FDA Logo links to FDA home page Skip Navigation
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website
horizonal rule
Dockets Management

Up | AC Home Page

Food and Drug Administration

Vaccines and Related Biological Products Advisory Committee

February 20, 2008

Briefing Information

Topic 1



The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

GlaxoSmithKline Biologicals Briefing Document (pdf)



Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.

FDA Briefing Document, FDA Statistical Review and Evaluation; Rotarix, Live Attenuated Human Rotavirus (HRV) Vaccine, Oral (GSK) (html)

FDA Briefing Document, Rotarix (rotavirus vaccine, live, oral) (html)

Errata FDA Briefing Document, Rotarix (rotavirus vaccine, live, oral) (doc) (html)

Page last updated February 15, 2008 kkhorizonal rule
Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA/Dockets Management