An Analysis of Regulatory Timing and Outcomes for New Drug Applications Submitted to Swissmedic: Comparison With the US Food and Drug Administration and the European Medicines Agency
Conclusions:
Results suggest there is no clear evidence that Swissmedic was substantially different in its initial regulatory decisions or SPC recommendations compared with the EMA or FDA.
Source: Therapeutic Innovation and Regulatory Science - Category: Drugs & Pharmacology Authors: Dörr, P., Wadworth, A., Wang, T., McAuslane, N., Liberti, L. Tags: Global Perspectives Source Type: research
More News: Drugs & Pharmacology