Measuring the impact of the 2012 European pharmacovigilance legislation on additional risk minimization measures.

CONCLUSION: During the study period, no significant differences in the proportion or trend of products with aRMMs at the time of licensing before and after the pharmacovigilance legislation were identified. PMID: 30107752 [PubMed - as supplied by publisher]
Source: Expert Opinion on Drug Safety - Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research