Simplifying Global Compliance
FDAnews Device Daily Bulletin
Workshop to Focus on Trial Designs for Pediatric Cardiovascular Devices
Sept. 7, 2010
The FDA and NIH will sponsor a public workshop
on clinical trial design for pediatric cardiovascular devices from 8 a.m. to 5:30 p.m. Sept. 30 at the Moscone Center in San Francisco. The workshop will focus on efficient, pragmatic trial designs and statistical analysis methods conducive to overcoming the challenges in developing cardiovascular devices for children. The agency will use the information gathered at the workshop to develop guidance on optimal designs for pediatric cardiology device trials.
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