FDA official: We are committed to promoting pediatric drug trials

08/27/2013 | FDA Voice blog

The FDA is posting the first noncompliance letters to pediatric drug trial sponsors that did not seek extensions for deferred studies or seek approval of formulations for children, writes Dr. Lynne Yao, the FDA's associate director of pediatric and maternal health staff for the Center for Drug Evaluation and Research's Office of New Drugs. The letters are among tools that will encourage greater study of how drugs affect children under new laws, Yao writes.

View Full Article in:

FDA Voice blog

Published in Briefs: