FDA Pediatric Clinical Trials Workshop:
Unmet Needs, Trial Designs and Clinically Meaningful Safety and Effectiveness Outcomes

GENERAL INFORMATION

There has been a paucity of device focused discussions/workshops about how to best study the safety and effectiveness of devices for pediatric disorders. FDA is planning to hold a public meeting to gather information related to collecting sound scientific information in clinical trials for pediatric devices. Six specialties of pediatric disorders: cardiology/pulmonology, musculoskeletal; genitourinary/renal; GI/abdominal; speech/audiology; and neurological will be discussed; including ways to improve and validate diagnostic testing for pediatric diseases. Clinical/research experts from all specialties will lead the discussions about what data needs to be collected in pediatric device clinical trials.

The general sessions will be broadcast on FDA live. Please click here for more information www.FDALive.com