Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

In 2001, chemists K. Barry Sharpless, Hartmuth C. Kolb, and M. G. Finn introduced click chemistry, a concept in which organic ...

Traditionally, developing a new drug takes many years and requires a massive financial investment, often involving significant risk and a high likelihood of failure. AI models trained on extensive ...

George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and ...

Generative AI is transforming pharma’s slowest lane —regulatory affairs — into a fast track for life-saving treatments. Bringing a new drug to market is one of the most expensive and time-consuming ...

Clinical trials for drug development are notoriously slow and expensive, and only a small fraction of drug candidates end up being approved by the regulatory authorities. The extensive bottlenecks in ...

Oxana Iliach is a Senior Director of Regulatory Strategy at Certara (PA, USA), a biotech company that offers comprehensive solutions for transforming and accelerating drug development. In her spare ...

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...