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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 Orphan Drug Act of 1983 is a law passed in the United States to facilitate development of orphan drugs ... and expanded access to the Investigational New Drug ...
[25] [26] However, the drug's manufacturer, Advanced Accelerator Applications, has made this drug available through an expanded access program for patients with neuroendocrine tumors, so it is disputed whether this is a substantiated case of a right to try law being used to gain patients access to an investigational product. [27]
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 ...
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.
The law seeks to increase access to experimental drugs by allowing patients, through their physicians, to request experimental medicines directly from drug manufacturers without involving the FDA. [1] The FDA's expanded access program exists in parallel to the Right to Try Act. There is no legal obligation for drug manufacturers to provide ...
(Reuters) -The U.S. drug regulator has declined to approve expanded use of Dynavax Technologies' hepatitis B vaccine in a section of patients, citing insufficient data over destruction of some ...
On Wednesday, Amgen Inc (NASDAQ:AMGN) announced topline results from its Phase 3 trial evaluating the efficacy and safety of Uplizna (inebilizumab-cdon) for Immunoglobulin G4-related disease, a ...