Zdrowie i gospodarka · 25.10.2019

Pediatric Stakeholder Meeting; Public Meeting; Request for Comments

The Food and Drug Administration's (FDA or the Agency) Office of Pediatric Therapeutics (OPT), the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are announcing a public meeting seeking input from patient/ parent groups, consumer groups, regulated industry, academia, and other interested parties to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (see the SUPPLEMENTARY INFORMATION section for additional background information).