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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.
Emergency Use INDs, also called compassionate use or single-patient INDs, are filed for emergency use of an unapproved drug when the clinical situation does not allow sufficient time to submit an IND in accordance with 21 CFR §§ 312.23, 312.24. These are most commonly used for life-threatening conditions for which there is no standard treatment.
[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]
An FDA decision not to grant fast track status, or any other general dispute, may be appealed to the division responsible for reviewing the application within the Center for Drug Evaluation and Research. The drug sponsor can subsequently utilize the Agency's procedures for internal review or dispute resolution if necessary.
February 12, 2018 AVITA Medical announced that the U.S. Food and Drug Administration (FDA) has approved a significant increase in the number of patients who may be treated in the United States with the ReCell Autologous Cell Harvesting Device under a FDA Compassionate Use Investigational Device Exemption (IDE) program.
Sources: Drug Enforcement Administration, Census Bureau Many counties in the Northeast have moderate to high numbers of doctors certified to treat buprenorphine patients. But just 31 percent of the 7,745 doctors in those areas are certified to treat the legal limit of 100 patients.
A new drug application in the 1930s for sulfapyridine to the United States Food and Drug Administration. The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
The Social Security Administration has added 12 new health conditions under its Compassionate Allowances program, meaning people with these conditions now have faster access to Social Security...