McClellan: FDA Has Shared Vaccine EUA-Plus Criteria With Industry

FDA has already shared its criteria for vaccine emergency use authorization directly with vaccine makers, even though the White House continues to stall publication of the guidance, former FDA chief Mark McClellan told House lawmakers Wednesday (Sept. 30). He also refuted White House claims that FDA’s so-called EUA-plus standards are making it too difficult for companies to develop their vaccines. The agency has already articulated the standards to vaccine makers, McClellan said, and manufacturers are already following those criteria. For...