The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a ...
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, ...
Longitudinal Perceptions of Prognosis and Goals of Therapy in Patients With Metastatic Non–Small-Cell Lung Cancer: Results of a Randomized Study of Early Palliative Care The Study of Tamoxifen and ...
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 ...
In a recent study posted to the medRxiv* preprint server, researchers modeled the benefit-risk of Moderna’s coronavirus disease 2019 (COVID-19) mRNA-1273 vaccine. Study: BENEFIT-RISK ASSESSMENT OF ...
Successful risk management is essential to the design and development of safe and effective medical devices. Unfortunately, it is too often viewed by manufacturers as an isolated activity that must be ...
Tracy Harding, CPA, was on his way to work and looking forward to completing an audit he was working on. But on the way in, he heard a news report that changed the objective of his day. A local ...
Results that may be inaccessible to you are currently showing.
Hide inaccessible results
Feedback