Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients; Public Meeting

摘要

The Food and Drug Administration (FDA) is announcing a public meeting to discuss issues related to the agency's proposed rule on regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. The proposed rule, previously announced in the Federal Register, requested written comments and proposed new regulations requiring pediatric studies of certain new drug and biological products. The purpose of the meeting is to provide experts in the field and interested individuals an opportunity to discuss specific issues raised by the proposed rule. The agency is seeking comment and specific data on the proposed rule.