The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the committee is to provide advice and recommendations to the FDA on regulatory issues. FDA is establishing a docket for public comments.
The PAC will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act (Pub. L. 108-155). On September 11, 2017, the PAC will discuss the use of prescription opioid products containing hydrocodone or codeine for the treatment of cough in pediatric patients. The discussion will include current practice for the treatment of cough in children and benefit-risk considerations regarding the use of prescription opioid products in pediatric patients. On September 12, 2017, the PAC will meet to discuss certain medical products.
More information is available via the Federal Register notice.