Incorporation of a Benefit-Risk Assessment Framework Into the Clinical Overview of Marketing Authorization Applications

Conclusions:
Ultimately, such an approach that lends further support to quality decision making would be beneficial to patients who would be treated with new pharmaceutical products.

Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Wolka, A., Warner, M., Bullok, K., Wang, J., Radawski, C., Noel, R. Tags: Product Safety Source Type: research