An Institute of Medicine (IOM) committee report, recommends that the FDA take proactive steps to continue monitoring drug safety after initial approval and throughout the market lifecycle. Post-market evidence is far greater than what the FDA has when deciding upon...
Drug development is a complicated, often convoluted process. The ability to predict drug toxicity in humans from nonclinical data remains a major challenge. Since you can’t “erase” an adverse event, optimization of preclinical dose selection is...
Side effect overload on drug labels has less to do with true toxicity and drug safety than with manufacturer liability. Examination of more than 5600 drug labels yielded over half a million side effects. An average drug label and the more commonly prescribed drugs...
All medical products pose risks and postmarketing surveillance is critical to expanding the limited evidence base that exists when new drug products are approved. Through initiation of the Sentinel Initiative (May 2008), the Food and Drug Administration (FDA) is...
Drug safety may be underestimated for chronic-use drugs. The FDA has placed more resources and requirements in evaluating drugs premarket than it does in monitoring what happens to patients after years of taking a medication. Drugs that have recently underscored the...
