The US Food and Drug Administration (FDA) Division of Applied Regulatory Science
(DARS) moves new science into the drug review process and addresses emergent …

Medical anthropology teaches us of historical disparity in the accessibility of medicines in
the developing world due to their lack of availability and affordability, more particularly of …

Broader discussions around use of PD biomarkers occurred at an FDA and Duke Margolis
Center for Health Policy public workshop in 2021, which is summarized by Florian I et al i.[2] …

Demonstrating biosimilarity entails comprehensive analytical assessment, clinical
pharmacology profiling, and efficacy testing in patients for at least one medical indication, as …

A biosimilar is a biological product that is highly similar to and has no clinically meaningful
differences from a US Food and Drug Administration (FDA)‐approved reference product …

The PROphet test provides a decision-making tool for first-line treatment of non-small cell
lung cancer (NSCLC) patients without driver mutations. The test is based on plasma …

Demonstrating biosimilarity entails comprehensive analytical evaluations, clinical
pharmacolo-gy profiling, and efficacy testing for at least one medical indication in patients …

Additionally, the League's four observing states, with an additional population of 1.7 billion, if
join the group, will form the world's largest consortium to enhance the accessibility of …

Sarfaraz K. Niazi, PhD, explains the FDA's changes to the drug review process, the
significance of each change, and the published pieces of work that helped inform the FDA's …