Regulations Requiring Manufacturers To Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients

摘要

The Food and Drug Administration (FDA) is proposing new regulations requiring pediatric studies of certain new drug and biological products. Many new drugs and biological products represent treatments that are, at least at times, the best available treatment for children, but most of them have not been adequately tested in the pediatric subpopulation. As a result, product labeling frequently fails to provide directions for safe and effective use in pediatric patients. The proposed rule would attempt to partially address this lack of pediatric use information by requiring that manufacturers of a limited class of new drugs and new biological products provide sufficient data and information to support directions for pediatric use for the claimed indications, before or soon after approval. Manufacturers of a limited class of marketed drugs and biologics would also in compelling circumstances have to provide such data. This proposed rule is part of a comprehensive effort to increase the number of new drugs and biological products with clinically significant use in children that carry adequate labeling for use in that subpopulation.