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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.
Participants initially enrolled in the study received 177 Lu dotatate as part of an expanded access program. [6] The FDA granted the application for 177 Lu dotatate priority review and orphan drug designations. [6] The FDA granted the approval of Lutathera to Advanced Accelerator Applications. [6]
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.
[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]
(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 ...
The U.S. health regulator on Wednesday approved the expanded use of Bristol Myers Squibb's cancer cell therapy Breyanzi for the treatment of adults with a type of blood cancer called follicular ...
By Mariam Sunny and Sneha S K (Reuters) -The U.S. Food and Drug Administration has granted accelerated approval for the expanded use of BeiGene's combination drug to treat certain patients with a ...
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...