FDA clinical trials for HIFU
A phase III clinical study for Ablatherm® HIFU, sponsored by EDAP TMS Inc. has been initiated in the United States. Patients diagnosed with low risk localized prostate cancer were recruited into the study. The recruitment phase of the study is complete and patients are now being followed. Candidates for study participation had to meet study inclusion/exclusion criteria prior to study enrollment.
HIFU has received regulatory clearance and is marketed in Europe, Canada, Australia and others outside of the US. Ablatherm® HIFU is seeking approval for market introduction in the US following FDA requirements including completion of this Phase III Clinical Trial.
BMC Medical Research Methodology at the 35th Annual Conference of the .. — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.
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Does the European clinical trials directive really improve clinical trial approval time?
To facilitate and improve clinical research within Europe, the European Union (EU) adopted in 2001 the Clinical Trials Directive (EUCTD). The aim of this study was to compare duration between submission of a clinical drug trial application and approval by regulatory authorities in EU countries regulated by EUCTD vs. EU countries regulated by local legislation and, second, to compare the duration of regulatory approval in Europe vs. the USA and Australia.