A complete response letter is issued by FDA’s Center for Biologics Evaluation and Research when the review of a file is completed and questions remain to be answered prior to approval.
GlaxoSmithKline (GSK) has said that it will work closely with the FDA to prepare its response, which it intends to submit to the agency as soon as possible. The application filed for the GSK cervical cancer vaccine included safety, efficacy and immune response data from clinical trials involving almost 30,000 females aged between 10 and 55 from ethnically and racially diverse populations.
Barbara Howe, vice president and director, North American vaccine development, GSK, said: “We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses. Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring Cervarix to the US market.”