The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a ...

As global economies slowly reopen in the midst of Covid-19, new data we obtained has exposed systemic bottlenecks and vulnerabilities governing manufacturing and supply chain processes. Market ...

Explore the key steps listed below that are involved in identifying, evaluating, and mitigating institutional risks. This process ensures continuous proactive management of potential threats to our ...

A phase II randomized, placebo-controlled, double-blind study of the efficacy and safety of RC-1291 (RC) for the treatment of cancer cachexia ...

Environmental contamination control is a crucial aspect of sterile pharmaceutical manufacturing, and risk management is needed to guarantee that the necessary control procedures are in place. The risk ...