Federal Register document

Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act

The Food and Drug Administration's (FDA, Agency, or we) Office of Pediatric Therapeutics, the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research are announcing a public meeting entitled "Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act." The purpose of the public meeting is to seek input from interested parties, including patient/parent/ caregiver groups, consumer groups, regulated industry, academia, and others. This input will enable FDA to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatric drug and biologic development and labeling, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA).