Regulatory & Ethical Issues

However, unprecedented scientific progress also comes with numerous regulatory challenges. Traditional frameworks designed for one-size-fits-all medicines often fall short when applied to personalized interventions or gene-based therapies. As the pace of innovation continues to increase, regulators are grappling with how to ensure safety and efficacy without stifling innovation. This article explores the key regulatory challenges … Read more

When a drug is approved by a regulatory body like the FDA, it is cleared for use based on rigorous clinical trials that demonstrate its safety and efficacy for a specific use, in a specified population, and at a specified dose. Any use that deviates from these parameters is considered off-label. Off-label drug use can … Read more

The journey from the lab bench to the pharmacy shelf is long, complex, and strictly regulated. Drug development involves years of research, rigorous testing and significant investment. However even the most promising compounds cannot reach patients without passing the test of regulatory approval.  Why Regulation Matters Regulation of drugs is essential to ensuring that medications … Read more