Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle - a focus on benefits and risks
Conclusions: Almost a quarter of regulatory actions reflected a positive impact on benefits and risks. Also, simultaneous learning about benefits and risks suggests an important role for drug development in risk characterization. These findings may impact regulatory analyses and decision-making.PMID:34263667 | DOI:10.1080/14740338.2021.1952981
Source: Expert Opinion on Drug Safety - Category: Drugs & Pharmacology Authors: Lourens T Bloem Mariana Karomi Jarno Hoekman Menno E van der Elst Hubert G M Leufkens Olaf H Klungel Aukje K Mantel-Teeuwisse Source Type: research