Food and Drug Administration:

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

OGC-99-22: Published: Dec 21, 1998. Publicly Released: Dec 21, 1998.

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Pursuant to a legislative requirement, GAO reviewed the Food and Drug Administration's (FDA) new rule on requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. GAO noted that: (1) the final rule would require pediatric studies of certain new and marketed drugs and biological products; (2) it would also partially address the lack of pediatric use information by requiring that manufacturers of certain products provide sufficient data and information to support directions for pediatric use for the claimed indications; and (3) FDA complied with applicable requirements in promulgating the rule.

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