FDA demonstrates commitment to pediatric drug trials

08/27/2013 | FDA Voice blog

The FDA is publishing this week the first noncompliance letters it issued to pediatric drug trial sponsors that failed to ask approval for a required pediatric formulation or submit deferred pediatric trials by the deadline. The trial sponsors' replies to the letters will also be published on the FDA's public website. This important move clearly shows the FDA's continuous commitment to complete these trials for the benefit of children and infants, writes Dr. Lynne Yao, associate director of pediatric and maternal health staff in the FDA Center for Drug Evaluation and Research's Office of New Drugs.

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