Approval or Clearance INITIATOR
نویسندگان
چکیده
منابع مشابه
Regulatory approval of new medical devices: cross sectional study
OBJECTIVE To investigate the regulatory approval of new medical devices. DESIGN Cross sectional study of new medical devices reported in the biomedical literature. DATA SOURCES PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval. ELIGIBILI...
متن کاملReporting ethical processes in two Indian journals.
BACKGROUND In biomedical journals, authors are expected to report if the study was carried out in accordance with international and national ethical guidelines and inform readers if approval from ethics committee was obtained and if written informed consent was taken from the participant or legal guardian. AIMS To determine the proportion of research manuscripts in two pediatric journals publ...
متن کاملStatement on publishing clinical trials in Indian biomedical journals
BACKGROUND: In biomedical journals, authors are expected to report if the study wascarried out in accordance with international and national ethical guidelines and informreaders if approval from ethics committee was obtained and if written informed consentwas taken from the participant or legal guardian. AIMS: To determine the proportion ofresearch manuscripts in two pediatric j...
متن کاملRegulatory device approval for stroke: fair and balanced?
See related article, pages 1988–1992. Dr Peña et al provide a regulatory perspective on the Food and Drug Administration’s (FDA) device approval process.1 Reflecting the growing importance of the topic, this is the second such review and accompanying editorial comment to appear in Stroke,2,3 the first being prompted by the FDA’s clearance of the MERCI retriever device.4 For those more familiar ...
متن کاملEthics approval: responsibilities of journal editors, authors and research ethics committees
Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply unaware of its importance. Good research involves risks taken by research p...
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