Risk assessment, drug approval, and liability.

摘要

The assessment of risk has become even more prominent in discussions of drug approval. The recent congressional hearing on the cyclooxygenase-2 (COX-2) inhibitors and a Food and Drug Administration (FDA) advisory panel meeting has further raised concern as to the effectiveness of clinical trials and the drug approval process in assessing risk. The concerns that risk is not properly being assessed will slow the drug development process and further inhibit the development of new therapies by increasing liability of the pharmaceutical industry.