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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.
[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]
[42] [43] At the time, the drug was undergoing clinical trials in humans and not yet under an FDA emergency use authorization (EUA). However, as is typical for experimental drugs, the FDA "expanded access" regulation, technically known as 21 CFR 312.310, allowed Trump's physicians to request "compassionate use" of REGN-COV. [44]
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.
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.
(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 ...
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]
Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), [1] cert denied, 552 U.S. 1159 (2008) was resolved in early 2008 when the Supreme Court of the United States declined to hear the appeal. Their refusal left standing the appellate court decision, which said that patients have no right to ...