Research in emergency circumstances
Article Abstract:
Regulations concerning clinical research in emergency medicine should be revised and standardized. The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have different regulations that combined include eight conditions that such research must meet in order to proceed. The requirement for informed consent, impossible to obtain under most emergency circumstances, is stifling potentially life-saving research. Researchers claim that the ethical concept of informed consent clashes with the concept of justice in providing better treatment for seriously ill or injured persons. Researchers want to test new emergency treatments for heart attack, head injury, coma and penetrating wounds. While the FDA and NIH reconsider and rewrite their regulations, researchers hope to proceed with treatment evaluations under looser guideline interpretations from institutional review boards.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1995
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Congress moving to improve FDA performance
Article Abstract:
Members of the US Congress are holding hearings on legislation that is aimed at improving the performance of the FDA. One bill, introduced by Senator Nancy Kassebaum, will hopefully improve regulatory practices. The bill would require performance standards for reviews, accelerate the review process, allow access to unapproved drugs for people with life-threatening illnesses, and allow easier approval of drugs for new uses. Members of the Congressional Commerce Committee propose that the FDA contract out steps involved in drug approval. However, it may be difficult to find research companies who will take on such work. Legislation in 1996 may lead to reform of the FDA, but in order to pass, such legislation will probably need bipartisan support.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1996
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Implementing the FDA Modernization Act
Article Abstract:
The FDA Modernization Act of 1997 will bring many changes to the agency. The Act will require 42 new regulations and some agency employees believe compliance with the law could significantly increase their workload. The law would require the development of a database of drugs that are being tested in clinical trials. It will speed up the approval process for many drugs, as has already been done for AIDS and cancer drugs. Companies must alert physicians and consumers when a drug is discontinued and labeling of pediatric drugs will be improved.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1998
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