FDA Releases Draft of Sunshine Law Financial Disclosure Guidelines
Federal health regulators publish guidance for the transparency laws that will officially roll out this August.
The FDA published a draft of the Sunshine Act financial disclosure guidelines that will take full effect by August 1, 2013. The 35-page document details all physician-relationship rules companies will have to follow when applying for marketing applications with the FDA.
This document answers many lingering questions about how reporting should be carried out, how bias is determined and which physician/manufacturer relationships must be reported. The guidance has been updated from a May 2011 version, based on recommendations from 13 individuals and interested parties.