We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » OCP MaPP Requires Briefings on Some Pediatric Supplements
OCP MaPP Requires Briefings on Some Pediatric Supplements
November 6, 2009
Drugmakers that submit pediatric supplement NDAs with potentially complicated or controversial clinical pharmacology or biopharmaceutical issues should be aware that CDER’s Office of Clinical Pharmacology (OCP) is now required to hold briefings on them, according to a revised Manual of Policies and Procedures (MaPP).