Quality of Regulatory Decision-Making Practices: Issues Facing Companies and Agencies

Conclusions: The findings of this study support the need to further characterize and assess the practices and behaviors of individuals and organizations. Furthermore, the barriers, mainly relating to the influence of biases, should be addressed by developing the general principles of a formal quality decision framework and identifying quality decision-making practices in order to ensure that structured decisions are made throughout the life cycle of medicines.
Source: Therapeutic Innovation and Regulatory Science - Category: Drugs & Pharmacology Authors: Tags: Regulatory Science Source Type: research