The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a ...
In late September, the Food and Drug Administration (FDA) released a draft guidance on benefit-risk assessments for drugs and biological products. The draft guidance includes considerations the agency ...
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, ...
Elemental impurity risk management can help biomanufacturers to maintain regulatory alignment and ensure patient safety.
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 ...
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 ...
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