An Analysis of the Fixed-Dose Combinations Authorized by the European Union, 2009-2014: A Focus on Benefit-Risk and Clinical Development Conditions

Conclusion:
With off-label use, profitability, and reimbursement threatening the development of FDCs, it is the patients who end up suffering the most. The industry, regulatory bodies, and patients need to unite for the successful development of new FDCs.

Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Sawicki-Wrzask, D., Thomsen, M., Bjerrum, O. J. Tags: Global Perspectives Source Type: research