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Proposed rule
Author(s) -
Donald S. Clark
Publication year - 2016
Publication title -
the brown university psychopharmacology update
Language(s) - English
Resource type - Journals
eISSN - 1556-7532
pISSN - 1068-5308
DOI - 10.1002/pu.30149
Subject(s) - citation , computer science , information retrieval , world wide web
The Food and Drug Administration on April 22 announced a proposed ban on the use of electrical stimulation devices to treat self-injurious or aggressive behavior, stating that labeling changes for the devices would not mitigate “an unreasonable and substantial risk to public health.” The FDA stated in opening a 30-day comment period on its proposal that only one treatment facility, the controversial Judge Rotenberg Educational Center in Massachusetts, is known to be using the devices. The agency added that many of the patients exposed to these devices have limited capacity to communicate their reactions, and there is evidence of physical and psychological risks ranging from pain and burns to depression and symptoms of post-traumatic stress disorder. [www .fda.gov/NewsEvents/Newsroom/Press Announcements/ucm497194.htm] FDA From the reseArch roundup