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Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress.
The act also codified FDA regulations and practice to increase patient access to experimental drugs and medical devices and to accelerate review of important new medications. In addition, the law provided for an expanded database on clinical trials, ClinicalTrials.gov. [7]
A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered investigational in other diseases or conditions. Also called experimental. (NCI) Investigational drug. A substance that has been tested in a laboratory and has gotten approval from the U.S. Food and Drug Administration (FDA) to be tested in people.
On Thursday, the FDA granted accelerated approval to Novartis AG’s (NYSE:NVS) Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction of proteinuria in adults with primary ...
On Monday, Incyte Corporation (NASDAQ:INCY) announced that it will pause enrollment in the ongoing Phase 2 study of MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU). The decision was ...
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) is an ethical protocol developed by the World Health Organization to evaluate the potential use of experimental drugs in the event of public health emergencies.
(Reuters) -AbbVie will buy drug developer Landos Biopharma for up to $212 million as the Humira-maker aims to expand its pipeline of medicines to treat immune system-related illnesses, the ...