The drug development process necessitates the comprehensive evaluation of a candidate’s therapeutic benefits alongside its potential risks. Benefit–risk assessments are central to this endeavour, ...

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 ...

New approach methodologies (NAMs) aim to address the limitations of animal models by assessing drug efficacy and safety in a more ethical, human-relevant way. The term ‘NAMs’ encompasses several ...

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 ...