FDA COMMITTED TO "EXPEDITED REVIEW" OF J&J'S CONFIDE HOME HIV TEST KIT
This article was originally published in The Gray Sheet
Executive Summary
FDA COMMITTED TO "EXPEDITED REVIEW" OF J&J'S CONFIDE HOME HIV TEST KIT, Commissioner David Kessler notified White House Chief of Staff Leon Panetta in a recent memo. Kessler reported that FDA "is working closely with the firm to address all remaining issues." Although the memo does not mention either the sponsor or the product under review at the agency, Johnson and Johnson's Direct Access Diagnostics subsidiary is the only company with a premarket approval application for a home HIV sample kit pending at FDA ("The Gray Sheet" May 30, I&W-2).