Gardasil Sails Through Committee; Discussions Center On Labeling Language
Executive Summary
Labeling for Merck's Gardasil should emphasize that the link between vaccine-related human papilloma virus types and cervical cancer has not been clearly shown, members of FDA's Vaccines & Related Biological Products Advisory Committee said in recommending approval May 18
You may also be interested in...
Gardasil Anal Cancer Indication: CBER Has No Concerns, But What Will ACIP Think?
A Center for Biologics Evaluation and Research clinical reviewer sees no problem with using an anal dysplasia endpoint, or extrapolating male data to females, to support approval of Merck’s human papillomavirus vaccine Gardasil for prevention of anal cancer.
Gardasil Anal Cancer Indication: CBER Has No Concerns, But What Will ACIP Think?
A Center for Biologics Evaluation and Research clinical reviewer sees no problem with using an anal dysplasia endpoint, or extrapolating male data to females, to support approval of Merck’s human papillomavirus vaccine Gardasil for prevention of anal cancer.
Gardasil Anal Cancer Indication: CBER Has No Concerns, But What Will ACIP Think?
Nov. 17 session is product's third before an FDA advisory committee, but review by CDC's immunization practices panel may be key for utilization and reimbursement.