception of the likely feedback that it will receive from patient and professional groups. For new-drug approvals the pattern of variation in review times suggests that reviewers have discretion in the review process. The analysis suggests that regulatory theories of agency behavior such as capture are too general to characterize regulatory decision-making in this agency. |
SCIMA