ARTICLE | Regulation

Few potholes in WinRho's road

March 28, 1994 8:00 AM UTC

WASHINGTON - Despite what was described as suboptimal clinical study design, FDA officials supported Univax Biologics Inc.'s application for WinRho SD at an abbreviated advisory committee meeting last week.

The 1-1/2 hour meeting was held to allow the Blood Products Advisory Committee to discuss the application for treatment of idiopathic thrombocytopenic purpura (ITP), a bleeding disorder, and prevention of Rh isoimmunization. The members were not asked to vote on a recommendation for approval of the product. ...