Expanded Patient Access to Investigational New Devices
نویسندگان
چکیده
منابع مشابه
Practical, legal, and ethical issues in expanded access to investigational drugs.
The Food and Drug Administration (FDA) reviews clinical-trial data for new drugs and determines whether the benefits of these drugs outweigh the risks.1 This requirement, legislated in 1962,2 raised the bar to approval and reduced the likelihood that new drugs would be ineffective or cause major health problems. Developing such data about investigational drugs takes time for the assessment of p...
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On October 27, 2004, the Advisory Committee on Immunization Practices (ACIP) was informed by the only U.S.-licensed manufacturer of varicella zoster immune globulin (VZIG) (Massachusetts Public Health Biologic Laboratories, Boston, Massachusetts) that the company had discontinued production of VZIG. The supply of the licensed VZIG product is now nearly depleted. In February 2006, an investigati...
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When patients are told that standard medical treatment options have been exhausted, their treating physicians may start looking for promising new drugs that are not yet approved, and still under investigation. Some patients can be included in clinical trials, but others cannot. It is not widely known that these patients might still be eligible for trying investigational drugs, in a therapeutic ...
متن کامل(R)evolution: toward a new paradigm of policy and patient advocacy for expanded access to experimental treatments
In life-threatening conditions such as cancer and rare diseases, where there is no cure and no U.S. Food and Drug Administration (FDA)-approved therapy, patients sometimes seek access to an unapproved, experimental therapy through expanded access programs as their last, best hope for treatment to save their lives. Since the 1980s, the policies and the practice of expanded access have evolved, b...
متن کاملExpanded Access Programs
Expanded access is a regulatory mechanism by which an investigational drug can be made available outside of a clinical trial to treat patients with serious or life-threatening conditions for which there are no satisfactory treatment options. An expanded access program (EAP) is the formal plan under which preapproval access to an investigational drug can be provided to a group of patients. Altho...
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ژورنال
عنوان ژورنال: JACC: Basic to Translational Science
سال: 2018
ISSN: 2452-302X
DOI: 10.1016/j.jacbts.2018.06.006