نتایج جستجو برای: label and off
تعداد نتایج: 16854048 فیلتر نتایج به سال:
This case highlights clinical dilemmas faced by physicians when treating patients with conditions for which there are limited or no FDA-approved treatment options. First, it raises questions about when it is appropriate to prescribe medications for "off-label" indications and what might be the ethical and legal implications of doing so. It also prompts us to consider why pharmaceutical companie...
Introduction Despite their limited licensed indications, anti-IL1 agents are often used in real-life practice for an increasing number of diseases. A national survey to record their off-label use in France was started in January 2011. The survey is coordinated by the French National Reference Centre for Auto-inflammatory Diseases, under the aegis of the “Club Rhumatisme et Inflammation” (CRI).
Introduction. The lack of pediatric clinical trials (PCTs) leads to an off-label drug use (OLDU) in children. Our objective was to analyze the number and design of PCTs and OLDU in children in the past years. Population, material and methods. Observational and retrospective study on PCTs and OLDU in children, conducted from 2007 to 2012 in a 252-bed children's hospital. The number and design of...
The Food and Drug Administration (FDA) provides a barrier to market entry and use of unproven and unsafe products. For prescription drugs, the FDA approval process requires substantial evidence of efficacy and safety for specific clinical situations. Although approval is indication-specific, the FDA has a limited role once a drug is on the market. Recent draft guidelines covering manufacturers'...
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