The US Food and Drug Administration (FDA) on Tuesday announced it will hold a public meeting on 16 May to evaluate ways to apply FDA’s benefit-risk framework throughout the human drug lifecycle and ...
BALTIMORE – Regulators and industry representatives said that a new international guideline for evaluating the benefit-risk profile of new and marketed drugs developed by the Council for International ...
This workshop series provided a venue for stakeholders to discuss structured approaches to characterize and communicate the sources of uncertainty in benefit-risk assessment in drug development and ...
Alternative regulatory pathways for vaccine licensure without traditional Phase III efficacy trials are of increasing priority for epidemic pathogens. Using IXCHIQ, a chikungunya virus vaccine ...
In response to the recent publication on safety concerns related to “ASFV-G-∆I177L” by van den Born et al. (2025), we emphasize the need for a thorough, context-specific risk assessment before drawing ...
The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I ...
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 ...
Please provide your email address to receive an email when new articles are posted on . FDA panel voted 12-2 against approval for obeticholic acid for pre-cirrhotic patients with liver fibrosis due to ...
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