Primer for advisory panels

CHPA's Scientific Affairs Committee is looking into ways to help improve the advisory committee review process. The SAC is working on "a document that sort of takes...frequently asked questions, and lays out some of the basics as a primer for advisory committee members," according to Committee Chair Ed Hemwall (J&J/Merck Consumer Pharmaceuticals). SAC would seek FDA endorsement of the document and would then provide it to advisory panel members prior to meetings. The document has not yet been drafted, but its purpose would be to "make sure that committee members understand going into the room the fundamentals of OTC study," such as consumer behavior trials and advertising regulation, Hemwall said. The information would "perhaps help reduce some of the off-topic debate and uninformed speculation that often occurs at these meetings," he added...