💊FDA Meeting
Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act
Summary
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).
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The meeting aims to gather input on pediatric drug development, which may affect regulatory compliance and business strategies for pharmaceutical and biotech companies. Participation allows businesses to voice concerns or suggestions regarding pediatric legislation and drug development, impacting their market approach.