Federal Register Notice
FDA has published a notice in the Federal register ( http://edocket.access.gpo.gov/2009/pdf/E9-22012.pdf ) announcing a 1.5 day public workshop, regarding scientific issues in clinical trial designs for evaluating devices for the treatment of Pediatric patients.
This public workshop is intended to solicit information and comments about and gain perspective from health care providers, academia, and industry on various aspects of clinical trials involving pediatric diseases and patients. Please see Docket No. FDA-2009-N-0407; CDRH 200938. Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs and Clinically Meaningful Safety and Effectiveness Outcomes: Request for Comments. Comments due November 30, 2009.
Federal register Notice
http://www.regulations.gov
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